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Intervenciones conservadoras para el tratamiento de la fractura del tercio medio de la clavícula en adolescentes y adultos

Appendices

Appendix 1. Search strategies (Janurary 2014 to January 2016)

Cochrane Central Register of Studies (CRS Online)

#1 MESH DESCRIPTOR clavicle EXPLODE ALL TREES (66)
#2 (clavic* or midclavic* or collarbone):TI,AB,KY (225)
#3 #1 OR #2 (225)
#4 MESH DESCRIPTOR Fracture Healing (333)
#5 MESH DESCRIPTOR Fracture Fixation EXPLODE ALL TREES (1004)
#6 MESH DESCRIPTOR Fractures, Bone EXPLODE ALL TREES (3120)
#7 fracture*:TI,AB,KY (9958)
#8 #4 OR #5 OR #6 OR #7 (9974)
#9 #3 AND #8 (102)
#10 31/01/2014 TO 31/01/2016:DL (181817)
#11 #9 AND #10 (50)

MEDLINE (OvidSP)

1 Clavicle/ (4763)
2 (clavic* or midclavic* or collarbone).tw. (8153)
3 1 or 2 (9807)
4 Fracture Healing/ (10158)
5 exp Fracture Fixation/ (49809)
6 exp Fractures, Bone/ (149256)
7 fracture*.tw. (191373)
8 4 or 5 or 6 or 7 (237311)
9 3 and 8 (2997)
10 Randomized controlled trial.pt. (422103)
11 Controlled clinical trial.pt. (92600)
12 randomized.ab. (344099)
13 placebo.ab. (171790)
14 Drug therapy.fs. (1876199)
15 randomly.ab. (247903)
16 trial.ab. (359106)
17 groups.ab. (1540591)
18 or/10‐17 (3746261)
19 exp Animals/ not Humans/ (4176097)
20 18 not 19 (3223958)
21 9 and 20 (331)

Embase (Ovid Online)

1 Clavicle/ (5030)
2 (clavic* or midclavic* or collarbone).tw. (9473)
3 or/1‐2 (10957)
4 exp Fracture Healing/ or exp Fracture Treatment/ or exp Fracture/ (246703)
5 fracture*.tw. (219328)
6 or/4‐5 (306053)
7 and/3,6 (3289)
8 Randomized Controlled Trial/ (388340)
9 Controlled Clinical Study/ (391120)
10 random*.ti,ab. (1029619)
11 Randomization/ (68588)
12 Intermethod Comparison/ (203346)
13 placebo.ti,ab. (223165)
14 (compare or compared or comparison).ti. (387195)
15 ((evaluated or evaluate or evaluating or assessed or assess) and (compare or compared or comparing or comparison)).ab. (1315917)
16 (open adj label).ti,ab. (47583)
17 ((double or single or doubly or singly) adj (blind or blinded or blindly)).ti,ab. (171854)
18 Double Blind Procedure/ (124856)
19 parallel group*1.ti,ab. (17424)
20 (crossover or cross over).ti,ab. (75833)
21 ((assign* or match or matched or allocation) adj5 (alternate or group*1 or intervention*1 or patient*1 or subject*1 or participant*1)).ti,ab. (221526)
22 (assigned or allocated).ti,ab. (263126)
23 (controlled adj7 (study or design or trial)).ti,ab. (228125)
24 (volunteer or volunteers).ti,ab. (187553)
25 Human Experiment/ (345374)
26 trial.ti. (189895)
27 or/8‐26 (3415088)
28 (exp Animal/ or Animal.hw. or Nonhuman/) not (exp Human/ or Human Cell/ or (human or humans).ti.) (5397275)
29 27 not 28 (2962221)
30 7 and 29 (461)
31 (2014* or 2015* or 2016*).em,dd. (3508884)
32 30 and 31 (136)

LILACS (BIREME)

Mh Clavicle OR Tw clavic$ OR Tw midclavic$ OR Tw collarbone [Words] and Mh Fracture healing OR Mh Fracture fixation OR Mh Fractures OR Tw fracture$ [Words] and ((Pt randomized controlled trial OR Pt controlled clinical trial OR Mh Randomized controlled trials OR Mh Random allocation OR Mh Double‐blind method OR Mh Single‐blind method) AND NOT (Ct animals AND NOT (Ct human and Ct animal)) OR (Pt clinical trial OR Ex E05.318.760.535$ OR (Tw clin$ AND (Tw trial$ OR Tw ensa$ OR Tw estud$ OR Tw experim$ OR Tw investiga$)) OR ((Tw singl$ OR Tw simple$ OR Tw doubl$ OR Tw doble$ OR Tw duplo$ OR Tw trebl$ OR Tw trip$) AND (Tw blind$ OR Tw cego$ OR Tw ciego$ OR Tw mask$ OR Tw mascar$)) OR Mh placebos OR Tw placebo$ OR (Tw random$ OR Tw randon$ OR Tw casual$ OR Tw acaso$ OR Tw azar OR Tw aleator$) OR Mh Research design) AND NOT (Ct animals AND NOT (Ct human and Ct animals)) OR (Ct comparative study OR Ex E05.337$ OR Mh Follow‐up studies OR Mh Prospective studies OR Tw control$ OR Tw prospectiv$ OR Tw volunt$ OR Tw volunteer$) AND NOT (Ct animals AND NOT (Ct human and Ct animals))) [Words] (20)

Orthopaedic Proceedings (The Bone and Joint Journal)

Title: clavic* or midclavic* or collarbone

Abstract or title: random*

Orthopaedic Proceedings = 14

ISRCTN Registry

fracture AND (clavicle OR clavicular OR midclavicle OR midclavicular) = 9

WHO International Clinical Trials Registry Platform

clavic* AND fracture* OR midclavic* AND fracture* OR mid‐clavic* AND fracture* = 40

ClinicalTrials.gov

fracture AND (clavicle OR clavicular OR midclavicle OR midclavicular) = 31

Appendix 2. Previous search strategies 2008 to 2014

The Cochrane Library (Wiley Online Library)

#1 MeSH descriptor: [Clavicle] this term only (75)
#2 (clavic* or midclavic* or collarbone):ti,ab,kw (159)
#3 (#1 or #2) (159)
#4 MeSH descriptor: [Fracture Healing] this term only (364)
#5 MeSH descriptor: [Fracture Fixation] explode all trees (1124)
#6 MeSH descriptor: [Fractures, Bone] explode all trees (3803)
#7 (fracture*):ti,ab,kw (8448)
#8 (#4 or #5 or #6 or #7) (8464)
#9 (#3 and #8) in Trials (54)

MEDLINE (PubMed)

(((Clavicle [mh] OR clavic* [tw] OR collarbone [tw]) AND (Fracture Healing [mh] OR Fracture Fixation [mh] OR Fractures, Bone [mh] OR fracture* [tw]) AND (randomized controlled trial [pt] OR controlled clinical trial [pt] OR randomized controlled trials [mh] OR random allocation [mh] OR double‐blind method [mh] OR single‐blind method [mh] OR clinical trial [pt] OR clinical trials [mh] OR ("clinical trial" [tw]) OR ((singl* [tw] OR doubl* [tw] OR trebl* [tw] OR tripl* [tw]) AND (mask* [tw] OR blind* [tw])) OR (placebos [mh] OR placebo* [tw] OR random* [tw] OR research design [mh:noexp]) NOT (animals [mh] NOT humans [mh])))) AND 2008:2014 [edat] (89)

Embase (Ovid Online)

1 Clavicle/ (4726)
2 (clavic$ or midclavic$ or collarbone).tw. (9091)
3 or/1‐2 (10567)
4 exp Fracture Healing/ or exp Fracture Treatment/ or exp Fracture/ (232404)
5 fracture$.tw. (209206)
6 or/4‐5 (291855)
7 and/3,6 (3094)
8 Clinical trial/ (896067)
9 Randomized controlled trial/ (367792)
10 Randomization/ (64730)
11 Single blind procedure/ (18891)
12 Double blind procedure/ (122402)
13 Crossover procedure/ (39662)
14 Placebo/ (245995)
15 Randomi?ed controlled trial$.tw. (99640)
16 Rct.tw. (13563)
17 Random allocation.tw. (1368)
18 Randomly allocated.tw. (20584)
19 Allocated randomly.tw. (1974)
20 (allocated adj2 random).tw. (823)
21 Single blind$.tw. (14643)
22 Double blind$.tw. (150221)
23 ((treble or triple) adj blind$).tw. (377)
24 Placebo$.tw. (206316)
25 Prospective study/ (261999)
26 or/8‐25 (1429455)
27 Case study/ (23741)
28 Case report.tw. (270245)
29 Abstract report/ or Letter/ (920220)
30 or/27‐29 (1208582)
31 26 not 30 (1391203)
32 limit 31 to human (1265124)
33 and/7,32 (181)
34 (2008$ or 2009$ or 2010$ or 2011$ or 2012$ or 2013$ or 2014$).em. (7323623)
35 33 and 34 (108)

LILACS (BIREME)

Mh Clavicle OR Tw clavic$ OR Tw midclavic$ OR Tw collarbone [Words] and Mh Fracture healing OR Mh Fracture fixation OR Mh Fractures OR Tw fracture$ [Words] and ((Pt randomized controlled trial OR Pt controlled clinical trial OR Mh Randomized controlled trials OR Mh Random allocation OR Mh Double‐blind method OR Mh Single‐blind method) AND NOT (Ct animals AND NOT (Ct human and Ct animal)) OR (Pt clinical trial OR Ex E05.318.760.535$ OR (Tw clin$ AND (Tw trial$ OR Tw ensa$ OR Tw estud$ OR Tw experim$ OR Tw investiga$)) OR ((Tw singl$ OR Tw simple$ OR Tw doubl$ OR Tw doble$ OR Tw duplo$ OR Tw trebl$ OR Tw trip$) AND (Tw blind$ OR Tw cego$ OR Tw ciego$ OR Tw mask$ OR Tw mascar$)) OR Mh placebos OR Tw placebo$ OR (Tw random$ OR Tw randon$ OR Tw casual$ OR Tw acaso$ OR Tw azar OR Tw aleator$) OR Mh Research design) AND NOT (Ct animals AND NOT (Ct human and Ct animals)) OR (Ct comparative study OR Ex E05.337$ OR Mh Follow‐up studies OR Mh Prospective studies OR Tw control$ OR Tw prospectiv$ OR Tw volunt$ OR Tw volunteer$) AND NOT (Ct animals AND NOT (Ct human and Ct animals))) [Words] (18)

Orthopaedic Proceedings (The Bone and Joint Journal)

Title: clavic* or midclavic* or collarbone

Abstract or title: random*

Orthopaedic Proceedings = 13

Appendix 3. Results of the searches in previous versions of the review

Lenza 2014

We updated the search from December 2008 to January 2014. We screened a total of 282 records from the following databases: Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (0), the Cochrane Central Register of Controlled Trials (54), MEDLINE (89), Embase (108), LILACS (18) and Orthopaedic Proceedings (13). We did not identify any potentially eligible studies from trial registers or other sources.

The search update resulted in the identification of one potentially eligible study, for which we obtained a full report. We excluded this study (Bajuri 2011). We also excluded one study that was classified as ongoing in the last version of this review, after contact with the primary study author (Roberti 2008). A flow diagram summarising the study selection process is shown in Figure 1.

Overall, there are now a total of three included studies, four excluded studies, no ongoing trials and no studies awaiting classification.

Lenza 2009a

The search of five main electronic databases for completed research yielded 159 references (Figure 1). JB and ML screened the titles and abstracts for references and firstly excluded 152 citations. Among these, 115 were duplicated citations or not relevant, 31 were excluded because they did not meet the inclusion criteria for participants or interventions, and six were not randomised or quasi‐randomised trials. The remaining seven potentially relevant studies were evaluated from full trial reports. Three trials were included (Andersen 1987a; Hoofwijk 1988; Lubbert 2008). A translation of one report (Jensen 1985) showed it that was a report of Andersen 1987a. One full report and two abstracts, one of which reported interim results (Hoofwijk 1986), were available for Hoofwijk 1988. Finally, one study (Thompson 2005) was excluded. Two trials were translated to English (see Acknowledgements). Of the two further trials identified from Trial Registers, one was excluded (Talbot 2008) and one is ongoing (Roberti 2008a).

Study flow diagram
Figuras y tablas -
Figure 1

Study flow diagram

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
Figuras y tablas -
Figure 2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study
Figuras y tablas -
Figure 3

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 1 Shoulder function.
Figuras y tablas -
Analysis 1.1

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 1 Shoulder function.

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 2 Shoulder function: number of participants with 'good function'.
Figuras y tablas -
Analysis 1.2

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 2 Shoulder function: number of participants with 'good function'.

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 3 Pain: visual analogue scale (0 (no pain) to 10 (worst pain)).
Figuras y tablas -
Analysis 1.3

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 3 Pain: visual analogue scale (0 (no pain) to 10 (worst pain)).

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 4 Pain: duration of painkiller consumption (days).
Figuras y tablas -
Analysis 1.4

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 4 Pain: duration of painkiller consumption (days).

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 5 Clinical healing: time to clinical fracture consolidation (weeks).
Figuras y tablas -
Analysis 1.5

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 5 Clinical healing: time to clinical fracture consolidation (weeks).

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 6 Adverse event.
Figuras y tablas -
Analysis 1.6

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 6 Adverse event.

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 7 Time to return to previous activities (weeks).
Figuras y tablas -
Analysis 1.7

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 7 Time to return to previous activities (weeks).

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 8 Patient dissatisfaction with course of treatment.
Figuras y tablas -
Analysis 1.8

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 8 Patient dissatisfaction with course of treatment.

Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 1 Pain: visual analogue scale (0 (no pain) to 10 (worst pain)).
Figuras y tablas -
Analysis 2.1

Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 1 Pain: visual analogue scale (0 (no pain) to 10 (worst pain)).

Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 2 Pain: number of painkillers (tablets/28 days).
Figuras y tablas -
Analysis 2.2

Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 2 Pain: number of painkillers (tablets/28 days).

Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 3 Treatment failure.
Figuras y tablas -
Analysis 2.3

Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 3 Treatment failure.

Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 4 Clinical healing: time to clinical fracture consolidation (days).
Figuras y tablas -
Analysis 2.4

Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 4 Clinical healing: time to clinical fracture consolidation (days).

Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 5 Adverse events: skin irritation.
Figuras y tablas -
Analysis 2.5

Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 5 Adverse events: skin irritation.

Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 6 Time to return to previous activities (days).
Figuras y tablas -
Analysis 2.6

Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 6 Time to return to previous activities (days).

Summary of findings for the main comparison. Summary of findings: figure‐of‐eight bandage versus arm sling

Figure‐of‐eight bandage compared with arm sling for treating fractures of the middle third of the clavicle

Patient or population: patients (mainly young male adults) with fractures of the middle third of the clavicle

Settings: hospital (initially)

Intervention: figure‐of‐eight bandage

Comparison: arm sling

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Arm sling

Figure‐of‐eight bandage

Shoulder function

Constant score (0 to 100 points: higher = better)

Follow‐up: 6 to 12 months

Mean (SD) population Constant score 89 (7)¹

Mean function in the figure‐of‐eight bandage groups was 0.75 points lower (3.72 lower to 2.39 higher)

MD ‐0.75 points (‐3.72 to 2.39)

51
(1 study)

⊕⊝⊝⊝
very low²

The 95% CI does not include a clinically important difference.³

Shoulder function was measured using non‐validated measures in two other trials (61 and 152 participants). Both trials found evidence of similar shoulder function in the two groups

Pain (early)

Visual Analogue Scale ‐ VAS (0 (no pain) to 10 (worst pain))

Follow‐up: 2 weeks

Mean pain in the arm sling groups ranged from
0.9 to 1.8 points

Mean pain in the figure‐of‐eight bandage groups was 0.43 points higher (0.35 lower to 1.21 higher)

MD 0.43 points (‐0.35 to 1.21)

203 (2 studies)

⊕⊝⊝⊝
very low

The 95% CI do not include a clinically important difference.

A third trial (data for 61 participants) provided very low quality evidence based on a non‐validated scoring system of more pain and discomfort during the course of treatment in the figure‐of‐eight group

Treatment failure

(Number of participants who have undergone or are being considered for a surgical intervention)

See comment

See comment

Not estimable

See comment

Poorly reported outcome. One trial (152 participants) reported that one participant in the arm sling group had successful surgery for a secondary plexus nerve palsy

Clinical healing ‐ time to clinical fracture consolidation (weeks)

Mean clinical healing in the arm sling group was 3.6 weeks

Mean clinical healing in the figure‐of‐eight bandage group was 0.20 weeks longer (0.11 week shorter to 0.51 week longer)

MD 0.20 weeks (‐0.11 to 0.51)

148
(1 study)

⊕⊝⊝⊝
very low²

In addition, there were four non‐unions in the figure‐of‐eight group; none were problematic

Adverse events ‐ total participants

with adverse events

See comment

See comment

Not estimable

See comment

The very low evidence quality data for individual adverse outcomes (poor cosmetic appearance; change in allocated treatment due to pain and discomfort, worsened fracture position on healing; shortening > 15 mm; non‐symptomatic non‐union and permanent pain) did not confirm a difference between the two groups⁵

Quality of life

See comment

See comment

Not estimable

See comment

Not measured in any trial

Return to previous activities ‐ Resumption of school/work (weeks)

Mean time to return to previous activities ranged across control groups from
3.5 to 4.6 weeks

Mean time to return to previous activities (weeks) ‐ resumption of school/work in the intervention groups was 0.12 weeks lower (0.69 lower to 0.45 higher)

MD ‐0.12 weeks (‐0.69 to 0.45)

176 (2 studies)

⊕⊝⊝⊝
very low

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; MD: mean difference; RR: risk ratio SMD: standardised mean difference; VAS: visual analogue scale.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

¹ These are based on the Constant score in healthy people as reported in Yian 2005.

² We downgraded the evidence for this outcome two levels for high risk of bias reflecting serious study limitations, which included inadequately concealed treatment allocation and lack of blinding. We downgraded the evidence one further level for imprecision given the wide confidence interval and that the available data were from only one trial.

³ For the purposes of this review, the minimally clinical important difference was considered to be 10 points for the Constant score (Kukkonen 2013).

⁴ We downgraded the evidence for this outcome two levels for high risk of bias reflecting serious study limitations, which included inadequately concealed treatment allocation and lack of assessor blinding. We downgraded the evidence one further level for inconsistency given the considerable heterogeneity between the findings of the two groups (I² = 74%).

⁵ Data for individual adverse outcomes (poor cosmetic appearance; change in allocated treatment due to pain and discomfort, worsened fracture position on healing; shortening > 15 mm; non‐symptomatic non‐union and permanent pain) confirmed a difference between the two groups.

⁶ We downgraded the evidence for this outcome two levels for high risk of bias reflecting serious study limitations, which included inadequately concealed treatment allocation and lack of assessor blinding. We downgraded the evidence one further level for imprecision given the low numbers of participants contributing data to this outcome.

Figuras y tablas -
Summary of findings for the main comparison. Summary of findings: figure‐of‐eight bandage versus arm sling
Summary of findings 2. Summary of findings: low‐intensity pulsed ultrasound

Low‐intensity pulsed ultrasound compared with placebo for treating fractures of the middle third of the clavicle

Patient or population: patients with fractures of the middle third of the clavicle

Settings: hospital

Intervention: low‐intensity pulsed ultrasound

Comparison: placebo

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Placebo

Low‐intensity pulsed ultrasound

Shoulder function

See comment

See comment

Not estimable

See comment

Not measured in the trial

Pain

Visual analogue scale ‐ VAS (0 (no pain) to 10 (worst pain))

Follow‐up: in the 28‐day treatment period

Mean pain in the control group was
3.55 points

Mean pain in the intervention group was 0.04 points lower (0.61 lower to 0.53 higher)

MD ‐0.04 (95% CI ‐0.61 to 0.53)

101 (1 study)

⊕⊕⊕⊝
moderate¹

Treatment failure ‐ Number who had surgical procedure

See comment

See comment

RR 1.13 (0.37 to 3.47)

101 (1 study)

⊕⊕⊕⊝
moderate¹

Only one trial assessed this comparison

Clinical healing ‐ Time to clinical fracture consolidation (days)

Mean clinical healing in the control group was 27.09 days

Mean clinical healing: time to clinical/radiographic fracture consolidation (days) in the intervention group was 0.32 days lower (5.85 lower to 5.21 higher)

MD ‐0.32 weeks (‐5.85 to 5.21)

101 (1 study)

⊕⊕⊕⊝
moderate¹

Adverse events ‐ total of adverse events

(Skin irritation)

Follow‐up: during the intervention

See comment

See comment

RR 0.94 (0.06 to 14.65)

101 (1 study)

⊕⊕⊕⊝
moderate¹

Only one trial assessed this comparison

Quality of life

See comment

See comment

Not estimable

See comment

Not measured in the trial

Return to previous activities ‐ Resumption of work (days)

Mean time to return to previous activities in the control group was
15.05 days

Mean time to return to previous activities (days) ‐ resumption of work in the intervention group was 1.95 weeks higher (2.18 lower to 6.08 higher)

MD 1.95 days (‐2.18 to 6.08)

101 (1 study)

⊕⊕⊕⊝
moderate¹

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; MD: mean difference; RR: risk ratio; VAS: visual analogue scale.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

¹ We downgraded the evidence one level for imprecision given the wide confidence interval and that the available data were from only one trial.

Figuras y tablas -
Summary of findings 2. Summary of findings: low‐intensity pulsed ultrasound
Comparison 1. Figure‐of‐eight bandage versus arm sling

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Shoulder function Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1.1 Constant score (at end of follow‐up: 6 ‐ 12 months)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 ASES score (at end of follow‐up: 6 ‐ 12 months)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Shoulder function: number of participants with 'good function' Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3 Pain: visual analogue scale (0 (no pain) to 10 (worst pain)) Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 Pain on 1st day

2

203

Mean Difference (IV, Random, 95% CI)

0.63 [‐0.57, 1.83]

3.2 Pain on 1st week

2

203

Mean Difference (IV, Random, 95% CI)

0.20 [‐0.32, 0.73]

3.3 Pain on 2nd week

2

203

Mean Difference (IV, Random, 95% CI)

0.43 [‐0.35, 1.21]

3.4 Pain on 3rd week

1

51

Mean Difference (IV, Random, 95% CI)

0.10 [‐0.21, 0.41]

4 Pain: duration of painkiller consumption (days) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5 Clinical healing: time to clinical fracture consolidation (weeks) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

6 Adverse event Show forest plot

3

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

6.1 Poor cosmetic appearance post fracture healing

1

152

Risk Ratio (M‐H, Fixed, 95% CI)

1.32 [0.55, 3.16]

6.2 Change in allocated treatment due to pain and discomfort

1

79

Risk Ratio (M‐H, Fixed, 95% CI)

3.02 [0.35, 25.83]

6.3 Worsened fracture position on healing

1

61

Risk Ratio (M‐H, Fixed, 95% CI)

0.60 [0.15, 2.44]

6.4 Shortening > 15 mm

1

51

Risk Ratio (M‐H, Fixed, 95% CI)

1.01 [0.35, 2.90]

6.5 Non‐union

3

264

Risk Ratio (M‐H, Fixed, 95% CI)

9.48 [0.52, 173.09]

6.6 Permanent pain at mean 10 months

1

152

Risk Ratio (M‐H, Fixed, 95% CI)

9.48 [0.52, 173.09]

7 Time to return to previous activities (weeks) Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

7.1 Resumption of school/work

2

176

Mean Difference (IV, Fixed, 95% CI)

‐0.12 [‐0.69, 0.45]

7.2 Resumption of sports activities

1

104

Mean Difference (IV, Fixed, 95% CI)

‐0.60 [‐1.48, 0.28]

8 Patient dissatisfaction with course of treatment Show forest plot

2

112

Risk Ratio (M‐H, Fixed, 95% CI)

2.73 [1.03, 7.23]

Figuras y tablas -
Comparison 1. Figure‐of‐eight bandage versus arm sling
Comparison 2. Low‐intensity pulsed ultrasound versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain: visual analogue scale (0 (no pain) to 10 (worst pain)) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

2 Pain: number of painkillers (tablets/28 days) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

3 Treatment failure Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3.1 Number who had surgical procedure

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Clinical healing: time to clinical fracture consolidation (days) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5 Adverse events: skin irritation Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

6 Time to return to previous activities (days) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

6.1 Resumption of household activities

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.2 Resumption of professional work

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.3 Resumption of sport

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 2. Low‐intensity pulsed ultrasound versus placebo