Methods

Randomised controlled trial.
Randomisation method not described
Blinding: outcome assessment was blinded but participants were not.
Loss to follow‐up: zero
Sample size calculation: not reported
Appropriate statistical analysis: yes, intention to treat analysis.

Participants

40 participants, 24 females and 16 males
Inclusion criteria: painful stiff shoulders of at least 1 month's duration; pain with sleep disturbance; restricted active and passive shoulder movement with a reduction in external rotation of at least 50%
Exclusion criteria: generalised arthritis; sensory symptoms or signs in the arm; radiation of pain to the neck; peptic ulceration; serious infection; contraindications to systemic steroid therapy.

Interventions

Group 1(20 participants): 10mg enteric coated prednisolone as a morning dose for 4 weeks, then 5mg per day for 2 weeks.
Group 2 (20 participants): No treatment
All participants in both groups were taught home pendular exercises and advised to do them for 2‐3 minutes every hour. Nonsalicylate analgesics and diazepam 5 mg at night were available if requested but NSAIDs were stopped.

Outcomes

Assessed at baseline, 2, 4, 6 weeks and monthly for a further 6 months.
1) Pain at night, pain on movement and pain at rest during the day on 10cm VAS
2) Passive movements were measured using a hydrogoniometer
a. Total flexion (TF)
b. Glenohumeral flexion (GF)
c. Total abduction (TA)
d. Glenohumeral abduction (GA)
e. Total rotation (TR)
f. External rotation (ER)
Calculated a "principal component" (C) from these measures = (0.506 x TF) + (0.215 x GF) + (0.583 x TA) + (0.253 x GA) + (0.124 x ER) + (0.528 x TR) ‐ 163.39.

Notes

Pain was measured on visual analogue scales (VAS) but reported as number of participants with residual pain at 8 months.
Only means and range of movement at 8 months was reported (authors report that baseline measurements were comparable between groups).
Number of participants with residual pain at 8 months and range of movement at 8 months was able to be used for meta‐analysis (by computing standard deviations from mean and range scores by assuming standard deviation equals one quarter of the range). All other data was presented graphically, without any measures of variance and therefore could not be used for meta‐analysis. Authors reported that the pattern of improvement in pain at night over 8 weeks showed a significant difference in favour of the oral steroid group with a more rapid initial recovery, although by 5 months the difference between groups was negligible. Improvements in pain at rest and with movement, range of motion and a cumulative recovery curve were not significantly different between groups over 8 months. No external funding acknowledgements listed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomised controlled trial.
Randomisation: allocated to treatment on the basis of a pre‐arranged random order stratified for duration of symptoms more than or less than 6 months. The treatment register was held by the hospital pharmacist, and the 2 surgeons admitting participants to the trial and assessing their progress did not know which participants were receiving cortisone until after the whole trial had been completed.
Blinding: both participants and outcome assessors were blinded.
Loss to follow‐up: 2 (12.5%) patients from cortisone group: a 69 year old man who died suddenly from coronary occlusion during the third week of treatment and a 53 year old woman who developed follicular dermatitis during the fourth week of treatment and was withdrawn. Sample size calculation: not reported
Appropriate statistical analysis: yes, intention to treat analysis.

Participants

32 participants
Inclusion criteria: Periarthritis of one or both shoulders; aged between 20 and 70yrs old; no symptoms or signs of disease in other joints; no evidence of arthritis or bone diseases on x‐ray; blood sedimentation rate (Wintrobe) under 20mm in first hour; chest x‐rays within normal limits.
Exclusion criteria: inflammatory conditions; coronary disease

Interventions

Group 1(16 participants): cortisone acetate suspension in syrup (concentration = 12.5mg/ml) taken orally in four divided doses during the day. 200mg for 1st 3 days, and 100mg thereafter till 14th day. The daily dose was then tailed off in decrements in 12.5mg every 2 days. The complete dosage for four weeks = 2.5g
Group 2 (16 participants): placebo inert suspension in similar dosage.
All participants in both groups were instructed to exercise their shoulders vigourously. At end of 4 weeks, the participants who had not progressed satisfactorily had their shoulders manipulated under general anaesthesia. This manipulation was followed by a 2nd four‐weeks course of cortisone or placebo. All cases followed for 18 weeks.

Outcomes

Assessed at baseline, 1, 4, 5, 8 and 18 weeks
1) Spontaneous pain
2) Pain on movement
(Both measured by 0=none, 1=slight, 2=moderate, 3=severe)
3) Total abduction (degrees)
4) Glenohumeral abduction (degrees)
5) Rotation at shoulder joint (degrees).

Notes

Only mean data without any measures of variance were reported and therefore data could not be used for meta‐analysis. 4‐point categorical scale analysed as interval scale. The authors reported that there was no statistically significant difference between the two groups however there was a suggestion that improvement in pain and range of movement occurred earlier in the steroid treated group (see Additional Tables 1 and 2). Steroid therapy also reduced the number of patients requiring manipulation at the end of 4 weeks (11/16 (68.8%) in the control group vs 6/15 (40%) in the steroid group) for failure to improve (not statistically significant). There was one death due to coronary occlusion during the third week of treatment and one participant developed follicular dermatitis in the fourth week of treatment. Both participants were in the oral steroid group. No external funding acknowledgements listed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomised controlled trial
Randomisation: computer generated permuted block randomisation of eight. Allocation concealment ensured and study biostatistician kept assignment scheme.
Blinding: both participants and outcome assessors were blinded.
Loss to follow‐up: No patients prior to 3 week follow up , although 1 was lost to follow up at 6 weeks and 3 were lost to follow up at 12 weeks.
Sample size reported: yes. Sample size: 21 participants per group would have 90% power at a significance level of 0.05 to detect a clinically important difference in pain perception of two (on 0 to 10 scale) assuming standard deviation is 2.
Appropriate statistical analysis: yes, intention to treat analysis

Participants

49 participants
Inclusion criteria: pain and stiffness in predominantly one shoulder for greater than or equal to 3 weeks; restriction of passive motion of greater than 30 degrees in two or more planes of movement measured to onset of pain with a gravity inclinometer; adults > 18 years.
Exclusion criteria: systemic inflammatory joint disease (including rheumatoid arthritis, polymyalgia rheumatica); oral steroids in previous 3 months; diabetes mellitus (because of potential for unblinding); pregnancy; contraindications to oral steroids including peptic ulceration; serious infection or uncontrolled hypertension; radiological evidence of osteoarthritis of the shoulder or fracture; calcification about the shoulder joint; reason to suspect a full rotator cuff tear (weakness of arm elevation, a positive "drop arm sign", a high riding humerus visible on x‐ray of the shoulder or demonstration of a complete rotator cuff tear on ultrasound); likely not to comply with follow up (e.g.: living too far away to attend for follow up assessment and/or those indicating they would be unable and/or unwilling to attend for outcome assessment); lack of written informed consent.

Interventions

Group 1 (oral prednisolone group) (24 participants): 6 x 5mg tablets or oral prednisolone daily for 3 weeks as a single morning dose.
Group 2 (placebo group) (26 participants): 6 x 5mg placebo tablets (identical in taste and appearance to the prednisolone tablets) daily for 3 weeks as a single morning dose.
Participants in both groups received a simple exercise program comprising pendular exercises and scapular setting (isometric scapular retraction). Participants were asked to cease non‐steroidal anti‐inflammatory medication but were allowed paracetamol and codeine preparations. No other interventions were allowed for the duration of the trial. For ethical reasons, if the patients had not improved after 6 weeks, the treating physician could request an unblinding of treatment allocation and further manage the condition at their discretion. This was considered a protocol violation but the participant continued to be followed up and the outcome assessor remained blinded.

Outcomes

Outcome assessed at baseline, 3, 6 and 12 weeks.
Primary outcome measure was overall pain perception at 3 weeks.
1) Pain perception: overall pain, night pain, activity related pain on vertical Likert scale from 0‐10 where 0 = no pain and 10 = maximal imaginable pain.
2) Shoulder Pain and Disability Index (SPADI): 13 items divided into 2 subscales (pain ‐ 5 items and disability ‐ 8 items). Score out of 100 where higher scores reflect more pain/disability.
3) Croft shoulder disability questionnaire: score out of 22 where a higher score reflects more disability.
4) Disabilities Arm Shoulder and Hand (DASH) questionnaire: Score expressed as a percentage score (0‐100).
5) Health Assessment Questionnaire (HAQ): arthritis‐specific functional assessment measure. The disability score is expressed between 0 (no disability) and 3 (highest disability).
6) Short Form 36 Health Survey (SF‐36): self‐administered 36 item generic indicator of health status consisting of 8 subscales. Each of the 8 subscales is rescaled from 0‐100 where higher scores represent better health.
7) Participant‐rated improvement compared to baseline on a 5‐point categorical scale (marked improvement, moderate improvement, same, moderate worsening, marked worsening). Success was defined a priori as marked or moderate improvement.
8) Range of motion: total shoulder flexion, total shoulder abduction and external glenohumeral rotation in neutral abduction were measured using an inclinometer and hand behind back was measured by assessment of the anatomical landmark reached by extended thumb.
9) Adverse effects.

Notes

Sigma pharmaceuticals provided the prednisolone tablets at no cost. No other external funding acknowledgements listed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomised controlled trial.
Randomisation: allocated by randomized selection to one of two groups, method not described.
Blinding: Both participants and medical staff concerned with treatment blinded (presumed to have performed outcome assessments).
Loss to follow up: 5 (15.6%) patients were excluded from the analysis on the basis of insufficient information.
Sample size calculation: not reported
Appropriate statistical analysis: unclear

Participants

30 participants (5 excluded = 27 patients, 28 shoulders (one patient sequential bilateral involvement during 3 years of trial so included twice)
Inclusion criteria: Spontaneous onset of pain localized to the shoulder region with the pain increasing in severity and usually being worse at night; limitation of all total shoulder movements by at least 50%; no clinically or radiologically identifiable lesion of the shoulder.

Interventions

Group 1 (14 patients): prednisone 5 mg three times daily for 2 weeks prior to manipulation and 2 weeks thereafter in diminishing doses.
Group 2 (16 patients): identical placebo.
Both groups had 2 weeks' rest in sling followed by manipulation under anaesthesia combined with injection of hydrocortisone acetate 25 mg and 0.5% bupivacaine 10 ml into the glenohumeral joint. Following manipulation all patients received supervised physiotherapy consisting of graded exercises.

Outcomes

1) "dramatic response to manipulation" (audible cracking of adhesions and full range of motion obtained under anaesthesia)‐ measured at manipulation under anaesthesia
2) shoulder movements ‐ reported for external rotation and elevation in flexion, expressed as a percentage of normal as judged by the opposite shoulder, (percentage of participants with better than three‐quarter normal movements compared with the normal shoulder); data presented for 6, 12 and 18 weeks post‐manipulation.

Notes

The timing of the outcome assessments was unclear but data was presented for 6, 12 and 18 weeks post manipulation. The method of data analysis was also unclear. The authors reported shoulder movements as percentage at each time point with better than 3/4 normal movements compared with the unaffected shoulder; we converted this to proportion of participants with better than 3/4 normal shoulder movement compared with the unaffected shoulder.
No adverse events listed
No external funding acknowledgements listed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomised controlled trial.
Randomisation: participants allocated into two groups using random number tables to generate a random sequence; numbered, sealed envelopes containing the treatment allocation were prepared prior to the trial. It is not explicitly stated however, if the allocation was concealed from investigators and participants.
Blinding: outcome assessors were blinded to treatment allocation.
Losses to follow‐up: one drop‐out reported, from the oral steroid group.
Sample size calculation: not reported.
Appropriate statistical analysis: insufficient data reported to determine if intention to treat analysis was performed.

Participants

28 participants included, appears 37 were screened for inclusion.
Inclusion criteria: new, not previously treated episode of frozen shoulder syndrome or adhesive capsulitis; defined as painful limited, passive glenohumeral mobility, external rotation <30 degrees, abduction <90 degrees and in stage 2 or 3 of the disease process; stage 2: external rotation between 20 to 30 degrees and abduction between 60 degrees to 90 degrees; stage 3: external rotation less than or equal to 20 degrees and abduction less than or equal to 60 degrees; age 40 years or over.
Exclusion criteria: contraindications to oral or intra‐articular injection of corticosteroids, insulin‐dependent diabetes mellitus, neurological disorders, cervical spondylosis, previous fracture or surgery or dislocation of the shoulder area, severe gastric complaints.

Interventions

Group 1 (15 participants): oral corticosteroid treatment, triamcinolone 4mg tablets, taken orally 3 times per day for 1 week, then two times per day for 1 week, then once per day for 1 week.
Group 2 (13 participants): intra‐articular corticosteroid injection of 40mg triamcinolone acetonide using the posterior route
Participants in both groups had physiotherapy from day 4 of 12 sessions of 20 minutes each, consisting of active exercise and passive joint mobilization. Participants could use ice or hot packs, but no other forms of treatment were allowed.

Outcomes

Outcomes assessed at week 1, 2 and 3.
1) 'Cure rate' of participants: defined as able to achieve 90% of normal passive glenohumeral range of motion for abduction and external rotation
2) Pain; assessed on a visual analogue scale; the authors do not report details of the scale.
3) Adverse events: number of cases of epigastric pain and number with injection site pain.

Notes

Cumulative proportion of 'cured' participants in each group after 1,2 and 3 weeks is reported in a figure. Only baseline pain VAS scores and p‐values resulting from comparison of the (unreported) VAS scores between the two groups for week 1 and week 2 were reported. Number cured was extracted from the figure by the review authors and we have contacted the authors for a description of the pain VAS score and the mean and standard deviation in pain scores at each follow‐up. The authors report that the cure rate was higher in the injection group at one, two and three weeks. The VAS score was significantly different (does not state in which direction) after one week of therapy (p=0.022), but not after two weeks (p=0.239).
Three participants in the injection group reported pain at the injection site and 3 participants in the oral steroid group reported epigastric pain. No external funding acknowledgements listed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear