Study characteristics

Methods

Design: parallel group randomised controlled trial.

Setting: single centre trial. Physical Medicine and Rehabilitation Department, El Demerdash Hospital, Ain Shams University, Egypt. Study conducted in 2015 to 2016

Unit of randomisation: participant

Unit of analysis: tendon

Participants

Details of sampling frame:

Total eligible: 53 participants

Total excluded pre‐randomisation: 20 participants

Baseline characteristics:

Total randomised: 33 participants (45 tendons)

Place and hold group randomised: 15 participants (21 tendons)
Controlled passive group randomised: 18 participants (24 tendons)

Sex distribution:

21 males; 5 females

Place and hold group: not reported
Passive group: not reported

Age: mean (range):

Mean 26.8 years (15 to 60 years)

Place and hold group: not reported
Controlled passive group: not reported

Flexor tendon zones: zone I: 7; zone II: 22; zone III: 7

Inclusion criteria:

• All flexor tendon injuries at all zones of the hand, undergoing surgery

• Patients between the age of 15 and 75 years

Exclusion criteria:

• Patients younger than 15 years, because of higher incidence of tendon rupture

• Patients who are older than 75 years, as they have been shown to have deterioration of hand function scores, and normative data for these patients are not available

• Patients with crush injury with extensive soft tissue loss

• Documented compliance problems (e.g. substance abuse)

• Those with medical conditions preventing repair

• Pre‐existing problems such as arthritis limiting joint motion

Surgical technique for flexor repair:

All flexor tendons were two‐strand repairs. The wound was extended using Bruner incisions, and a flap was raised to expose the tendon preserving the functionally important A2 and A4 pulleys. Pull out suture was made for zone I injury with short distal stump (< 1 cm). The suture materials were 3/0 or 4/0 prolene for core suture modified Kessler technique and 5/0 or 6/0 prolene for epitendinous sutures. Associated digital nerve and arterial injuries were repaired by the 8/0 or 9/0 Ethibond.

Characteristics of participants lost to follow‐up/dropouts and included in analysis:

Total lost to follow‐up: 7 participants (9 tendons)

Place and hold group lost to follow‐up: 4 participants (5 tendons)
Controlled passive group lost to follow‐up 3 participants (4 tendons)

Total available for follow‐up: 26 participants (36 tendons)

Total analysed: 26 participants (36 tendons)

Place and hold group: 11 participants (16 tendons)
Controlled passive group: 15 participants (20 tendons)

Interventions

Intervention 1: Place and hold exercise regimen

Components of the intervention: exercise regimen was commenced at three days after tendon repair. Place and hold mobilisation regimen consisting of passive digit flexion of the affected finger and then the participant tries to maintain the flexed posture through active contraction of the involved muscle for five seconds (i.e. place the finger in the desired flexed position and then participant attempts to hold the finger using their flexor muscles in the same position); individual passive range of motion for all joints; passive flexion active extension. These were progressed to active tenodesis exercises.

Dose: 25 repetitions of each exercise.

Frequency of administration: every waking hour for the first six weeks post‐surgery.

Intervention 2: Controlled passive exercise regimen

Components of the intervention: passive exercise regimen using the modified Kleinert method consisting of composite passive flexion and active extension of the digits plus passive range of motion to each joint of each finger. Exercise regimen was commenced at three days after tendon repair.

Dose: 25 repetitions of each exercise

Frequency of administration: every waking hour for the first six weeks post‐surgery.

Both groups:

Components of the intervention: dorsal blocking orthosis with wrist in 20° flexion, MCP joint in 70° flexion and IP joints in full extension.

Dose: orthosis worn all of the time.

Frequency of administration: worn all of the time for six weeks post‐surgery. At six weeks, the orthosis was discarded.

Outcomes

Outcomes were assessed at six weeks through to six months post‐surgery:

• Function: Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Measured once at six months.

• Adverse events: number of tendon ruptures; number of participants with adherent scar formation; flexion deformity; and tendon lag. Flexion deformity and tendon lag was measured using a goniometer. Degree of flexion deformity at PIP and DIP joints was measured. Then the difference between the passive and active ROM for both joints were measured to assess the FDS and FDP tendon glide/lag. Specific time intervals for measurement not reported.

• Satisfaction with treatment: patients’ satisfaction with their hand function was measured on an analogue scale from 0 (completely dissatisfied) to 10 (completely satisfied). Specific time intervals for measurement not reported.

Funding and conflicts of interest statements

Funding source: not reported
Conflicts of interest: authors report "There are conflicts of interest", but none are described.

Notes

Trial registered: PACTR201708002483416

Unit of analysis is tendons not fingers/participants

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: 'We randomised patients into two groups by random sequence‐generating website' as per clinical trials registry: www.randomizer.org."
Comment: the randomisation sequence appears to have been generated using an adequate method.

Allocation concealment (selection bias)

Low risk

Quote: as per the clinical trials registry, "allocation was determined by the holder of the sequence who is situated offsite".
Comment: it appears that the allocation sequence was concealed by keeping the sequence off site until time of recruitment. An adequate method was used to conceal the allocation sequence.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Comment: not reported but due to the nature of the intervention (participation in an exercise programme) it is unlikely participants were blinded to the intervention group they were assigned. Due to the nature of the intervention, healthcare providers could not be blinded to the intervention.

Blinding of outcome assessment (detection bias)
Self‐reported outcomes

Unclear risk

Comment: non‐blinded participants, who may have had different expectations about the benefits of the intervention they received when rating the Disabilities of the Arm, Shoulder and Hand questionnaire and satisfaction.

Blinding of outcome assessment (detection bias)
Objective outcomes

Unclear risk

Comment: it is not stated whether the outcome assessors were blinded for range of motion and adverse events. We attempted to contact the authors but did not receive a response.

Incomplete outcome data (less than 3 months) (attrition bias)
All outcomes

Low risk

Quote: "A total of 33 patients (45 tendons) were enrolled in the study, and only 26 (36 tendons) continued in the study, as seven patients were lost to follow‐up." Data for each group is also reported.
Comment: the number of participants who dropped out are included in the CONSORT diagram and results section. Data are not clearly reported in the manuscript, and it is unknown at what time point the data reported was collected and when these participants were lost to follow up. The reasons for those lost to follow‐up is also not described. However, the number of drop‐outs per group were similar (3 in the passive group versus 4 in the PAH group. So it is unlikely this has biased the results.

Incomplete outcome data (3 to 6 months) (attrition bias)
All outcomes

Unclear risk

Quote: "We conducted our study for 12 weeks….". However, the DASH appears to have been conducted at six months.

Comment: it is unclear what data were collected beyond 12 weeks. Clarification from the authors was not received on request for further data. The authors do not report when adverse events were measured.

Selective reporting (reporting bias)

Low risk

Comment: all outcomes that were reported in the clinical trials register and in the methods section of the paper are reported in the results.

Other bias (outcomes appropriately analysed)

High risk

Comment: the authors have used the unit of analysis as tendons. However, some of the outcomes that were measured such as range of motion, scar adhesion and DASH are measured at the finger or person level. A unit of analysis error appears to have occurred for these outcomes as measurements are per tendon. No further sources of bias were detected.

Study characteristics

Methods

Study design: parallel group randomised controlled trial

Setting: Sweden

Unit of randomisation: participant

Unit of analysis: digit; thumbs analysed separately

Participants

Details of sampling frame:

Total eligible: 96 participants (106 digits)

Total excluded pre‐randomisation: 0*

Baseline characteristics:

Total randomised: 96 participants (106 digits, 81 fingers and 25 thumbs)

Sex distribution at baseline: 68 males; 28 females

Age: not reported in baseline characteristics

Flexor tendon zone: zone II: 106 digits

Inclusion criteria:

• Flexor tendon injury in zone II of fingers or thumb ‐ undergoing flexor tendon surgery

Exclusion criteria:

• Fractures

• Joint injuries

• Soft tissue defects

• Extensor tendon lesions

• Vascular repairs

Surgical technique for the flexor tendon repair:

Surgery within 24 hours of injury. Repaired with a modified Kessler suture using 4/0 Maxon (Davis and Geck) and a running circumferential 6/0 Prolene (Ethicon) suture.

Characteristics of participants lost to follow‐up/dropouts and included in analysis:

Total drop‐outs: 14 participants (six ruptured in the first three weeks and eight were lost to follow‐up)*

Total available for follow‐up: 82 participants (68 fingers and 23 thumbs)

Total included in analysis: 82 participants (68 fingers and 23 thumbs)

8‐week group: 38 participants (45 digits (35 fingers; 10 thumbs); 15 fingers contributed 2 tendons)

10‐week group:  44 participants (46 digits (33 fingers; 13 thumbs); 12 fingers contributed 2 tendons)

Sex distribution at follow‐up (only reported for those included in analysis):
54 males; 28 females

8‐week group: 28 males; 10 females

10‐week group: 26 males; 18 females

Age: mean ± SD (range) (only reported for those included in analysis):

8‐week group: mean 36 years

10‐week group: mean 38 years

Interventions

Intervention 1: Unrestricted activity from 8 weeks post‐surgery

Components of the intervention: at 6 weeks, participants were instructed in a programme to gradually increase the load on the involved hand, allowing unrestricted activity at eight weeks after the surgery.

Dose: not reported.

Frequency of administration: not reported.

Intervention 2: Unrestricted activity from 10 weeks post‐surgery

Components of the intervention: at 6 weeks, participants were instructed in a programme with slower gradual increase of load on the involved hand allowing unrestricted activity at 10 weeks.

Dose: not reported.

Frequency of administration: not reported.

Both groups:

Components of the intervention: all participants received the same therapy for the first six weeks: dorsal blocking orthosis with transverse palmar component and rubber band traction; week one to four passive exercise regimen; week 5 to 6 active exercise regimen.
Immobilised in a dorsal plaster orthosis from below elbow to the fingertips with the wrist in 30 degrees flexion and the MP joints in > 70 degrees flexion. A passive flexion‐active extension regime was used according to the modified programme described by Karlander et al in 1993. On the first post‐operative day the wound dressing was reduced and another orthosis from below elbow to the PIP joints was applied. Rubber bands were attached to the nails of four fingers. Following FPL repairs a dorsal orthosis was applied from below elbow over the thumb with the wrist in 30 degrees of flexion, and a rubber band was attached to the thumb only. During the first 4 weeks passive flexion through traction on the rubber band and active extension exercises. During weeks five to six, active flexion and extension without load commented, still keeping the dorsal orthosis between exercises. Participants were randomised and enrolled into the study between four and six weeks.*

Dose: orthosis: full time wear except for exercises. Exercise regimen: 6 repetitions of each exercise.

Frequency of administration: for the first six weeks: orthosis applied immediately after surgery, worn all the time except for exercises. Exercise regimen: 10 times per day.

Outcomes

Outcomes were assessed at 8, 16, 24 weeks for intervention 1 group, and 10, 16, 24 weeks for intervention 2 group. Thus, groups were measured on the commencement of the intervention and were only measured at the same time points at 16 and 24 weeks.

• Function: hand function calculated as percentage of the uninjured hand using VAS (at 16 weeks).

• Range of motion: active range of motion was measured using a goniometer placed on the dorsum of the digit.

Goniometric measurements were then used to calculate the following classifications:

• • Buck‐Gramcko classification for fingers and thumbs

  • Louisville classification for fingers

  • Tsuge classification for fingers

• Strength: grip strength calculated as percentage of the uninjured hand**** using Jamar dynamometer (at 16 weeks)

• Time to return to work****

• Other outcomes not reported in this review: distance from the fingertip and middle of the pulp to the distal palmar crease was measured using a ruler.*

Funding and conflicts of interest statements

Funding source: Not reported
Conflicts of interest: Not reported

Notes

* Data provided or clarified by correspondence from the authors
**Fingers and thumbs were grouped together when randomised, but analysed separately for the ROM outcomes.

***Outcomes were measured at different time points in the groups, except for the 6 month time interval. Hence, only six months outcomes were reported in the paper, and in this review.

****Incomplete data reporting for these outcomes prevented their inclusion in this review's analyses.

No clinical trial registration found.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "After the 6th week the patients were randomised into two groups…."; and correspondence received from the authors "Randomization was performed by an independent OT, using concealed envelopes at four weeks after surgery. 120 envelopes had been prepared beforehand. The envelopes were prepared, randomly mixed and then delivered in a pile to the OTs who consecutively picked them up in the order they came. "

Comment: the randomisation sequence appears to have been generated using an adequate method.

Allocation concealment (selection bias)

Low risk

Quote: "After the 6th week the patients were randomised into two groups…."; and correspondence received from the authors "Randomization was performed by an independent OT, using concealed envelopes at four weeks after surgery. 120 envelopes had been prepared beforehand."

Comment: information provided by the authors confirms that the allocation sequence was concealed prior to randomisation. An adequate method was used to conceal the allocation sequence.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Quote: "The rehabilitation was supervised by any OT on duty who was not blinded to the allocation and performed the intermediate measurements at 8, 10 and 16 weeks."

Comment: not reported but due to the nature of the intervention (participation in graded hand function) it is unlikely participants were blinded to the intervention group they were assigned. Due to the nature of the intervention, care providers could not be blinded to the intervention. Participants were not blind to
treatment, and may have had different expectations about the benefits of each intervention, self‐reported outcome (function).

Blinding of outcome assessment (detection bias)
Self‐reported outcomes

High risk

Comment: non‐blinded participants, who may have had different expectations about the benefits of the intervention the received (function using VAS).

Blinding of outcome assessment (detection bias)
Objective outcomes

High risk

Quote: "The rehabilitation was supervised by any OT on duty who was not blinded to the allocation and performed the intermediate measurements at 8, 10 and 16 weeks. The assessor (author 2 or 3) doing the final examination after 24 weeks was however blinded to the rehabilitation program at that point."

Comment: the outcome assessment was blinded at 24 weeks, but not at the earlier time points.

Incomplete outcome data (less than 3 months) (attrition bias)
All outcomes

High risk

Comment: the number of participants and digits contributed to the study was provided via correspondence from the authors. The 82 participants who were included in the analysis does not include (n = 14) drop‐outs. Eight of these were lost to follow‐up. It is unclear from which group the 14 drop‐outs were excluded from or the reasons for lost to follow‐up.This drop‐out rate may have had an impact on the results. No further data could be obtained from the authors.

Incomplete outcome data (3 to 6 months) (attrition bias)
All outcomes

High risk

Comment: the number of participants and digits contributed to the study was provided via correspondence from the authors. The 82 patients who were included in the analysis does not include 14 drop‐outs. Eight of these were lost to follow‐up. It is unclear from which group the 14 drop‐outs were excluded from or the reasons for lost to follow‐up. This drop‐out rate may have had an impact on the results. No further data could be obtained from the authors.

Selective reporting (reporting bias)

High risk

Comment: outcomes were measured at various time points between 6 and 12 weeks. However, these data are not reported in the results section of the publication. Also, without a trial protocol is unclear whether other outcomes were measured but not reported. Correspondence from the authors indicated that these data are no longer available.

Other bias (outcomes appropriately analysed)

Low risk

Comment: randomisation occurred at the participant level. However, some of the outcomes are reported at the participant level (function, strength and work), some at the digit level (range of motion), and some at the tendon level (e.g. ruptures). The number of participants, fingers, thumbs and tendons in each group appears to be clearly stated in the manuscript. No other sources of bias were detected.

Study characteristics

Methods

Study design: parallel group randomised controlled trial

Setting: single centre; Hand Therapy Clinic, Tehran, Iran

Unit of randomisation: participant

Unit of analysis: digit

Participants

Details of sampling frame:

Total eligible: 70 participants

Total excluded pre‐randomisation: 16 participants

Baseline Characteristics:

Total randomised: 54 participants (64 digits)

Passive group: 28 participants (33 digits)

Place and hold group: 26 participants (31 digits)

Sex distribution:

37 males; 17 females

Passive group: 19 males; 9 females

PAH group: 18 males; 8 females

Age: mean ± SD (range)

Passive group: 28 ± 9 years (17 to 50 years)

PAH group: 29 ± 8 years (13 to 47 years)

Flexor tendon zone: zone II: 64 digits

Inclusion criteria:

• Sharp injury

• Repair of both FDP and FDS in zone II

• 12 years and older

• Surgery within two weeks of injury

Exclusion criteria:

• Concomitant fracture /skin loss

• Crush injury

• Thumb flexor tendon injury

• Revascularisation

• Replantation

• Incomplete or multilevel divisions

Surgical technique for flexor tendon repair:

FDP tendon repair: 2‐strand modified Kessler core 3‐0 prolene and simple running Epitendinous suture using 5‐0 prolene. FDS tendon repair: 2 x figure‐of‐eight sutures using 4‐0 prolene.

Characteristics of participants lost to follow‐up/dropouts and included in analysis:

Total available for follow‐up: 54 participants (64 fingers)

Total analysed: 54 participants (64 fingers)

Passive group: 28 participants (33 fingers)

PAH group: 26 participants (31 fingers)

Interventions

Intervention 1: Controlled passive exercise regimen

Components of the intervention: orthosis: dorsal blocking orthosis with rubber band traction (attached to a hook placed on the fingernail and passed under a pulley to cause passive flexion of the IP joints) ‐ the rubber band traction was the only difference between groups and was used to perform the controlled passive exercises. Exercise regimen: passive flexion caused by the rubber band traction followed by active finger extension within the dorsal blocking orthosis. Exercises commenced three days after swelling reduced (this means exercises were started at different time points for each participant).

Dose: orthosis: worn full time. Exercises: minimum of 10 repetitions per exercise.

Frequency of administration: orthosis: worn full time. Exercises: every waking hour for 21 days

Intervention 2: Place and hold exercise regimen

Components of the intervention: orthosis: as described in both groups. Exercise regimen: patients were advised to passively flex their fingers using the other hand with the wrist in 30 degrees of extension (out of the orthosis), and then hold the finger position actively, holding for three to five seconds.

Dose: orthosis: worn full time except for exercises. Exercises: 10 repetitions per exercise

Frequency of administration: orthosis: worn full time except for exercises. Exercises: four times per day for 21 days.

Both groups:

Orthosis: protection of the tendons using a dorsal static blocking orthosis with wrist positioned at 0 to 30 degrees of flexion and the MCP joints in 70 to 90 degrees flexion. Exercises: commenced three days after swelling reduced (this means exercises were started at different time points for each participant). At 21 days, all patients were allowed to actively flex their fingers. At four weeks, gliding exercises (extension of the MP joints while holding IPs in flexion, flexion of the MP joints with IPs in extension and composite flexion). At six weeks, blocking exercises (flexion of the PIP joint while the MCP joint is kept in extension; flexion of the DIP joint when MCP and PIP joints are held in extension) and resistive exercises (e.g. therapist) were initiated. Exercises commenced three days after swelling reduced (this means exercises were started at different time points for each participant).

Dose: not reported.

Frequency of administration: not reported.

Outcomes

Outcomes measured at eight weeks post‐surgery: by an independent research therapist, blinded to group allotment and not involved in the care of the participants.

• Range of motion: TAM of the DIP and PIP joints was measured using a handheld goniometer placed dorsally. The TAM is the total of these two measurements combined. From these goniometric measurements, the Strickland classification for tendon repairs was calculated.*

• Adverse events: tendon ruptures

Funding and conflicts of interest statements

Funding source: not reported
Conflicts of interest: not reported.

Notes

*Unit of Analysis is fingers NOT participants.

No clinical trials registration found.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: " After providing informed consent, patients referred in the first week after surgery to the hand rehabilitation clinic were randomised equally to either place and active hold or modified Kleinert according to a computerized random number generator."

Comment: the randomisation sequence appears to have been generated using an adequate method.

Allocation concealment (selection bias)

Unclear risk

Comment: information was insufficient to reveal whether the allocation sequence was adequately concealed until interventions were assigned. We attempted to contact the authors but did not receive a response.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Comment: there were no self‐reported outcome measures used in this study.

Blinding of outcome assessment (detection bias)
Objective outcomes

Low risk

Quote: "Eight weeks after surgery an independent research therapist not involved in the care of the patients and blinded to group allotment evaluated patients."

Comment: the outcome assessor was blinded to the intervention groups.

Incomplete outcome data (less than 3 months) (attrition bias)
All outcomes

Low risk

Comment: the data set probably was complete as no withdrawals were reported throughout the study period.

Selective reporting (reporting bias)

Unclear risk

Comment: all outcome measures specified in the methods were reported in the results section. However, without a trial protocol, it is unclear whether other outcomes were assessed but not reported.

Other bias (outcomes appropriately analysed)

Low risk

Comment: range of motion was measured for each digit, and was reported with the unit being digits. Other outcomes appeared to have been measured at the participant level as appropriate. It is unlikely that a unit of analysis error occurred. No further sources of bias were detected.

Study characteristics

Methods

Study design: parallel group randomised controlled trial (allocation to the three non‐concurrent intervention groups was not randomised)

Setting: single centre; Medical College Hospital, Chennai, India

Unit of randomisation: participant

Unit of analysis: digit

Participants

Details of sampling frame:

Total eligible: 106 participants (139 digits)

Total excluded pre‐randomisation: not reported

Baseline characteristics:

Total randomised: 72 participants (99 digits) ultrasound groups; 34 (40 digits) control group

Total lost to follow‐up in all groups: 6 participants (8 digits)

Sex distribution: not reported at baseline

Age: not reported at baseline

Flexor tendon zone: zone II: 139 digits

Inclusion criteria:

• Zone II flexor tendon injury ‐ surgery to repair tendons

Exclusion criteria:

• Patients with isolated FDS or FDP tendon

• Multiple level injuries of the flexor tendons

• Associated injury to the extensor apparatus

• Fractures

Surgical technique:

Operations performed by senior residents. 2‐strand modified Kessler Mason suture for tendon repair.

Characteristics of participants lost to follow‐up/dropouts and included in analysis:

Total available for follow‐up: ultrasound (US) groups: 66 participants (91 digits)

Total available for follow‐up: control group: 34 participants (40 digits)

Number included in analyses:

Total analysed: ultrasound group: 66 participants (93 digits)

• US group 1: 24 participants (36 digits)

• US group 2: 18 participants (27 digits)

• US group 3: 24 participants (30 digits)

Total analysed: control group: 34 participants (40 digits)

Attrition: dropouts and exclusions:

• US groups: 6 (2 lost to follow‐up; 4 excluded because of wound dehiscence)

  • US group 1: 2 participants (lost to follow‐up)

  • US group 2: 1 participant (wound dehiscence)

  • US group 3: 3 participants (wound dehiscence)

• Control: none

Sex distribution at follow‐up:

Of 100 followed up: 89 males; 11 females

US group: 59 males; 7 females

Control group: 30 males; 4 females

Age: mean ± SD (range) age at follow‐up:

US group 1: incomplete information (range 10 to 45 years listed for 42 of 66 followed‐up participants)

Control group: 35 years (22 to 50 years)

Interventions

Both intervention groups were immobilised a dorsal plaster of Paris cast for three weeks with wrist in neutral and MCP joints in 70 degrees flexion and commenced the same mobilisation from three weeks.

Intervention: Ultrasound

Components of the intervention:  ultrasound: with the orthosis in place, the dressings were removed. The ultrasound coupling gel was applied to the zone II region. The ultrasound treatment head was placed over the site of the tendon repair and gently moved in order to "iron out the irregularities in the near field and to avoid standing waves due to reflection". Care was taken not to cause undue movements to the repaired finger. After ultrasound therapy, the dressings were reapplied. Standard hand therapy: as described below was commenced at three weeks.

Dose: the dosage of the ultrasound changed twice during the five year recruitment period; this was not randomised and appears to have been selected by the therapist.

Frequency of administration: 5 minutes. Not reported how many sessions were performed and how often they were performed.

• Ultrasound 1: January 2008 to July 2010: ultrasound of 1 MHz frequency at an intensity of 0.7 w/cm² was administered from the seventh post‐operative day. The pulse ratio was 2.8. The duration of the treatment was five minutes. After three weeks, the intensity was increased to 1 w/cm².

• Ultrasound 2: August 2010 to October 2011: ultrasound therapy of 1 MHz frequency at an intensity of 0.3 w/cm² from the third postoperative day. After three weeks, the intensity was increased to 1 w/cm². The pulse ratio was 2.8. The duration of the treatment was five minutes.

• Ultrasound 3: October 2011 onward: ultrasound therapy of 3 MHz frequency at an intensity of 0.5 w/cm² was administered from fifth day post‐operation. The intensity was increased only to 0.7 w/cm² after three weeks. Pulse ratio not specified.

The ultrasound group also received the same standard hand therapy programme as the control.

Control: Standard hand therapy programme

Components of the intervention: orthosis: dorsal plaster of Paris orthosis with wrist in neutral position, MCPs in 70 degrees flexion and IPJs in extension. Hand therapy: three to six weeks, orthosis removed, scar massage; exercise regimen consisting of active exercises, blocking exercises and place hold exercises. Between six to eight weeks: exercise regimen consisting of additional passive stretching and resisted exercises. After eight weeks: lift weights; allowed to return‐to‐work

Dose: orthosis: full time; hand therapy: once per day.

Frequency of administration: orthosis: full time for three weeks; hand therapy: daily from three to at least eight weeks.

Outcomes

Outcomes were assessed at three months post‐surgery:

• Range of motion: active range of motion of PIP and DIP joints (also measured at three weeks and weekly intervals until 12 weeks).* Goniometric measurements were used to calculate:

  • The amount of extensor lag.

  • Strickland classifications reported for total number of digits and percentage of participant for each group.

• Strength: grip strength was measured using a dynamometer**

• Adverse events: wound dehiscence, tendon ruptures

Funding and conflicts of interest statements

Funding source: Medical College Hospital Chenai
Conflicts of interest: none declared

Notes

*All outcomes were measured at 3 months. Although the methods stated that range of motion was also measured weekly from 3 weeks, this was not reported in the results section.

** A unit of analysis error appears to have occurred. This is a per hand level measure where the unit of analysis used was digits.

Clinical Trials Registry of India; Ref: CTRI/2013/04/003576

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "The patients were asked to draw a card indiscriminately from an envelope containing a pack of cards labelled as ultrasound or immobilisation in 2:1 ratio"; and from correspondence received from Geetha: "There were two ultrasound cards for one immobilisation card. Specifically, out of 15 cards, 10 were ultrasound and 5 were immobilisation. Patients were asked to select a card at random from the envelope." However, comparisons are made between the three ultrasound groups, where randomisation did not occur, and it appears that the therapist selected which ultrasound dose was applied to the participant.

Comment: the randomisation sequence appears to have been generated using an adequate method between the ultrasound and the control groups. It is important to note that within the ultrasound group, patients received one of three different ultrasound regimens, which was not randomised.

Allocation concealment (selection bias)

Low risk

Quote: "The patients were asked to draw a card indiscriminately from an envelope containing a pack of cards labelled as ultrasound or immobilisation in 2:1 ratio."; and from correspondence received from Geetha: "Patients were asked to select a card at random from the envelope. The cards were kept in a large opaque envelope. They were not visible to the patient or to the person performing the randomisation."

Comment: although the cards could have potentially be seen during the selection from the one large opaque envelope, the authors reported that precautions were taken to blind the patient and the person performing the randomisation. Thus, it appears an adequate method was used to conceal the allocation sequence.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Comment: there were no self‐reported outcomes.

Blinding of outcome assessment (detection bias)
Objective outcomes

Low risk

Quote: "Results were assessed by an independent observer who was not involved in the study" and from email correspondence from Geetha, "The assessment was done by the physiatrist who was not part of the study. She was blinded to the intervention group of the patients."

Comment: the outcome assessor was blinded to the intervention group.

Incomplete outcome data (less than 3 months) (attrition bias)
All outcomes

Low risk

Comment: no data were collected before 3 months. However, there were few dropouts at 3 months.

Incomplete outcome data (3 to 6 months) (attrition bias)
All outcomes

Low risk

Comment: participants who were lost to follow‐up or were withdrawn from the study due to an adverse event are clearly reported. Withdrawals and how they were dealt with are clearly reported. Also, the number of participants that dropped out from each group were low (range 1 to 3).

Selective reporting (reporting bias)

High risk

Comment: range of motion data were collected at weekly intervals, but only 12 week data were reported in the results section. However it is likely that these data were recorded between 3 to 11 weeks, and therefore it is unlikely to have practical implications. However, without a trial protocol, it is unclear whether other outcomes were assessed but not reported. Additionally, ROM and grip strength is reported in ranges; no means or standard deviations were reported. Authors also used different range classifications that are not consistent across the four groups and are also recorded at different time intervals.

Other bias (outcomes appropriately analysed)

High risk

Comment: grip strength was calculated in a non‐standardised way: % of contralateral side. In the grip strength analysis, it appears that a unit of analysis error has also occurred. The grip strength is reported per digit; however, this is at a per hand not per digit level outcome. For range of motion, authors also appeared to use different range classifications that are not consistent across the four groups and are also recorded at different time intervals.

Study characteristics

Methods

Study design: parallel group quasi‐randomised trial

Setting: multi‐centre; three hospital sites in USA

Unit of randomisation: participant
Unit of analysis: digit

Participants

Details of sampling frame:

Total eligible: not reported

Total excluded pre‐randomisation: not reported

Baseline characteristics:

Total randomised: unclear whether those analysed were also the same number as those randomised

Intervention: unclear whether those analysed were also the same number as those randomised

Control: unclear whether those analysed were also the same number as those randomised

Sex distribution:

Not reported

Age: mean:

Intervention: 26.2 years

Control: 32.8 years

Flexor tendon zone: zone II: 60 digits (analysed)

Inclusion criteria:

• Transection of the FDP or FDS tendon or both in zone II of the hand

• Tendons repaired by an attending surgeon or under his direct supervision

• Only patients with a minimum follow‐up time of six months from repair to re‐examination were included

Exclusion criteria:

• More than one digital nerve or digital artery transection per digit

• Fractures

Surgical technique for flexor tendon repair:

Flexor tendons were exposed through palmar zig‐zag incisions. The proximal tendon stumps were isolated by either flexing the wrist and digits or probing the tendon sheaths with a blunt tendon passer. The tendon stumps were delivered atraumatically into the tendon sheath defect. A funnel shaped enlargement was created in the tendon sheath through the non critical membranous region when necessary to accomplish repair, as described by Lister. The tendons were repaired in the manner described by Kessler and Missim, with 4‐0 braided Dacron sutures (Ethicon, Somerville, New Jersey) under a magnification factor of 3.5. A continuous 6‐0 nylon epitenon suture was used to invaginate the free tendon ends. Digital sheath defects were not repaired. Similar operative technique was reported to have been used across all three sites.

Characteristics of participants lost to follow‐up/dropouts and included in analysis:

Total available for follow‐up: 51 participants (60 digits, 102 tendons)

Total lost to follow‐up: not reported

Total analysed: 51 participants (60 digits, 102 tendons)

CPM group: 26 participants (29 digits, 48 tendons)

Passive group: 25 participants (31 digits, 54 tendons)

Interventions

Intervention: Continuous passive‐motion (CPM) machine
Week 1 to 4:

Intervention components: CPM, light dressings, orthosis: dorsal extension lock orthosis fabricated extending from the proximal forearm to the proximal interphalangeal joints positioned with wrist flexed 30 degrees and metacarpophalangeal joints flexed 45 degrees to be used during CPM use. Palmar straps supporting the forearm, wrist, transverse palmar arch, and proximal phalanges maintained the extremities securely in the orthosis. A second dorsal extension‐block orthosis, which extended to the fingertips, was fabricated during the first therapy session. This was worn if the CPM machine was not in use. In addition to being taught how to apply, operate, and remove the CPM machine, participants were instructed in early motion exercises that were to be performed if the device malfunctioned. The exercises were the same as those taught to participants of group 2.

Technical description of the CPM device and use: CPM 5000, Sutter Biomedical, San Diego, California.
Participant was attached to the CPM and adjusted so that the interphalangeal joints could be moved through an arc of flexion and extension. The goal was to achieve a 60 degree arc of proximal interphalangeal joint motion and a 30 to 40 degree arc of distal interphalangeal joint motion. Typically, it required two therapy sessions to achieve this goal. They were given charts on which to log the length of each CPM session. Therapists verified the record by comparing it with the elapsed‐time read‐out located on the CPM device. The patient was instructed to remove the CPM drive bar from the fingertips and to form a fist gently ten times every two hours during the day. The drive bar was then reattached and the CPM machine reactivated. Passive and active exercises were continued.

Dose: CPM: Both rate and force parameters of CPM motion were maintained at the medium setting: 160 cycles of interphalangeal joint flexion and extension per hour (i.e. one cycle every 25 seconds).

Frequency of administration: commenced one day post‐surgery. Participants were instructed to wear the device for eight to 12 hours a day for six weeks.

Week 5 to 6:

Intervention components: CPM alternated with active exercise regimen. The CPM and splinting were discontinued six weeks postoperatively.
Exercise regimen: active motion was allowed 4 weeks postoperatively. At 6 weeks, isolated interphalangeal joint blocking exercises and gentle composite extension.

Dose: CPM: both rate and force parameters of CPM motion were maintained at the medium setting: 160 cycles of interphalangeal joint flexion and extension per hour (i.e. one cycle every 25 seconds).

Frequency of administration: commenced one day post‐surgery. Participants were instructed to wear the device for 8 to 12 hours a day for six weeks.

Week 8 to 12:

Intervention components: resistive exercises commenced. The exercise regimen gradually progressed to full activity by the 12th postoperative week.

Control: Controlled passive progressed to active exercise regimen

Intervention components: orthosis: dorsal blocking orthosis applied on the first postoperative day, positioned with wrist in 30 degree flexion, the metacarpophalangeal joints in 60 to 70 degree flexion, and the interphalangeal joints either in neutral or flexion through rubber band traction. The protective orthosis was discontinued at six weeks. Exercise regimen:

Week 1 to 4: patients performed active extension exercises to the confines of the orthosis and passive flexion to the distal palmar crease.

Week 4: active finger flexion initiated.

Week 6 to 8: progressive resistive exercises gradually introduced and progressed until full activity achieved.

Week 12: no restrictions.
Dose: the rehabilitation protocol varied slightly in cycle number and duration depending upon the facility at which the patient was treated. The approximate number of cycles of interphalangeal flexion/extension ranged from 120 to 300 cycles a day for the first 6 weeks.

Frequency of administration: the rehabilitation protocol varied slightly in cycle number and duration depending upon the facility at which the patient was treated.

Both groups:

All patients begun therapy at one day post operation. Orthosis: post‐operatively, bulky long‐arm dressings with dorsal plaster splints were applied, with the wrist in 30 degrees flexion and the metacarpophalangeal joints in 70 degrees flexion.

Outcomes

Outcomes were assessed at a minimum of 6 months post‐surgery (mean follow‐up period was 10.8 months (6 to 38 months)):

• Active range of motion: TAM including MCP, PIP and DIP joint motion; active range of motion for PIP and DIP joints. These goniometric measurements were then used to calculate the Strickland classification (reported for number of digits for each classification group).

• Adverse events: tendon ruptures; infections.

Funding and conflicts of interest statements

Funding source: not reported
Conflicts of interest: not reported

Notes

Only patients with a minimum follow‐up time of six months from repair to re‐examination were included. The authors did not report on how many were eligible or randomised into the study, only those whose data were analysed.
Checks of the raw data provided indicated that the authors reported standard errors; we converted these to standard deviations.

No clinical trial registration found.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Quote: "Postoperatively, patients were placed in one of two study groups depending upon the month in which they were born. Group 1 included those patients born in even‐numbered months (February, April, June, August, October, and December). Group 2 consisted of those patients born in odd numbered months (January, March, May, July, September, and November)."

Comment: the sequence appears to have been generated using a quasi‐randomised method.

Allocation concealment (selection bias)

High risk

Quote: "Postoperatively, patients were placed in one of two study groups depending upon the month in which they were born. Group 1 included those patients born in even‐numbered months (February, April, June, August, October, and December). Group 2 consisted of those patients born in odd numbered months (January, March, May, July, September, and November)."

Comment: due to the use of quasi‐randomisation, the allocation sequence was not concealed prior to randomisation.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Comment: there were no self‐reported outcomes.

Blinding of outcome assessment (detection bias)
Objective outcomes

High risk

Quote: "Final evaluations were performed by the therapists…"

Comment: the treating therapists performed the outcome evaluations and thus could not be blinded to the intervention.

Incomplete outcome data (over 6 months) (attrition bias)

High risk

Quote: "Only patients with a minimum follow‐up time of six months from repair to re‐examination were included."

Comment: the number of participants who were randomised into the study is not reported. It is unclear how many participants dropped‐out, and how this might have affected the data analysis.

Selective reporting (reporting bias)

Unclear risk

Comment: all outcomes prespecified in the methods section of the publication, were reported in the results section of the publication. However, without a trial protocol, it is unclear whether other outcomes were assessed but not reported.

Other bias (outcomes appropriately analysed)

Low risk

Comment: participants were randomised per person, but some of the statistical analyses were conducted per digit. The authors state the number of participants/digits/tendons in the analysis. It is unlikely that this would likely impact the outcomes. No further sources of bias were identified.

Study characteristics

Methods

Study design: parallel group randomised controlled trial

Setting: single‐centre; Physiotherapy clinic in Germany

Unit of randomisation: participant

Unit of analysis: unclear

Participants

Details of sampling frame:

Total eligible: not reported

Total excluded pre‐randomisation: not reported

Baseline characteristics:

Total randomised: 62 participants (digits not reported)

Exoskeleton group: 31 (probably)
Exercise group: 31 (probably)

Sex distribution:

44 males; 18 females (not reported by group)

Age: mean (range):

Mean 29.5 years (18 to 60 years) (not reported by group)

Flexor tendon zone: zone II: 62 participants

Inclusion criteria:

• Smooth transection of both flexor tendons in zone II on index, middle or ring fingers in patients between 18 and 60 years

Exclusion criteria:

• Thumbs or small fingers injured (exoskeleton cannot be created)

• Only one flexor tendon injured

• No smooth flexion tendon transection

• Injury outside zone II

• Age of the patient < 18 years or > 60 years

• Secondary diagnoses: diabetes mellitus; circulatory disorders; CRPS (post‐randomisation exclusion)

• Concomitant injuries: lesion of both palmar arteries; additional soft tissue damage

• Re‐rupture of the flexor tendon (post‐randomisation exclusion)

Surgical technique for flexor repair:

Tendons were repaired using absorbable PDS sutures. Two‐strand core Kirchmayer ‐ Kessler sutures (4.0 PDS) and simple continuous epitendinous (6.0 PDS) was used to repair the tendon. In the distal zone II, the radial and ulnar slip of the FDS was repaired using a Z suture (4.0 PDS) or analogue to FDP.

Characteristics of participants lost to follow‐up and included in analysis:

Total excluded from analysis: 3 participants (2 complications and 1 lost to follow‐up)

Total available at 18 weeks follow‐up: 59 participants (digits not reported). Total available at earlier time‐points not reported.

Interventions

Intervention: Exoskeleton

Intervention components: this group commenced use of exoskeleton at two weeks post surgery, three times a week for 30 min administered by the physiotherapists at the hospital. Exoskeleton was attached dorsally on the finger with Velcro with the wrist held in 30 degrees flexion. Due to the circular motion arms of the exoskeleton, the pressure on the extension side of the finger was always perpendicular to the axis of motion. In the beginning of each session, ROM was measured and the exoskeleton was adjusted to the individual finger.

Control: Physiotherapy

Intervention components: participants only received the treatments common to both groups (see below).

Dose: the duration of the treatment was variable.

Frequency of administration: three times a week. Physiotherapy was stopped when the doctor found that the participant had free function or the patient was satisfied with the functional result.

Both groups:

Intervention components: modified Kleinert orthosis consisting of a dorsal blocking splint with rubber band traction applied to the fingertips. All participants were in the hospital for four days post surgery and provided with education and an exercise regimen. Exercises included finger active and passive (if required) extension of the finger in the orthosis. If passive flexion through dynamic pull of the orthosis could not be achieved, patient was advised to assist full flexion with the unaffected hand. Scar management was initiated 2 weeks after surgery following removal of stitches. Arm was bathed in lukewarm chamomile tea, scar massaged, moisturised and orthosis was reapplied. All treatments including were completed in 30 degrees wrist flexion.

Dose: exercises: 10 x each exercise. Scar management: 10 minutes. Chamomile tea bath: not reported.

Frequency of administration: exercises: every hour, for six weeks duration. Scar management: three times per day. Chamomile tea bath: not reported. Moisturiser application: not reported.

Outcomes

Outcomes were assessed at 6, 12 and 18 weeks post‐flexor tendon repair (at following the commencement of treatments):

• Function: DASH score (at 12, 18 weeks).

• Range of motion: reported for each individual joint and total for the digit (at 6, 12, 18 weeks). At 18 weeks, range of motion of contralateral hand was also measured. From the range of movement measurements, Strickland Classification was calculated (at 18 weeks)

• Adverse events: number of tendon ruptures; number of infections, number diagnosed with Sudeck's disease. Extension deficit reported for each individual joint and total for the digit (at 6, 12, 18 weeks).

• Satisfaction with treatment: patient satisfaction and whether they would recommend the treatment (interval of assessment not reported).

• Strength: grip strength (at 18 weeks); pinch strength between thumb and index finger and thumb and affected finger (at 18 weeks).

• Other outcomes not reported in this review: duration of physiotherapy treatment required.

Funding and conflicts of interest statements

Funding source: not reported
Conflicts of interest: none reported

Notes

German language paper ‐ data extracted by translators (see Acknowledgements for translators)

No clinical trial registration found.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Comment: patients were assigned to one of two groups using standardised controlled block randomisation. The allocation was based on a randomisation sheet, created by an established randomisation program.

The randomisation sequence appears to have been generated using an adequate method.

Allocation concealment (selection bias)

Unclear risk

Comment: it appears that the randomisation sequence was kept on a randomisation sheet. However, it is unclear who held this sheet (e.g. external person versus a member of the research team) and whether this sheet was kept for the duration of the recruitment using a concealed method. We attempted to contact the authors but did not receive a response by the time of publication.
Therefore, it is unclear what method was used to conceal the random allocation sequence.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Comment: given the nature of the interventions, participants were not blind to treatment, and may have had different expectations about the benefits of the intervention they received. Given the nature of the interventions, trial personnel (treaters) were not blind to treatment, and may have had different expectations about the benefits of the treatments they were delivering.

Blinding of outcome assessment (detection bias)
Self‐reported outcomes

High risk

Comment: non‐blinded participants, who may have had different expectations about the benefits of the intervention they received.

Blinding of outcome assessment (detection bias)
Objective outcomes

Unclear risk

Comment: it was not reported whether the outcome assessors were blinded to the intervention. We attempted to contact the authors but had not received a response by the time of publication.

Incomplete outcome data (less than 3 months) (attrition bias)
All outcomes

Unclear risk

Comment: participants lost to follow‐up and due to complications have been reported as overall numbers for both groups combined. We are therefore unsure in which group the three excluded participants were assigned and at which time point. In addition, how many participants were randomised to each group is not reported in the publication; we have assumed it was 31 in each group. We attempted to contact the authors to clarify but had not received a response. However, it appears that these were excluded from the analysis, and were likely to be accounted for.

Incomplete outcome data (3 to 6 months) (attrition bias)
All outcomes

Unclear risk

Comment: participants lost to follow‐up and due to complications have been reported as overall numbers for both groups combined. We are therefore unsure in which group the three excluded participants were assigned and at which time point. In addition, how many participants were randomised to each group is not reported in the publication; we have assumed it was 31 in each group. We attempted to contact the authors to clarify but had not received a response. However, it appears that these were excluded from the analysis, and were likely to be accounted for.

Selective reporting (reporting bias)

Unclear risk

Comment: all outcomes prespecified in the methods section of the publication, were reported in the results section of the publication. Also without a trial protocol, it is unclear whether other outcomes were assessed but not reported.

Other bias (outcomes appropriately analysed)

Unclear risk

Comment: participants contributed more than one tendon and data appears to have been reported at the participant level. Therefore, a unit of analysis error may have occurred. We attempted to contact the authors to clarify but had not received a response by the time of publication.

No other sources of bias were identified.

Study characteristics

Methods

Study design: parallel group randomised trial*

Setting: Sweden

Unit of randomisation: participant

Unit of analysis: unclear

Participants

Details of sampling frame:

Total eligible: not reported

Total excluded pre‐randomisation: not reported

Baseline characteristics:

Total randomised: 100 participants (108 digits)

Active group: not reported

Controlled passive group: not reported

Sex distribution: not reported

Age: not reported

Flexor tendon zone: zone II: 108 digits

Inclusion criteria:

• Flexor tendon laceration in zone II, for which surgery was performed.

Exclusion criteria:

Not reported.

Surgical technique for the flexor tendon repair:

Direct tendon repair in zone II.

Characteristics of participants lost to follow‐up and included in analysis:

Not reported

Interventions

Intervention 1: Early active flexion exercise regimen

Intervention component: active flexion exercise regimen for the first three weeks post‐surgery. No other treatments reported in the publication.*

Dose: not reported

Frequency of administration: not reported

Intervention 2: Controlled passive exercise regimen

Intervention components: early controlled passive exercise regimen with rubber band traction (assumed to be attached to a dorsal blocking split). No other treatments reported in the publication.*

Dose: not reported

Frequency of administration: not reported

Both groups: all participants were permitted active mobilisation at 3 weeks after surgery.

Outcomes

Outcomes were measured at 3, 4, 6, 8 weeks; 4 months and 1 year:

• Active range of motion: TAM (goniometric measurement in degrees); DIP joint active motion (in degrees); extension deficit (goniometric measurement in degrees)

• Adverse event: tendon ruptures (unclear if number of participants, digits or tendons);

Funding and conflicts of interest statements

Funding source: not reported
Conflicts of interest: not reported

Notes

*This was a conference proceeding. Hence, very little information was reported in the publication. No other publications of the trial were found.

No clinical trial registration or publication of the full trial found.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "One hundred consecutive patients with flexor tendon laceration in 108 digits were stratified according to type of injuries after having direct tendon repair and were randomised to either early active mobilisation or early controlled mobilisation with rubber band traction."

Comment: there is insufficient information in the publication to judge whether the allocation sequence was generated in a random manner.

Allocation concealment (selection bias)

Unclear risk

Quote: "One hundred consecutive patients with flexor tendon laceration in 108 digits were stratified according to type of injuries after having direct tendon repair and were randomised to either early active mobilisation or early controlled mobilisation with rubber band traction."

Comment: there is insufficient information in the publication to judge whether the allocation sequence was adequately concealed prior to the randomisation.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Comment: due to the nature of the interventions, it is not likely that the participants or the intervention personnel would have been blinded to the intervention. However, no self‐reported measures were reported in the results. As this was a conference proceeding, we are unsure whether there were additional outcomes included.

Blinding of outcome assessment (detection bias)
Objective outcomes

Unclear risk

Comment: it is not reported in the publication whether the outcome assessors were blinded to the intervention. We were unable to contact the authors to clarify.

Incomplete outcome data (less than 3 months) (attrition bias)
All outcomes

Unclear risk

Comment: data were collected at 3, 4, 6 and 8 weeks. Yet, no outcome data were reported for less than 12 weeks in the publication. This was a conference abstract and attempts to contact the authors were unsuccessful and a full paper of the study has not been published.

Incomplete outcome data (3 to 6 months) (attrition bias)
All outcomes

Unclear risk

Comment: it is unclear in the publication the flow through of participants from baseline, to randomisation, to outcome measurement at follow up. The numbers of participants randomised to each group are not provided and no information is provided on whether all of these participants continued through the study to the 12 month follow‐up. Data were collected at multiple intervals but was not reported except at the one‐year interval. This was a conference abstract and attempts to contact the authors were unsuccessful and a full paper of the study has not been published.

Incomplete outcome data (over 6 months) (attrition bias)

Unclear risk

Comment: It is unclear in the publication the flow through of participants from baseline, to randomisation, to outcome measurement at follow‐up. The numbers of participants randomised to each group are not provided and no information is provided on whether all of these participants continued through the study to the 12 month follow‐up. Data were reported for the one year follow‐up; however, there is no reporting of the number of randomised versus followed‐up participants, or dropouts, at this time point. This was a conference abstract and attempts to contact the authors were unsuccessful and a full paper of the study has not been published.

Selective reporting (reporting bias)

High risk

Comment: the conference abstract does not contain a detailed methods section. It is unclear whether selective outcome reporting occurred. Also without a trial protocol, it is unclear whether other outcomes were assessed but not reported. In addition, no standard deviations or p‐values for the outcomes are reported in the abstract.

Other bias (outcomes appropriately analysed)

Unclear risk

Comment: it is unclear in the results whether the number of ruptures that occurred was per person, digit or tendon. A unit of analysis error may have occurred, but this is unclear.

Study characteristics

Methods

Study Design: parallel group randomised trial*

Setting: single‐centre; Welsh Plastic Surgery Centre, UK

Unit of randomisation: participant

Unit of analysis: unclear

Participants

Details of sampling frame:

Total eligible: not reported

Total excluded pre‐randomisation: not reported

Baseline characteristics:

Total randomised: 112 participants

Passive: not reported

Controlled passive: not reported

Sex distribution: not reported

Age: not reported

Flexor tendon zone: not reported

Inclusion criteria:

• Completed division of FDP in zones I to III of the fingers

• Immediate primary repair for the tendons

Exclusion criteria:

• Tendon injuries to the thumb

• Significant crush

• Significant ischaemia

Surgical technique:

Strickland (1985) repairs in zones I to III.

Characteristics of participants lost to follow‐up and included in analysis:

Total available for follow‐up: not reported

Total drop‐outs: not reported

Total analysed: 80 participants (interim analysis)

Passive: not reported

Controlled passive: not reported

Interventions

Intervention 1: Early passive exercise regimen (modified Duran protocol)

Components of the intervention: exercise regimen: early passive flexion without rubber band traction, controlled passive mobilisation regimen (cited as using the modified Duran, Strickland and Glogovac regimen 1990). Isolated and composite passive flexion in the orthosis without the rubber band traction, and both active and passive extension within the orthosis.

Dose: not reported

Frequency of administration: not reported

Intervention 2: Early controlled passive exercise regimen (modified Kleinert protocol)

Components of the intervention: exercise regimen: early controlled passive flexion using rubber band traction, controlled passive flexion with active extension regimen (modified Kleinert Regime, May et al 1992). Active extension exercises and fingers were maintained in passive flexion using rubber band traction orthosis. The rubber band traction allowed the passive movements to be controlled.

Dose: not reported

Frequency of administration: not reported

Both groups:

Components of the intervention: participants were seen within 72 hours of surgery prior to leaving the hospital, and subsequently continued physiotherapy under supervision on an out‐patient basis. In addition, participants were reviewed on a weekly basis by medical staff.

Dose: not reported

Frequency of administration: not reported

Outcomes

Outcomes were measured at 3 and 6 month intervals; additional active ROM was recorded at 6 weeks.

• Active range of motion: goniometric measurements were taken and used to calculate the Strickland classification. They did not report the range of motion data, only the classification data.

• Strength: grip strength (Jamar dynamometer); pinch strength (Jamar dynamometer); maximum finger pressure (Jamar Dynamometer)

Funding and conflicts of interest statements

Funding source: not reported

Conflicts of interest: not reported

Notes

*This was a conference proceeding reporting an interim analysis. Hence, very little information was reported in the publication. The authors were contacted to provide more information about the study methods and results, but no response from the authors was received. No other publications on this study were found.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "A prospective, randomised study was set up at the Welsh Regional Plastic Surgery Centre in July 1992."

Comment: there is insufficient information to determine whether the randomisation sequence was adequately generated.

Allocation concealment (selection bias)

Unclear risk

Quote: "A prospective, randomised study was set up at the Welsh Regional Plastic Surgery Centre in July 1992."

Comment: information was insufficient to reveal the adequacy of allocation concealment.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Comment: due to the nature of the interventions, it is unlikely that the participants or intervention personnel were blinded to the intervention. However, no self‐reported measures were reported. However, since this was a conference abstract outcomes there is insufficient information to make a judgement.

Blinding of outcome assessment (detection bias)
Objective outcomes

Unclear risk

Comment: there is insufficient information to determine whether the outcome assessors were blinded, or not, to the group assignments.

Incomplete outcome data (less than 3 months) (attrition bias)
All outcomes

Unclear risk

Comment: there is no information provided about the flow of participants through the study, reasons for exclusions, attrition or for being excluded from the analysis.

Incomplete outcome data (3 to 6 months) (attrition bias)
All outcomes

Unclear risk

Comment: there is no information is provided about the flow of participants through the study, reasons for exclusions, attrition or for being excluded from the analysis.

Selective reporting (reporting bias)

High risk

The only data reported are quote: "combination of Kleinert and Strickland grading (So et al, 1990). Statistical analysis carried out on the first 80 patients using the paired students t test shows no significant difference in outcome."

Comment: no means, standard deviations of p‐values are reported. Very little data are provided in this conference proceeding.

Other bias (outcomes appropriately analysed)

Unclear risk

Comment: insufficient information is provided in the publication to determine whether a unit of analysis error may have occurred, or whether standardised methods for measuring the outcome were used.

Study characteristics

Methods

Study design: parallel group randomised controlled trial

Setting: single‐centre; Hand surgery unit, Uludag University Medical Faculty, Bursa, Turkey

Unit of randomisation: participant

Unit of analysis: digit

Participants

Details of sampling frame:

Total eligible: not reported

Total excluded pre‐randomisation: not reported

Baseline characteristics:

Total randomised: 25 participants (41 digits)

Laser group: 13 participants (21 digits)

Control group: 12 participants (20 digits)

Sex distribution:

Randomised: 15 males; 10 females

Laser group: 8 males; 4 females*

Control group: 6 males; 6 females*

Age: mean ± SD (range):

23.75 (range: 7 to 43) years

Laser group: 23.75 ± 2.56 years

Control group: 24.0 ± 3.03 years

Flexor tendon zone:

Zone I: 4 (Group 1: 2; Group 2:  2)

Zone II: 13 (Group 1: 6; Group 2: 7)

Zone III: 8 (Group 1: 3; Group 2: 5)

Zone IV: 3 (Group 1: 3; Group 2: 0)

Zone V: 11 (Group 1: 6; Group 2: 5)

Inclusion criteria:

• Flexor tendon injury with/without digital artery and/or nerve injuries in zone I, II, III, IV or V and undergone surgery to repair the flexor tendons

Exclusion criteria:

• Any accompanying injury other than digital artery and/or nerve lacerations

Surgical technique for flexor tendon repair:

No details reported.

Characteristics of participants lost to follow‐up/drop‐outs and included in analysis:

Total available for follow‐up: 25 (41 digits)

Total drop‐outs: 2 tendon ruptures were excluded

Total analysed: 23 (39 digits)

Interventions

Intervention: Low level laser therapy (LLLT)

Components of the intervention: laser: following a whirlpool treatment, laser was applied to four different points with 1 cm intervals along the injury zone. The head of the instrument was held perpendicular to and in slight contact with the skin.

Technical description of the laser device: the infrared‐27 GaAs diode laser instrument (Roland Series Elettronica Pagani) with the wavelength of 904 nm, frequency range of 5–7000 Hz, and maximum power of 27 W, 50 W, or 2734 W.

Dose: frequency: 100 Hz for 130 second duration

Frequency of administration: once per day for 10 weekdays during a two‐week period.

Control: Placebo

Components of the intervention: placebo laser treatment was given by using the same instrument as the intervention group, and placing its head in the same way on the hand but not turning it on.

Dose: 130 second duration

Frequency of administration: once per day for 10 weekdays during a two‐week period.

Both groups:

Components of the intervention: orthosis: modified Kleinert orthosis with a palmar pulley was applied to the injured hand of each patient three days after surgery. Exercise regimen: Washington exercise regimen was implemented for 12 weeks post‐operatively. Additional components: whirlpool (35 °C was applied to the injured hand of the patient for 15 minutes) and laser commenced from days 8 to 21.

Dose: not reported

Frequency of administration: not reported

Outcomes

Outcomes were assessed weekly up to 12 weeks:

• Active range of motion: TAM (measured using a Goniometer). The goniometric results were used to calculate the following classification: Strickland classification (Strickland 1980) and Buck‐Gramcko classification (Buck‐Gramcko 1976).

• Strength: grip strength (Jamar dynamometer) (measured at 12 weeks only). Percentage loss of grip strength in the injured hand was recorded by comparing the values for both hands.

• Other outcomes measured included:** pain: using VAS (before and immediately after treatment period and at 12 weeks). Oedema: volumeter to measure the volume difference between the injured and uninjured hands (before and immediately after treatment, and at 12 weeks). Movement measured using linear (fingertip‐to‐distal palmar crease distance) measurements for each digit (at 12 weeks) were measured.

Funding and conflicts of interest statements

Funding source: not reported
Conflicts of interest: not reported

Notes

* There is an inconsistency in the number of males and females in each group compared with the total number reported in the paper. Authors were contacted for clarification, but no response was received.

**Not an outcome of interest for this review

No clinical trial registration found.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: correspondence received from the authors states that "it was a randomised controlled study. The patients were randomised into two groups using random‐number table."

Comment: an adequate methods was used to generate the randomisation sequence.

Allocation concealment (selection bias)

Unclear risk

Quote: "The patients were assigned into two groups by a second observer other than the one who made the evaluation throughout the study."

Comment: tt appears that someone who was not involved in the treatments assigned the groups. However, there is still insufficient information to determine who this person was and whether an adequate method was used to conceal the allocation sequence.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Quote: study is described as "a placebo‐controlled double‐blind prospective study model".

Comment: participants are likely to have been blinded to the intervention as the placebo group received the same treatment without the machine being switched on. It may not have been possible for the personnel (treaters) providing the intervention to be blinded due to the nature of the intervention, if they were required to change the settings on the laser machine. However, since none of the self‐reported outcomes are outcomes of interest for this review, risk of bias is likely not have occurred.

Blinding of outcome assessment (detection bias)
Self‐reported outcomes

Low risk

Quote: study is also described as " a placebo‐controlled double‐blind prospective study model".

Comment: it is not clearly reported at what level the blinding occurred. Due to the nature of the intervention, the participants were likely to have been blinded. It is unlikely that the care providers were blinded as they would need to set the parameters on the laser machine. It is unclear whether participants were provided with any information from the treating personnel that would make them perceive the laser they received as superior to the placebo. However, since the self‐reported measures were also not outcomes of interest for this review, this is unlikely to have biased the results.

Blinding of outcome assessment (detection bias)
Objective outcomes

Low risk

Quote: "The patients were assigned into two groups by a second observer other than the one who made the evaluation throughout the study." Study is also described as " a placebo‐controlled double‐blind prospective study model".

Comment: it appears that the person who conducted outcome evaluations was blinded to the intervention.

Incomplete outcome data (less than 3 months) (attrition bias)
All outcomes

Unclear risk

Comment: one exclusion reported in each group due to tendon rupture, but no attrition due to drop‐out mentioned in either group. Although not reported, this does not mean that it did not occur.

Selective reporting (reporting bias)

Unclear risk

Comment: all data for the outcomes mentioned in the methods section are reported in the results section. Also without a trial protocol, it is unclear whether other outcomes were assessed but not reported.

Other bias (outcomes appropriately analysed)

Unclear risk

Comment: too little information is provided in the publication to know whether a unit of analysis error may have occurred. Outcomes are reported for digits and it is unclear if grip strength was measured per participant or per digit and how this was accounted for in the analysis. There is also a discrepancy in the number of participants reported in total (25 patients) and the total in gender distribution (24 patients).

Study characteristics

Methods

Study Design: parallel group randomised controlled trial

Setting: single‐centre; Department of Plastic Surgery, 15 Khordad Hospital of Shahid Beheshti University of Medical Sciences, Tehran, Iran; 2015 to 2016

Unit of randomisation: participant

Unit of analysis: participant

Participants

Details of sampling frame:

Total eligible: not reported

Total excluded pre‐randomisation: not reported

Baseline characteristics:

Total randomised: 97 participants (114 fingers)

Laser: 39 participants (46 fingers)

Control: 58 participants (68 fingers)

Sex distribution: not reported at baseline

Age: not reported at baseline

Flexor tendon zone: not reported at baseline

Inclusion criteria:

• Zone I, II and III flexor tendon injuries requiring surgery

Exclusion criteria:

• multiple injuries to one flexor tendon

• simultaneous injuries to bone and extensor tendons

• skin loss

• non‐compliant patients or

• patients under 10 years

• gross contamination of wounds

Surgical technique:

All tendons were repaired with four‐strand repairs. Primary repair was performed under general or regional anaesthesia, 6 to 24 hours following the patient’s admission. The surgery protocol under loop magnification was Brunner incision, repairing flexor tendons by four‐strand modified Kessler core suture method; periphery running suture was performed with 4/0 Nylon, and digital nerve repairing with 10/0 Nylon in 32 patients.

Characteristics of participants lost to follow‐up/drop‐outs and included in analysis:

Total drop‐outs: 20 participants, all in control group

Total available for 4‐week follow‐up:  77 participants (92 fingers)

Total available for 4‐week follow‐up: laser group: 39 participants (46 fingers)

Total available for 4‐week follow‐up: control group: 38 participants (46 fingers)

Sex distribution at follow‐up:

60 males; 17 females

Laser: 31 males; 8 females

Control: 29 males; 9 females

Mean ± SD age:

Laser: 27.85 +/‐ 9.26

Control: 26.72 +/‐ 9.69

Flexor tendon zone distribution:

Zone I: 6 (Laser: 2; Control: 4)

Zone II:  67 (Laser: 37; Control: 30)

Zone III:  19 (Laser: 5; Control: 14)

Interventions

Intervention: Low level laser therapy (LLLT)

Components of the intervention: LLLT as commenced at day two post‐surgery, within the plaster brace.

Technical specification of the LLLT device: Mustang 2000 Laser device (Technical Co., Moscow, Russia) with two probes of red (KLO4) and infrared laser (LO7). The laser probes were placed over the repairing site in the contact method. Red and infrared laser were used to accelerate tendon healing.

Dose: the setting for the red laser was continuous mode, 660 nm, and 2 J/cm2. Infrared laser in pulsed mode, wave 810 nm, 100 Hz, 5.85 J/Cm2. Specification for the LLLT applied: Peak power output 15 W; power density 15 W/cm2; wave length 890 nm; pulse frequency 100 Hz; spot size 0.002 cm2; pulsed duration 130 ns; duration of exposure for each point 60 sec; energy density 5.85 J/cm2.

Frequency of administration: 2 to3 times per week, for 10 sessions over four‐week period.

Control: Placebo

Components of the intervention: placebo low level laser therapy with the power off.

Dose: placebo dose with machine off.

Frequency of administration: 2 to 3 times per week, for 10 sessions over a four‐week period.

Both groups:

Components of the intervention: orthosis: plaster brace with 10 degrees wrist, 90 degrees MCP joint and zero degrees IP joint flexion. Exercise regimen: Kleinert rehabilitation regimen was started within the first 24 hours.

Dose: orthosis: full time for four weeks. Exercise regimen: not reported

Frequency of administration: orthosis: full time for four weeks. Exercise regimen: not reported

Outcomes

Outcome assessment was recorded at four weeks.

• Adverse events: wound infections; tendon ruptures

• Passive range of motion: goniometric measurement of the PIP and DIP joints (after first session of laser, measured at weekly intervals).

• Satisfaction: using a standard questionnaire for life scale, the patients rated their satisfaction with LLLT on an analogue scale from one (dissatisfied) to seven (completely satisfied).

• Other outcomes not of interest to this review: pain severity was reported, using the Wong‐Baker FACES pain rating scale (WBS). Pain was rated from 0 (no pain) to 10 (the worst possible pain) (at each laser or placebo session in both groups).

Funding and conflicts of interest statements

Funding source: Vice Chancellor for research Shahid Beheshti University of Medical Sciences

Conflicts of interest: none declared

Notes

Trial registered: IRCT2017050233783N1

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: " Using the unequal treatment allocation method, patients were randomly divided into two groups… We used the stratified block randomisation scheme with an allocation ratio of 0.6:0.4 to determine the unequal sample size…"
Comment: the randomisation sequence appears to have been generated using an adequate method.

Allocation concealment (selection bias)

Unclear risk

Comment: it is unclear how the allocation sequence was concealed, if at all, until the intervention was assigned.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Comment: although not explicitly stated in the publication, the clinical trials registry states that the study was "double‐blinded". However, there is insufficient information in the publication to know at which level this blinding occurred. Due to the nature of the interventions, it is possible that the participants could have been blinded to the interventions, but this was not explicitly stated. It is also possible that the personnel (treaters) were blinded but this was not explicitly stated.

Blinding of outcome assessment (detection bias)
Self‐reported outcomes

Unclear risk

Comment: although not explicitly stated, the clinical trials registry states that the study was "double‐blinded". However, there is insufficient information in the publication to know at which level this blinding occurred. Due to the nature of the interventions, it is possible that the participants could have been blinded to the interventions, but this was not explicitly stated. It is also possible that the care providers were blinded but this was not explicitly stated.

Blinding of outcome assessment (detection bias)
Objective outcomes

Low risk

Quote: "The two observers, blind to the LLLT group, assessed the data independently."
Comment: it appears that the outcome assessors were blind to the intervention assignment.

Incomplete outcome data (less than 3 months) (attrition bias)
All outcomes

High risk

Quote: "Of 58 patients in the control group, 20 patients did not come back for follow up and 38 patients were treated with involvement of total 46 fingers. None has attended a hand therapy clinic"
Comment: participants lost to follow‐up are outlined in the CONSORT diagram and described in the text. Reasons for lost to follow‐up were stated. This was also accounted for in the analysis and the researchers blocked randomisation at a ratio of 0.6:0.4. However, although documented, this loss to follow‐up (34% of participants in the control group) is high.

Selective reporting (reporting bias)

Low risk

Comment: all data for the outcomes mentioned in the methods and clinical trials registry are reported in the results section. It appears that earlier weekly data may have been collected and not reported. However, it is unlikely that this impacts our judgement of the clinical effectiveness of the treatment.

Other bias (outcomes appropriately analysed)

Unclear risk

Comment: it is unclear whether a unit of analysis error for the range of motion measures has occurred, as it reports participants but this is a digit level measurement.
No further sources of bias were identified.

Study characteristics

Methods

Study design: parallel group randomised trial

Setting: single‐centre; Department of Orthopaedic Surgery, Oslo, Norway

Unit of randomisation: participant

Unit of analysis: digit and participant (where appropriate)

Participants

Details of sampling frame:

Total eligible: 53 patients (73 fingers)

Total excluded pre‐randomisation: 0 patients

Baseline characteristics:

Total randomised: 53 participants (73 fingers)

Active flexion: 24 participants (39 fingers)

Controlled passive: 29 participants (33 fingers)

Sex distribution:

36 males; 14 females

Active flexion: 18 males; 4 females

Controlled passive: 18 males; 10 females

Age: mean (range):

Active: 37 years (18 to 66 years)

Controlled passive: 40 years (19 to 72 years)

Flexor tendon zone:

Zone I: 18 (Active: 12; Control: 6)

Zone II: 47 (Active: 25; Control: 22)

Zone III: 4 (Active: 0; Control: 4)

Inclusion criteria:

• Zone I to III FDP tendon complete laceration injuries

• Closed avulsions, sharp cuts and moderate crush injuries were included if condition of soft tissue allowed for direct skin closure and immediate mobilisation

• Age between 18 to 75 years

• General good health and capacity to follow the specific rehabilitation protocol

Exclusion criteria:

• Thumb injuries

• Replantaions

• Revascularizations

• Concomitant phalanx fractures

• Other injuries needing immobilisation

Surgical technique:

Tendon repairs were performed one to four days after injury. The wound was extended in a zig‐zag fashion and the sheath was opened in the palmar midline with limited pulley release at the site of the repair. The FDP tendon was directly repaired with a two‐strand core suture in a side‐locking loop configuration using 3‐0 braided poly blend polyethylene (FiberWire; Arthrex Co., Naples, FL, USA). The repair was completed with a running epitendinous suture with 5‐0 monofilament nylon (Dermalon; Covidien Ltd, Mansfield, MA, USA) in an interlocking horizontal mattress suture fashion. This repair configuration is similar to the Silfverskold repair, with the differences in use of FiberWire as the suture material and locking loops of the core suture placed on the side instead of the volar surface of the tendon and in use of Dona’s interlocking horizontal mattress suture instead of cross‐stitches in making peripheral sutures. In cases with avulsion or a distal tendon stump too short for placement of a suture, the tendon was reattached with transverse intraosseous loop technique. The core suture was identical to the end‐to‐end repair.

Characteristics of participants lost to follow‐up/drop‐outs:

Total drop‐outs: 8 participants (9 fingers)

Total excluded from analysis for 12 months follow‐up: 8 participants (9 fingers)

Active flexion: 4 participants (2 ruptures and 2 lost to follow‐up)

Controlled passive: 4 participants (1 rupture and 3 lost to follow‐up)

Total available for 12 months follow‐up: 45 participants (63 fingers)

Active flexion: 20 participants (34 fingers)

Controlled passive: 25 participants (29 fingers)

Number of digits included in analyses*:

1 month: active flexion: 37; controlled passive: 42

2 months: active flexion: 36; controlled passive: 32

3 months: active flexion: 36; controlled passive: 31

6 months: active flexion: 32; controlled passive: 30

12 months: active flexion: 34; controlled passive: 29

Interventions

Intervention: Active flexion plus controlled passive exercise regimen

Components of intervention: exercise regimen: additional warm up exercises from day 1 post surgery with additional active extension and passive flexion hourly, followed by active unresisted finger flexions with the rubber bands released. Standard care as below.

Dose: 10 repetitions of active extension/passive flexion; 10 to 20 active flexion.

Frequency of administration: every waking hour for four weeks (starting from day one post‐surgery).

Control: Controlled passive exercise regimen (modified Kleinert protocol)

As described below.

Both groups:

Components of the intervention: dressings: bandages removed on first post‐operative day and spray on dressing applied. Orthosis: standardised dorsal blocking plaster orthosis applied in 0 to 20 degrees wrist flexion and 50 to 80 degrees MCP joint flexion. Splint extended to PIP joint distally. Rubber bands were attached to the nails of the injured finger and pulley placed in the palm (as per modified Kleinert regimen). Exercise regimen: weeks 1 to 4: full passive flexion using other hand, and active extension. Six weeks: active flexion exercises initiated for Standard care group and continued for Intervention group. Graded functional use: Simple activities of daily living (ADL) allowed at six weeks and gradual increasing in load to allow full gripping at 12 weeks.

Dose: orthosis: worn full time for four weeks. Exercise regimen: 20 to 30 repetitions each exercise. Graded functional use: not reported.

Frequency of administration: orthosis: worn full time for four weeks. Exercise regimen: every waking hour. Graded functional use: not reported.

Outcomes

Outcomes were assessed at 1, 2, 3, 6, 12 months after surgery:

• Function: functional use of the injured finger in ADL, using a visual analogue scale, scored from 0 to 10, 10 denoting the best and 0 the worst outcome.

• Active range of motion: movement was evaluated using dorsally placed handheld goniometer. Proportion of fingers with good and excellent functional grading was calculated using:

  • Strickland and Glogovac classification (Strickland 1980)

  • Tang classification (Tang 2007).

• Adverse events: tendon rupture and reoperation; delayed wound healing; superficial wound infection; transitory swelling and tenderness over the tendon sheath; complex regional pain syndrome

• Strength: grip strength (dynamometer) calculated as a mean of three measurements and expressed as a percentage of the contralateral side (only measured at 3, 6 and 12 months); pinch strength (hand pinch meter) calculated as a mean of three measurements and expressed as a percentage of the contralateral side.

Funding and conflicts of interest statements

Funding source: none received
Conflicts of interest: none declared

Notes

The unit of analysis was fingers for the appropriate outcome measures, and participants for appropriate outcomes measures.

No clinical trial registration found.

Additional data was provided by correspondence from the authors including a data table for AROM, grip and pinch strengths, and VAS ADLs with means and SDs for 1, 2, 3, 6 and 12 months.

*Analyses were conducted per digit. We used the number of digits as described in Table 3 of the publication for all our analyses conducted in RevMan.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "We randomised with closed envelopes without any external identification, concealing the allocation until opening. At inclusion, every patient chose an envelope, which was opened after the repair was completed and the orthosis with rubber bands was applied,"; and correspondence received from authors: "The envelops were mixed like cards, then the patients themselves chose one from the deck of envelops, that means the sequence was random."

Comment: it appears that the sequence was generated in a random manner.

Allocation concealment (selection bias)

Low risk

Quote: "We randomised with closed envelopes without any external identification, concealing the allocation until opening. At inclusion, every patient chose an envelope, which was opened after the repair was completed and the orthosis with rubber bands was applied."

Comment: allocation was concealed in opaque envelopes. An adequate method was used to conceal the allocation sequence.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Comment: given the nature of the interventions, participants were not blind to treatment, and may have had different expectations about the benefits of each intervention to the nature of the intervention.

Blinding of outcome assessment (detection bias)
Self‐reported outcomes

High risk

Comment: non‐blinded participants who may have had different expectations about the benefits of the intervention they received when assessing functional use.

Blinding of outcome assessment (detection bias)
Objective outcomes

High risk

Quote: "Two therapists (not blinded to group allocation) performed the registrations."

Comment: the therapists who conducted the outcome assessments were not blinded to group allocation.

Incomplete outcome data (less than 3 months) (attrition bias)
All outcomes

Low risk

Comment: information is provided about the flow of participants through the study, reasons for exclusions, attrition or for being excluded from the analysis. Loss to follow‐up was minimal and unlikely to have influenced the study findings.

Incomplete outcome data (3 to 6 months) (attrition bias)
All outcomes

Low risk

Comment: information is provided about the flow of participants through the study, reasons for exclusions, attrition or for being excluded from the analysis. Loss to follow‐up was minimal and unlikely to have influenced the study findings.

Incomplete outcome data (over 6 months) (attrition bias)

Low risk

Comment: information is provided about the flow of participants through the study, reasons for exclusions, attrition or for being excluded from the analysis. Loss to follow‐up was minimal and unlikely to have influenced the study findings.

Selective reporting (reporting bias)

Unclear risk

Comment: all outcome measures reported in the methods section were reported in the results section of the publication. However, without a trial protocol, it is unclear whether other outcomes were assessed but not reported.

Other bias (outcomes appropriately analysed)

High risk

Comment: it appears that an unit of analysis error has occurred for the measurement of grip strength. Authors reported that they analysed all outcomes per finger digit, however grip strength is a participant level variable. No further sources of bias were found. Furthermore, grip and pinch strength were measured as a percentage of the contralateral side with no controlling for hand dominance.

Study characteristics

Methods

Study Design: parallel group randomised trial

Setting: single‐centre; Department of Hand Surgery, Copenhagen University Hospital, Denmark

Unit of randomisation: participant

Unit of analysis: participant (only contributed one digit)

Participants

Details of sampling frame:

Total eligible: not reported

Total excluded pre‐randomisation: not reported

Baseline characteristics:

Total randomised: 39 participants (39 digits; 39 tendons)

Active: 19 tendons (thumb and digits)

Passive: 20 tendons (thumb and digits)

Sex distribution: not reported

Age: not reported

Flexor tendon zone:

Zone I: 7 (includes one FPL)

Zone II: 32 (includes 5 FPL)

Inclusion criteria:

• Flexor tendon laceration in zone I and II to either fingers or thumbs

Exclusion criteria:

• Not reported

Surgical technique for the flexor repair:

Primary tendon repair was performed within three days of injury. Each group received a different surgical technique.

Active group: modified Kessler suture (Ti‐cron 4.0)

Passive group: grasping suture (Prolene 2.0) and external pull‐out knot technique.

Characteristics of participants lost to follow‐up/drop‐outs and included in analysis:

Total drop‐outs: 6 (lost to follow‐up: 3; tendon ruptures: 3)

Total excluded from analysis: 6 (lost to follow‐up: 3; tendon ruptures: 3)

Interventions

Intervention 1: Active flexion plus active extension exercise regimen (plus modified Kessler suture surgical technique)

Components of the intervention: this group's flexor tendon was repaired with a modified Kessler suture (Ti‐cron 4.0). Exercise regimen: early active controlled mobilisation, active extension and active flexion exercises (described as the May et al. protocol, but no citation or further description provided)

Dose: not reported

Frequency of administration: not reported

Intervention 2: Passive flexion plus active extension exercise regimen (plus grasping suture and external pull‐out knot surgical technique)

Components of the intervention: this group's flexor tendons were repaired with a grasping suture (Prolene 2.0) and external pull‐out knot technique. Exercise regimen: early passive exercise regimen, active extension and passive flexion exercises (described as the Mantero protocol, but no citation of further description provided).

Dose: not reported

Frequency of administration: not reported

Outcomes

Outcomes were measured at one‐year post surgery:

• Active range of motion: TAM. This was used to calculate the Strickland classification for flexor tendon repairs.

• Adverse events: tendon ruptures; tenolysis

Funding and conflicts of interest statements

Funding source: not reported

Conflicts of interest: not reported

Notes

This was a conference proceeding. Hence, very little information was reported in the publication. The authors were contacted to provide more information about the study methods and results, but no response from the authors was received.

No clinical trials registration or publication of the full trial was found.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "This study was conducted as a prospective randomised design…..."

Comment: there is insufficient information in the publication to judge whether the allocation sequence was generated in a random manner.

Allocation concealment (selection bias)

Unclear risk

Quote: "This study was conducted as a prospective randomised design…..."

Comment: there is insufficient information in the publication to judge whether the allocation sequence was adequately concealed prior to the randomisation.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Comment: due to the nature of the interventions, it is not likely that the participants or the intervention personnel would have been blinded to the intervention. However, none of the outcomes were self‐reported.

Blinding of outcome assessment (detection bias)
Objective outcomes

Unclear risk

Comment: there is insufficient information to determine whether the outcome assessors were blinded to the intervention.

Incomplete outcome data (over 6 months) (attrition bias)

Unclear risk

Comment: the conference abstract details that six participants were either lost to follow‐up or had tendon ruptures and therefore were not included in the one year follow‐up. It is not reported which group these drop‐outs occurred in and whether this biased the results.

Selective reporting (reporting bias)

Unclear risk

Comment: the outcomes and methods for measurement are not detailed in the methods section of the conference abstract. It is unclear whether selective outcome reporting occurred. Also, without a trial protocol, it is unclear whether other outcomes were assessed but not reported.

Other bias (outcomes appropriately analysed)

High risk

Comment: groups received different surgical interventions that may have biased the results in favour of one group over another. As it appears that each participant only contributed one digit, it does not appear that an unit of analysis error has occurred. No further sources of bias were identified.

Study characteristics

Methods

Study design: parallel group randomised controlled trial

Setting: single‐centre; Service of Hand Surgery and Microsurgery, Clinica SOS Mao, Porto Alegre, Brazil

Unit of randomisation: participant

Unit of analysis: unclear

Participants

Details of sampling frame:

Total eligible: not reported

Total excluded pre‐randomisation: not reported

Baseline characteristics:

Total randomised: 84 participants (84 digits; 152 tendons)
Active group: 37 participants (37 digits; 68 tendons)
Immobilisation group: 47 participants (47 digits; 84 tendons)

Sex distribution: not reported

Age: mean (range):

Group 1: 32 (20 to 64) years
Group 2: 35 (18 to 66) years

Flexor tendon zone: zone II: 84 digits

Inclusion criteria:

• Complete injury to the superficial and deep flexor tendons at zone II, including FPL

Exclusion criteria:

• Tendon injury in more than one digit

• Tendon lesion

• Associated injuries (fractures, skin lesions, joint lesions, loss of tendon or nerve substance)

Surgical technique for the flexor tendon repair:

Surgery was performed under axillary block and tourniquet. Brunner’s zigzag palmar incisions. Tendon repair was a combined Kessler’s modified technique using 3‐0 synthetic monofilament. A2, A3, A4 pulleys were preserved. Tendon sheath was not sutured. Arterial and nerve injuries, when present, were repaired with 9‐0 synthetic monofilament. All surgeries were performed 7 to 21 days after traumatic injury.

Characteristics of participants lost to follow‐up/drop‐outs and included in analysis:

Total available for follow‐up: not reported

Total drop‐outs: not reported

Total analysed: not reported

Interventions

Intervention: Active exercise regimen

Components of the intervention: exercise regimen: early active mobilisation initiated at 12 hours after tendon repair ‐ active flexion/extension exercises. Orthosis: dorsal splint protection (as per both groups). After re‐operation for an adverse event, the patient was then placed again on the same exercise regimen.

Participants were reviewed weekly during the first month and post‐operative follow‐up ranged from 12 to 36 months.

Dose: 10 repetitions of each movement.

Frequency of administration: every waking hour for 16 hours per day.

Intervention: Immobilisation regimen

Components of the intervention: hand immobilised with a dorsal splint for three weeks; as per both groups (detailed below)

Both groups:

Components of the intervention: hand immobilised in a dorsal orthosis positioned in 30 to 60 degrees wrist flexion and the MCP joints in 90 degrees flexion with the IP joints extended. The orthosis was removed at week 3 post‐surgery. Participants were seen weekly at the clinic during the first month.

Dose: orthosis: worn full time

Frequency of administration: orthosis: worn full time for three weeks

Outcomes

Outcomes were recorded at a minimum of 12 months (mean 22 months, range 12 to 36 months) post‐surgery:

• Active range of motion: goniometric measurements were taken but not recorded as raw data. Instead, this was used to calculate outcomes as per:

  • IFSSH classification

  • Strickland classification

• Adverse events: indication for tenolysis, tendon ruptures; re‐operations. All patients were instructed to jot down any abnormality at once, particularly any unexpected loss of active flexion. Upon suture dehiscence, the patient had an immediate surgical re‐intervention, and that was performed exactly in the same way of the primary tendon suture.

Funding and conflicts of interest statements

Funding source: not reported
Conflicts of interest: not reported

Notes

There is some difficulty identifying the unit of analysis for the analysis: e.g. tenolysis unit of analysis is “cases”. We have assumed that since each participant only offered one digit to the study that a case represents both digit and person. The number of participants in each group was calculated manually from the data provided in the publication.

No clinical trial registration found.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "Patients were prospectively randomised, and divided into two groups."

Comment: there is insufficient information in the publication to judge whether the allocation sequence was generated in a random manner.

Allocation concealment (selection bias)

Unclear risk

Quote: "Patients were prospectively randomised, and divided into two groups."

Comment: there is insufficient information in the publication to judge whether the allocation sequence was adequately concealed until the interventions were assigned.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Comment: given the nature of the interventions, participants were not blind to treatment, and may have had different expectations about the benefits of each intervention.

Blinding of outcome assessment (detection bias)
Objective outcomes

Unclear risk

Comment: it is not reported whether the outcome assessors were blinded to the intervention, or who the outcome assessors were.

Incomplete outcome data (over 6 months) (attrition bias)

Unclear risk

Comment: it is unclear in the publication the flow through of participants from baseline, to randomisation, to outcome measurement at 12 months. It is unclear whether the number of participants reported includes any drop‐outs.

Selective reporting (reporting bias)

High risk

Comment: all outcome measures reported in the methods section were reported in the results section of the publication. However, without a trial protocol, it is unclear whether other outcomes were assessed but not reported. Further, no means or standard deviations for the range of movement measurements were reported.

Other bias (outcomes appropriately analysed)

Unclear risk

Comment: randomisation occurred at the participant level. However, it is sometimes unclear whether some of the outcomes were reported at the tendon level (some participants had two tendons repaired) or at the participant or digit level. Therefore, a unit of analysis error may have occurred.

Study characteristics

Methods

Study Design: parallel group randomised controlled trial

Setting: single‐centre; Department of Plastic Surgery, Netherlands; 2003 to 2005

Unit of randomisation: participant

Unit of analysis: unclear

Participants

Details of sampling frame:

Total eligible: not reported

Total excluded pre‐randomisation: not reported

Baseline characteristics:

Total randomised: 28 participants
Total excluded post‐randomisation: 3 participants (2 fractures intra‐op, 1 participant did not have a tendon injury)

Sex distribution: not reported at baseline

Age: not reported at baseline

Flexor tendon zone: not reported

Inclusion criteria:

• Complete sharp dissection of at least the FDS or FDP tendon in any flexor zone

• 18 to 65 years

• Suitable for tenorrhaphy

• Suitable for dynamic orthosis therapy

• High score (> 72) on the Vividness of Movement Imagination Questionnaire (VMIQ)**

Exclusion criteria:

• Fractures

• Tendon ruptures

• Impaired motor function because of nerve lesion

• Pre‐existing upper extremity disorders

• Low score for vividness of motion imagination (VMIQ) questionnaire for MI group only (one participant moved to control group)

Surgical technique: not reported

Characteristics of participants lost to follow‐up/drop‐outs and included in analysis:

Total available for follow‐up: 25 participants

Total drop‐outs: 0

Total crossed over group: 1 participant allocated motor imagery was crossed over to the control

Total analysed: 25 participants

Intervention (baseline/follow‐up) n = 13/12*

Control (baseline/follow‐up) n = 12/13*

Sex distribution at follow‐up:

Motor imagery: 9 males; 3 females

Control: 9 males; 4 females

Age: mean ± SD (range) at follow‐up:

Motor imagery: 36.1 ± 11.3 years

Control: 31.1 ± 10.0 years

Interventions

Intervention: Motor imagery (MI)

Components of the intervention: participants were instructed to perform active flexion and extension movements mentally during the immobilisation period. The instructions were as follows: “Try to imagine as vividly as possible that you slowly clench your fingers and bend the wrist of your splinted hand. Host this image for 3 seconds. Next, imaging that you straighten your wrist and stretch your fingers. Repeat these imaginary movements 10 times (1 session).” Participants entered the actual number of sessions they performed on a form at the end of each day.

Dose: each imagined movement was performed 10 times held for three seconds

Frequency of administration: 8 sessions per day

Control: Standard care hand therapy

There are no actual specific details of what the control group was provided but it is assumed that they received the treatment that both groups were provided (below), and no additional treatments were provided.

Both groups: Participants of both groups underwent their regular treatment.

Components of the intervention: orthosis: relative immobilisation using a Kleinert orthosis. with a wrist band to enable the fingers to be held in a flexed position. Exercise regimen: during the first four weeks postoperatively, only passive flexion of the finger joints was allowed. At 4 to 6 weeks: place‐and‐hold exercises were also practiced: exercises in which the patient flexes their fingers passively with the help of the hand. The fingers are released and the patient is to hold the fingers in the flexed position.

Dose:orthosis: 6 weeks full‐time wear; wrist band worn only at night.

Frequency of administration: exercise regimen: not reported

Outcomes

Outcomes were assessed at 6, 7, 8, 10, and 12 weeks postoperatively

• Function: measured using two scales. (1) Self‐report measure using Michigan Hand Questionnaire; high score indicates good hand function. (2) Self‐reported hand function using a VAS (0 to 100) was also measured; high score indicates good hand function

• Active range of motion: TAM was measured using a digital goniometer (R500 Range of Motion kit). Total motion per finger was calculated by adding up all joints of one finger. On the basis of all measurements of the IF, MF, RF, and LF of one hand, the average total motion per hand was calculated. A high active total motion score represents a good flexion ability. A ratio with the uninjured hand was calculated.

• Strength at 12 weeks: grip strength (digital dynamometer (H500 Hand Kit)) was calculated using an average of three group strength measurements; pinch strength (digital pinch meter (H500 Hand Kit)‐ calculated using an average of pinch strength between the thumb and each finger was recorded.

• Other outcomes not of interest in this review: Vividness of Movement Imagination Questionnaire (pre‐op) for MI group only; number of outpatient appointments in 12 week period following surgery; number of recorded MI sessions; preparation time of finger flexion (indicator of central control processes).

Funding and conflicts of interest statements

Funding source: not reported
Conflicts of interest: not reported

Notes

Participants of the motor imagery group had significantly more injured tendons per person (2.3 ± 0.5) compared with the control group (1.5 ± 1.0).

One participant allocated motor imagery was found to have a low VMIQ score (< 72) and was crossed‐over into the control group. However, the participant flow diagram in the trial report does not make this clear.

*There also appears to be an error in Figure 1 (page 555) of the trial report with respect to the number of participants at baseline and follow‐up in each group. This could reflect that one participant was crossed‐over from the motor imagery group to the control group; but this is not made clear.

No clinical trial registration found.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "After inclusion, subjects were admitted at random to either the control group of the motor imagery group…."

Comment: it is unclear how the random sequence was generated.

Allocation concealment (selection bias)

Unclear risk

Quote: "After inclusion, subjects were admitted at random to either the control group of the motor imagery group…."

Comment: it is unclear how the random allocation sequence was concealed until the interventions were assigned.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Comment: given the nature of the interventions, participants were not blind to treatment, and may have had different expectations about the benefits of each intervention.

Blinding of outcome assessment (detection bias)
Self‐reported outcomes

High risk

Comment: non‐blinded participants, who may have had different expectations about the benefits of the intervention they received self‐reported some outcomes.

Blinding of outcome assessment (detection bias)
Objective outcomes

Unclear risk

Comment: there is insufficient information to determine whether the outcome assessor was blinded to the intervention group.

Incomplete outcome data (less than 3 months) (attrition bias)
All outcomes

Unclear risk

Comment: there are some discrepancies with the PRISMA flow chart numbers and the numbers of participants at baseline and 12 week follow‐up in the publication. It is unclear how any dropouts were accounted for in the analysis.

Selective reporting (reporting bias)

High risk

Comment: in the methods section, most outcomes were recorded at 6, 7, 8 and 10 weeks. However, only the 12 week data are reported in the publication. Also, without a trial protocol, it is unclear whether other outcomes were assessed but not reported. Means and standard deviations for main outcomes were also not reported.

Other bias (outcomes appropriately analysed)

High risk

Comment: it is unclear whether a unit of analysis error may have occurred with the pinch strength measurements: in the methods it states that pinch strength was measured for each digit, and for a number of participants more than one tendon was damaged.

Study characteristics

Methods

Study design: parallel group randomised trial

Setting: multi‐centre; eight hand surgery centres, Washington, USA

Unit of randomisation: participant

Unit of analysis: participant and digit (as appropriate)

Participants

Details of sampling frame:

Total eligible: 103 participants (119 digits)

Total excluded pre‐randomisation: 0 participants (0 digits)

Baseline characteristics:

Total randomised: 103 participants (119 digits)

Place and hold group: 52 participants (61 digits)

Controlled passive group:  51 participants (58 digits)

Sex distribution: not reported at baseline

Age: not reported at baseline

Flexor tendon zone: zone II: 119 digits

Inclusion criteria:

• 15 years or older

• Zone II repairs

Exclusion criteria:

• 76 years or older

• Concomitant fractures, vascular injuries requiring arterial repair, crush injury with soft‐tissue loss

• Documented compliance problems (e.g. substance abuse)

• Medical conditions preventing repair

• Pre‐existing problems such as arthritis limiting joint motion

• Single tendon injuries

Surgical technique:

Patients had operation within 48 hours of injury.  Skin incision left to discretion of surgeon – most were Bruner incision for oblique lacerations, mid‐axial incisions for transverse lacerations. All repairs were 4‐strand using Strickland technique with 3‐0 polyester for two core sutures, and 6‐0 monofilament Prolene for running epitendinous suture. No repair of the tendon sheath was done. The two slips of the FDS were repaired with a simple core Kessler sutures with 3‐0 polyester.  When nerves were injured, they were repaired with microsurgery.

All participants had zone II repairs– multiple fingers.

Characteristics of participants lost to follow‐up/drop‐outs and included in analysis:

Total available for 12‐month follow‐up: 93 (106 digits)

Place and hold group: 47 participants (54 digits)

Controlled passive group:  46 participants (52 digits)

Total analysed (excluding tendon ruptures): 89 participants (102 digits) at 12‐month follow‐up

Place and hold group: 46 patients (52 digits)

Controlled passive group: 44 patients (50 digits)

Sex distribution at follow up:

63 males; 30 females

Age: mean (range) at follow up:

Mean 29 years (15 to 51 years)

Place and hold: 28 (16 to 51) years

Controlled passive: 32 (15 to 49) years

Interventions

Intervention 1: Place and hold exercise regimen

72 hours to 4 weeks post‐surgery:

Components of the intervention: exercise regimen: place and hold and passive exercise programmes using a hinged orthosis (specific for the exercise regimen) that allows for wrist extension while still maintaining the MCP joints in flexion initiated on day 3 post‐surgery. Participant completed place and hold exercise regimen within the orthosis ‐ passively, the wrist is placed into 30 degrees extension, while fingers are pushed passively intro flexion; participant gently contracts the finger flexors to attempt to hold the flexed position, and then relaxes and allows the wrist to drop into flexion and the fingers to extend. Orthosis: between therapy sessions, patients were managed with a static dorsal blocking orthosis that maintained the wrist and MCPJs in flexion.

Dose: each place and hold exercise is held for five seconds. Number of repetitions not reported. Orthosis: dorsal blocking splint is worn full time between exercise sessions.

Frequency of administration: exercise regimen: Hourly. Orthosis: dorsal blocking splint is worn between exercise sessions.

2 to 4 weeks:

Components of the intervention: exercise regimen: place and hold and passive exercises that were now performed without the tenodesis orthosis. Orthosis: between therapy sessions, participants continue to wear dorsal blocking orthosis.

Dose: each place and hold exercise is held for five seconds. Number of repetitions not reported. Orthosis: dorsal blocking splint is worn full time between exercise sessions.

Frequency of administration: exercise regimen: hourly. Orthosis: dorsal blocking splint is worn between exercise sessions.

4 weeks:

Components of the intervention: exercise regimen: tenodesis exercises without an orthosis. Active movement from full fist, to hook fist to straight fist to full finger extension commenced. Orthosis: between therapy sessions, participants continue to wear dorsal blocking orthosis.

Dose: each place and hold exercise is held for five seconds. Number of repetitions not reported. Orthosis: dorsal blocking splint is worn full time between exercise sessions.

Frequency of administration: exercise regimen: not reported. Orthosis: dorsal blocking splint is worn between exercise sessions.

5 weeks:

Components of the intervention: exercise regimen: week 4 exercises plus active wrist and finger flexion following by wrist and finger extension. Orthosis: between therapy sessions, participants continue to wear dorsal blocking orthosis.

Dose: number of repetitions not reported. Orthosis: dorsal blocking splint is worn full time between exercise sessions.

Frequency of administration: exercise regimen: not reported. Orthosis: dorsal blocking splint is worn between exercise sessions.

6 weeks:

Components of the intervention: exercise regimen: active finger flexion exercises with joint blocking are added to the regimen. Buddy taping may be applied to facilitate flexion. Orthosis: discontinue wear.

Dose: exercise regimen: not reported

Frequency of administration: exercise regimen: not reported

7 weeks:

Components of the intervention: exercise regimen: passive extension exercises and extension splints may be used when indicated.

Dose: as needed.

Frequency of administration: as needed.

9 weeks:

Components of the intervention: light strengthening commenced.

Dose: not reported.

Frequency of administration: not reported.

10 to 14 weeks:

Components of the intervention: progressive strengthening programme to regain pre‐operative strength. Unrestricted activity allowed at 14 weeks.

Dose: not reported. 

Frequency of administration: not reported.

Intervention 2: Controlled passive exercise regimen

Combined protocols from both the Duran (passive exercise program) and Kleinert (rubber band traction) passive motion rehabilitation program allowed patients to come out of the rubber‐band traction to perform the passive Duran therapy with the therapist. Only the injured digit was placed in the Kleinert rubber‐band traction.

24 hours to 3 weeks:

Components of the intervention: orthosis: long arm dorsal blocking orthosis. Exercise regimen: all participants commenced an active extension and passive flexion exercise regimen. Oedema management: participants were provided with compressive wraps within 24 to 72 hours post‐surgery.

Dose: orthosis: full‐time wear for 72 hours. Exercise regimen: not reported. Oedema management: not reported.

Frequency of administration: orthosis: full‐time wear from immediately post‐surgery until commenced hand therapy (within 72 hours). Exercise regimen: not reported. Oedema management: not reported

3 to 6 weeks:

Components of the intervention: exercise regimen: place and hold exercises commenced. Orthosis: rubber band traction applied to a dorsal blocking orthosis and wrist position changed to neutral.

Dose: not reported

Frequency of administration: not reported

6 to 9 weeks:

Components of the intervention: exercise regimen: passive extension of isolated joints, combined joint finger extension exercises with wrist flexed. and light function commenced. Orthosis: wean from dorsal blocking splint.

Dose: not reported

Frequency of administration: not reported

9 to 12 weeks:

Components of the intervention: exercise regimen: blocking exercises for PIP and DIPJs, progressive resistive exercises. Orthosis: commence static progressive splinting and/or gentle extension splinting for joint contractures as needed.

Dose: not reported

Frequency of administration: not reported

12 to 14 weeks:

Components of the intervention: light to moderate resistive activities.

Dose: not reported

Frequency of administration: not reported

16 weeks:

No precautions

Both groups: 

24 to 72 hours post‐surgery:

Components of the intervention: orthosis: Long arm dorsal blocking orthosis. Exercise regimen: all participants commenced an active extension and passive flexion exercise regimen. Oedema management: participants were provided with compressive wraps within 24 to 72 hours post‐surgery.

Dose: orthosis: full‐time wear for 72 hours. Exercise regimen: not reported. Oedema management: not reported.

Frequency of administration: orthosis: full‐time wear from immediately post‐surgery until commenced hand therapy (within 72 hours). Exercise regimen: not reported. Oedema management: not reported.

(Full protocol available in the appendix of the publication)

Outcomes

Outcomes measured at 6, 12, 26, 52 weeks:

• Self‐reported functional use: using the DASH questionnaire (at 1 year).

• Active range of motion: (1) Combined active range of motion of the PIP and DIP joints using a goniometer (at 6,12, 26, 52 weeks). (2) Flexion contracture measured using a goniometer (at 6,12, 26, 52 weeks)

• Satisfaction: satisfaction with their hand function on an analogue scale from 1 (dissatisfied) to 10 (completely satisfied) (at 1 year).

• Objective assessment of function: (1) Hand dexterity using the Jebsen‐Taylor hand function score (at 1 year). (2) Hand dexterity using the Purdue Pegboard (at 1 year).

• Return to work: return to full duty work, reported as total days from injury to return to work date.

• Other outcomes not included in this review: costs of surgery, therapy, and medications.

Funding and conflicts of interest statements

Funding source: Orthopaedic Research and Education Foundation (external funding agency)
Conflicts of interest: authors reported that one or more of the authors had financial disclosures related to the project to declare.

Notes

No clinical trial registration found.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Each centre had a research coordinator who enrolled the patients and randomised the treatments. The research coordinator performed the randomisation by drawing a card indiscriminately from an envelope with an equal number of cards labelled active or passive before the patient started therapy."

Comment: the randomisation sequence appears to have been generated using an adequate method.

Allocation concealment (selection bias)

Low risk

Quote: the research coordinator performed the randomisation by drawing a card indiscriminately from an envelope with an equal number of cards labelled active or passive before the patient started therapy."

Comment: the allocation sequence appears to have been adequately concealed prior to assignment of interventions.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Comment: insufficient information to determine from the publication. However, given the nature of the interventions (participation in an exercise programme with orthoses), participants could not be blinded to treatment, and may have had different expectations about the benefits of each intervention.

Blinding of outcome assessment (detection bias)
Self‐reported outcomes

High risk

Comment: non‐blinded participants, who may have had different expectations about the benefits of the intervention they received self‐reported some outcomes.

Blinding of outcome assessment (detection bias)
Objective outcomes

High risk

Quote: "The therapist who performed the therapy also recorded the measurements of motion, sensation and dexterity so they could not be blinded…"

Comment: the outcomes assessors were not blinded to the group allocations.

Incomplete outcome data (less than 3 months) (attrition bias)
All outcomes

Unclear risk

Comment: only range of motion data were collected at the six week time point. It is unclear whether this is a complete data set or participants were lost to attrition at these time points, as the number of participants included in the assessments are not reported. Just because it is not reported we can not assume it is a full data set.

Incomplete outcome data (3 to 6 months) (attrition bias)
All outcomes

Unclear risk

Comment: it is unclear how many participants were loss to follow‐up at 3 and 6 month evaluation. Only range of motion was measured at the 3 and 6 month evaluation.

Incomplete outcome data (over 6 months) (attrition bias)

Low risk

Quote: "Ten patients (13 digits) were lost to follow up, resulting in 93 patients and 106 injured digits who completed the 12‐month follow up evaluation."

Comment: the number of participants and digits lost to follow‐up were reported. However, it is unclear how these participants differed to those who were analysed at the earlier time points for range of motion, or how these drop outs may have affected the data. Although, the loss to follow‐up appears to be accounted for the 12 months evaluation at which time the majority of the outcomes were measured.

Selective reporting (reporting bias)

Unclear risk

Comment: the outcomes were reported as per the pre‐specified methods section. However, without a trial protocol, it is unclear whether other outcomes were assessed but not reported.

Other bias (outcomes appropriately analysed)

Low risk

Comment: it is unlikely that a unit of analysis error occurred as outcomes reported per person are reported as such (e.g. DASH, dexterity measures, satisfaction). Range of motion was calculated per digit. The authors disclosed funding for the project; however, it does not appear that this would have influenced the results in any way as it appears to have been from a non‐commercial granting agency. No further sources of risk of bias were identified.

Study characteristics

Methods

Study Design: randomised trial

Setting: single‐centre; Department of Plastic and Reconstructive Surgery of Nizam’s Institute of Medical Sciences, Hyderabad, India

Unit of randomisation: participant

Unit of analysis: unclear

Participants

Details of sampling frame:

Total eligible: 46 participants (digits: not reported)

Total excluded pre‐randomisation: 16 participants (digits: not reported)

Baseline characteristics:

Total randomised: 30 participants (digits: not reported)

Place and hold: 15 participants (digits: not reported)

Passive: 15 participants (digits: not reported)

Sex distribution: not reported

Age: not reported

Flexor tendon zone: zone V: 46 participants

Inclusion criteria:

• At least one flexor tendon injury in zone V

• 18 to 40 years of age

Exclusion criteria:

• nerve injuries

• extensor tendon injuries

• degenerative/rheumatoid arthritis

• fractures

• compression neuropathies

• neurological diseases involving the hand

Surgical technique for flexor tendon repair:

Not reported

Characteristics of participants lost to follow‐up/drop‐outs and included in analysis

Total lost to follow up/drop‐outs: 0 participants

Total available for 12‐week follow‐up: 30 participants (digits: not reported)

Total analysed: 30 participants (digits: not reported)

Interventions

Intervention 1: Early place and hold progressed to tendon gliding exercise regimen (multiple treatments)

Week 1 to 3: Place and hold exercise regimen

Components of the intervention: orthosis: dorsal blocking splint (wrist in 20° to 30°, MCP in 50° to 70°, IPJs in extension). Exercise regimen: within the orthosis: (1) active PIP and DIP joint extension; (2) isolated passive PIP and DIP flexion, followed by composite passive finger exercise; (3) place and hold exercise.

Dose: exercise regimen: (1) 50 repetitions; (2) 5 to 10 repetitions; (3) 2 to 5 repetitions

Frequency of administration: exercise regimen: hourly

Weeks 4 to 5: Graduated tendon gliding exercise regimen

Components of the intervention: orthosis: ceased early only if there is poor movement/scarring. Exercise regimen: (1) MCP joint blocked in flexion and gentle progressive IP joint extension; (2) FDS/FDP tendon gliding; (3) upgrade at five weeks to include non‐resistive blocking exercises

Dose: exercise regimen: not reported

Frequency of administration: exercise regimen: not reported

Week 6: Full passive stretching exercise regimen

Components of the intervention: orthosis: ceased. Exercise regimen: passive stretching exercise regimen for all joints

Dose: exercise regimen: not reported

Frequency of administration: exercise regimen: not reported

Intervention 2: Early passive progressed to active exercise regimen (multiple treatments)

Week 1 to 3: Passive exercise regimen

Components of the intervention: orthosis: dorsal blocking splint (wrist in 40 to 50 degrees, MCP 50 to 70 degrees, IPJs in extension). Exercise regimen: within the orthosis: passive exercise to all IP joints

Dose: exercise regimen: not reported

Frequency of administration: exercise regimen: hourly

Week 4 to 6: active exercise regimen

Components of the intervention: exercise regimen: active MCP and IP joint exercises

Dose: exercise regimen: not reported

Frequency of administration: exercise regimen: hourly

Both groups:

Components of the intervention: orthosis: each group received a dorsal blocking splint but at different wrist positions. Orthosis was discarded at four weeks unless there was excellent motion and in this case, orthosis was work for an additional 1 to 2 weeks. Exercise regimen: shoulder and elbow (no forearm) in all planes; (2) At week 4 ‐ active wrist exercises. Oedema reduction: elevation. Pain relief: TENS. Scar care: at week 3 (massage inside orthosis). Electrical stimulation: to promote tendon glide. Graded functional activity and strengthening regimen: commenced at week 6 and progressed to normal function by week 12.

Dose: orthosis: full time for six weeks. Exercise regimen: not reported. Oedema reduction: not reported. TENS: not reported. Scar care: not reported. Electrical stimulation: not reported. Graded functional activity: not reported.

Frequency of administration: orthosis: worn full time. Scar care: during therapy sessions (unknown frequency). Oedema reduction: not reported. TENS: not reported. Electrical stimulation: not reported. Graded functional activity and strengthening regimen: not reported.

NB: There is insufficient information in the publication to determine when the exercise regimen commenced during the first week post‐operation.

Outcomes

Outcomes were measured at 4 and 12 weeks:

• Active range of motion: TAM was measured using a goniometer. However, the goniometric measurements were not reported as means/SD. Instead, the data were used to calculate Strickland's classification for tendon repair outcomes

• Adverse events: tendon ruptures

• Strength: grip strength (Jamar dynamometer at 2nd setting) (at 12 weeks only)

• Outcomes measured but not of interest in this review: (1) active finger tip to DPC measure using a ruler (at 0 and 12 weeks); AROM at wrist using Goniometer (at 4 and 12 weeks).

Funding and conflicts of interest statements

Funding source: self‐funded
Conflicts of interest: none declared

Notes

Outcomes were reported as differences between the 12th week and baseline measures or 4th week and baseline for range of motion (TAM).

Participants contributed one or more tendons to the studies. The number of digits reported and the unit of analysis for each outcome is not reported. There is also insufficient information to determined the unit of analysis from the publication. A unit of analysis error may have occurred.

No clinical trials registration found.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: " Thirty subjects who fit the criteria were selected and randomly divided into two groups of 15 each by lottery method…"
Comment: the randomisation sequence appears to have been generated using an adequate method.

Allocation concealment (selection bias)

Unclear risk

Comment: there is insufficient information to determine how the random allocation sequence was concealed until the interventions were assigned. Clarification from the authors has been requested but was not received at the time of publication. Although a lottery method was used, it is unclear when the randomisation using this method occurred.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Quote: " Patients were blinded for being in either of the groups."
Comment: it appears that participants were blinded from which group they were in, but were aware they were receiving one of the interventions. Due to the nature of the intervention, treaters could not be blinded to the intervention. It is not known how successful the blinding of the participants was considering the treaters could not be blinded.

Blinding of outcome assessment (detection bias)
Objective outcomes

Unclear risk

Comment: it is not reported who conducted the outcome assessments and whether they were blinded to the participant's intervention assignment.

Incomplete outcome data (less than 3 months) (attrition bias)
All outcomes

Low risk

Quote: "No tendon ruptures or subject drop‐outs were recorded."

Comment: there was no attrition. Data were reported on a complete data set.

Selective reporting (reporting bias)

High risk

Comment: all outcomes described in the methods section of the paper are reported in the results section of the paper. No clinical trials registry was identified in the publication. Data are reported as the improvement from the first ROM measurement taken at week 1 to week 12, and then compared between groups. Baseline measurements are not reported nor does it state whether these were accounted for in the analysis. Mean and standard deviation scores for the different time points are not reported.

Other bias (outcomes appropriately analysed)

High risk

Comment: it is unclear whether a unit of analysis error may have occurred as the numbers of participants, hands and digits in each group included in the analysis are not reported. The authors had no conflicts of interest or funding sources. No further sources of bias detected. Outcomes were not appropriately analysed and were reported in a way that was not able to be interpreted in a meaningful way by the review authors.

Study characteristics

Methods

Study Design: parallel group randomised trial

Setting: France

Unit of randomisation: participant

Unit of analysis: unclear

Participants

Details of sampling frame:

Total eligible: not reported

Total excluded pre‐randomisation: not reported

Baseline characteristics:

Total randomised: 35 participants (digits: not reported)

Active group: 16 participants

Controlled passive group: 19 participants

Sex distribution: not reported

Age: mean: 35 years

Flexor tendon zone: zone II: 35 participants

Inclusion criteria:

• Flexor tendon laceration in zone II ‐ and surgery to repair flexor tendon. Planned hospital stay of at least six days.

Exclusion criteria:

• Vessels or nerve injury

• Soft tissue defects

• Fractures

Surgical technique:

Primary repair was performed as an emergency procedure using a 4/0 absorbable Tsuge core suture and a peripheral epitenon running suture (6/0 Prolene).

Characteristics of participants lost to follow‐up/drop‐outs and included in analysis

Total lost to follow up/drop‐outs: not reported

Total available for follow‐up: not reported

Total analysed: not reported

Interventions

Intervention 1: Early active flexion plus passive exercise regimen (Strickland and Small protocol)

Components of the intervention: exercise regimen: Passive flexion, active flexion and active extension within the orthosis using the Strickland exercise regimen. Authors cited these papers for their intervention protocol, Strickland 2000; Small 1989.

Dose: exercise regimen: not reported

Frequency of adminstration: exercise regimen: not reported

Intervention 2: Controlled passive exercise regimen (modified Kleinert protocol)

Components of the intervention: exercise regimen: controlled passive mobilisation using rubber band traction. Authors stated using the Kleinert protocol as referenced in Kleinert (Kleinert 1967).

Dose: exercise regimen: not reported

Frequency of administration: exercise regimen: not reported

Both groups:

Components of the intervention: rehabilitation started at three days post‐operation for both groups (other intervention components not reported).

Dose: exercise regimen: not reported

Frequency of administration: exercise regimen: not reported

Outcomes

Outcomes were measured at 8, 12 and 24 weeks:

• Active range of motion: active range of motion was measured at the PIP and DIP joints and was used to calculate the Strickland classification. They reported the percentage of patients achieving a total of excellent and good outcome (at 8, 12 and 24 weeks).

• Adverse events: tenolysis; DIPJ fusion; tendon grafts due to late ruptures

• Return to work: period out of work (average job inability) (15 were manual workers; 10 were students; 2 were unemployed).

• Other outcomes measured but not included in this review: fingertip to palm distance.

Funding and conflicts of interest statements

Funding source: not reported
Conflicts of interest: not reported

Notes

This was a conference proceeding. Hence, very little information was reported in the publication. No other publications of the trial were found. The authors were contacted to provide more information about the study methods and results, but no response from the authors was received.

Insufficient information is provided in the publication to determine whether or not a unit of analysis error may have occurred. However, very little data are included in the abstract.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "This prospective randomised study was designed to compare two methods of early mobilisation (Kleinert versus Strickland protocol) after primary repair of flexor tendons."

Comment: there is insufficient information in the publication to judge whether the allocation sequence was generated in a random manner.

Allocation concealment (selection bias)

Unclear risk

Quote: "This prospective randomised study was designed to compare two methods of early mobilisation (Kleinert versus Strickland protocol) after primary repair of flexor tendons."

Comment: there is insufficient information in the publication to judge whether the allocation sequence was adequately concealed prior to the randomisation.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Comment: given the nature of the interventions, participants were not blind to treatment, and may have had different expectations about the benefits of each intervention.

Blinding of outcome assessment (detection bias)
Objective outcomes

Unclear risk

Comment: it is not reported whether the outcome assessors were blinded to the intervention.

Incomplete outcome data (less than 3 months) (attrition bias)
All outcomes

Unclear risk

Comment: the participant flow was not reported and is unclear. It is unclear whether the number of participants reported were those that were randomised into the study and/or those available at follow‐up. Clarification from the authors has been requested but was not received at the time of publication.

Incomplete outcome data (3 to 6 months) (attrition bias)
All outcomes

Unclear risk

Comment: the participant flow was not reported and is unclear. It is unclear whether the number of participants reported were those that were randomised into the study and/or those available at follow‐up. Clarification from the authors has been requested but was not received at the time of publication.

Selective reporting (reporting bias)

High risk

Comment: the outcomes mentioned in the methods section are not fully reported in the results section of the conference abstract. Also, without a trial protocol, it is unclear whether other outcomes were assessed but not reported. Fingertip to palm distances and percentages of patients receiving fair or poor outcomes are not reported. Adverse events and mean duration for inability to work are reported for overall participants and not for the individual groups.

Other bias (outcomes appropriately analysed)

Unclear risk

Comment: very limited information is given in the conference abstract regarding the number of digits and tendons contributed to the study for each participant. The unit of analysis is unclear.