Maryam 2012.

Methods	Design: parallel‐group, 3‐arm, single‐blind randomised controlled trial (Iran) Interventions: physiotherapy (including TENS, active range of motion exercises and ice application in 10 sessions) or glucocorticoid injection or physiotherapy plus glucocorticoid injection Sample size calculation: 35 participants per group were estimated to be needed based upon detection of a clinically relevant difference at the 5% level of statistical significance with 80% power (outcome used in power calculation not reported) Analysis: per‐protocol analysis Source of funding: not reported
Participants	Number of participants: 87 (27, 31 and 29 in each respective group) Baseline characteristics Group receiving physiotherapy Mean (SD) age = 53.73 (7.49) years; male:female = 1:26 Mean (SD) duration of symptoms: 4.48 (3.37) months Group receiving glucocorticoid injection Mean (SD) age = 53.33 (7.49) years; male:female = 4:25 Mean (SD) duration of symptoms: 6.83 (3.75) months Group receiving physiotherapy plus glucocorticoid injection Mean (SD) age = 53.71 (6.69) years; male:female = 4:27 Mean (SD) duration of symptoms: 6.21 (3.95) months Inclusion criteria 18 years of age or older Duration of symptoms < 1 year Frozen shoulder defined as the presence of shoulder pain with limitation of both active and passive range of motion in glenohumeral joint ≤ 25% in at least 2 directions: flexion, abduction, external and internal rotation, as compared with normal values or contralateral shoulder Total score ≥ 30 on Shoulder Pain and Disability Index (SPADI) Exclusion criteria Disorder was secondary to inflammatory, degenerative, metabolic (except for diabetes mellitus), traumatic, septic arthritis and cerebrovascular accident Treated with injection or physiotherapy in past 6 months
Interventions	Physiotherapy (N = 27) Components of intervention Supervised exercises: active range of motion exercises Electrotherapy: TENS Other: Ice application Dosage: not reported Frequency of administration: 10 sessions (number of sessions per week not reported) Provider: physiotherapist Glucocorticoid injection (N = 31) Components of intervention: corticosteroid injection included as 60 mg triamcinolone acetonide and 3 cc lidocaine in shoulder joint with posterior approach and 20 mg triamcinolone acetonide and 1.5 cc lidocaine in subacromial bursa Dosage: See above Frequency of administration: once Provider: rheumatologist Physiotherapy plus glucocorticoid injection (N = 29) Physiotherapy (as above) 1 week after glucocorticoid injection (as above)
Outcomes	Outcomes assessed at 6 weeks and 6 months. No primary outcome was reported by trialists Shoulder Pain and Disability Index (SPADI) (0‐100 scale, where a higher score indicates worse pain and/or disability) Passive range of motion in flexion, abduction, external rotation and distance of hand behind back using a goniometer
Notes	Unpublished data regarding study design (required for risk of bias assessment) provided by trialist on request Trial registered in the Iranian Registry of Clinical Trials (http://www.irct.ir/searchresult.php?id=1828&number=1)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "After taking written informed consent, the patients were randomized to 1 of the following 3 groups" Comment: No information was reported on how the allocation sequence was generated
Allocation concealment (selection bias)	Unclear risk	Quote: "After taking written informed consent, the patients were randomized to 1 of the following 3 groups" Comment: No information was reported on how the allocation sequence was concealed
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	Quote: "Evaluations of SPADI score were done by an observer blind to treatment allocation" Comment: Unblinded participants, who may have had different expectations about the benefits of the intervention they received, self‐reported some components of the SPADI
Blinding of outcome assessment (detection bias) Objective outcomes	High risk	Comment: Trialists confirmed via personal communication that the assessor of range of motion was not blind to treatment
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Quote: "Eight patients in physiotherapy group, 7 in combination therapy group and 3 in injection group did not continue, so statistical analysis was done on 69 remaining patients" Quote: "About 36 patients have been reevaluated in 24 weeks (Table‐III). However we cannot consider this stage of study because of a high number of missed patients, but we can see a more subjective improvement during 6 months in physiotherapy group" Comment: Trialists did not report the reasons for participants not continuing (and did not provide this information when requested), so it is unclear whether the reasons were balanced between groups and related to the treatment received
Selective reporting (reporting bias)	Low risk	Comment: Outcome data were fully reported for all outcomes specified in the trial registry entry
Other bias	Low risk	Comment: No other sources of bias were identified