Maryam 2012.
| Methods |
Design: Parallel group, three‐arm, single blind randomised controlled trial (Iran) Interventions: Physiotherapy (transcutaneous electrical nerve stimulation, active range of motion exercises, and ice application) or glucocorticoid injection or physiotherapy plus glucocorticoid injection Sample size calculation: 35 participants per group were estimated to be needed based upon detecting 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 |
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| Participants |
Number of participants: 87 (27, 31, and 29 in each respective group) Baseline characteristics: Physiotherapy group: Mean (SD) age = 53.73 (7.49) years; Male:Female = 1:26 Mean (SD) duration of symptoms: 4.48 (3.37) months Glucocorticoid injection group: Mean (SD) age = 53.33 (7.49) years; Male:Female = 4:25 Mean (SD) duration of symptoms: 6.83 (3.75) months Physiotherapy plus glucocorticoid injection group: Mean (SD) age = 53.71 (6.69) years; Male:Female = 4:27 Mean (SD) duration of symptoms: 6.21 (3.95) months Inclusion criteria: 1. 18 years or older 2. Duration of symptoms were <1 year 3. 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 contra lateral shoulder 4. Total score of ≥30 on Shoulder Pain and Disability Index (SPADI) Exclusion criteria: 1. Disorder was secondary to inflammatory, degenerative, metabolic (except for diabetes mellitus), trauma, septic arthritis and cerebrovascular accident 2. Had been treated with injection or physiotherapy in last six months |
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| Interventions |
Physiotherapy (N=27) Components of intervention: ‐ Electrotherapy: TENS ‐ Supervised exercises: Active range of motion exercises ‐ 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: Cortiosteroid injection included as 60 milligrams triamcinolone acetonide and 3 cc lidocaine in shoulder joint with posterior approach and 20 milligrams 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) one week after glucocorticoid injection (as above) |
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| Outcomes | Outcomes assessed at six weeks and six months. No primary outcome was reported by the trialists 1. Shoulder pain and disability index (SPADI) (0‐100 scale where a higher score indicates worse pain and/or disability) 2. Passive range of motion in flexion, abduction, external rotation, and distance of hand behind back using a goniometer |
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| 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) |
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| 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 on how the allocation sequence was generated was reported |
| 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 on how the allocation sequence was concealed was reported |
| 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 was fully reported for all outcomes specified in the trial registry entry |
| Other bias | Low risk | Comment: No other sources of bias identified |