Rahme 1998.
| Methods | Design: RCT Setting: orthopedic department in a public hospital in Sweden Timing: 1986‐1988 Interventions: open subacromial decompression versus physiotherapy Sample size: 42 participants, power analysis not reported Analysis: as‐treated analysis | |
| Participants |
Number of participants Participants screened for eligibility: not reported 42 randomised (21 to exercise therapy; 21 to surgery) Data for 39 (18 (86%) for exercise therapy and 21 (100%) for ASD) at 6‐month and 12‐month follow‐up points Inclusion criteria
Exclusion criteria
Baseline characteristics Group data not reported separately Mean age (range): 42 (28‐63) years female n (%): 23 (55%) |
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| Interventions |
ASD Open anterior acromioplasty (Neer technique) with any portion of the acromion which extended beyond the anterior border of the clavicle being osteotomised vertically before removing the area of the anteroinferior surface of the acromion; followed by a physiotherapy regime including exercise and education, starting about 3 months after surgery Exercise therapy The physiotherapy regime was based mainly on the principles of Bohmer: information to the participant on functional anatomy and biomechanics of the shoulder; advice on how to avoid positions for 'wear and tear' of the subacromial structures; unloaded movements of the shoulder; measures to normalise the scapulohumeral rhythm and to increase postural awareness; strengthening of the shoulder muscles and endurance training. Submaximal training of the rotator cuff was started about 3 months after the operation in group 1 and when pain had subsided in group 2. Initially all participants were seen 2‐3 times per week and the intervals between treatments were successively increased as they became more familiar with the object of the exercises. |
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| Outcomes | The outcomes were measured at 8 weeks, 16 weeks, 6 months and 12 months Outcomes
Outcomes used in this review
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| Source of funding | Not reported | |
| Notes |
Trial registration: not registered Data analysis: pain values or variance not reported. We requested absolute values from the trial author, but did not receive additional data. We included data for the participants in the exercise group who received surgery in the exercise group for the purpose of meta‐analysis (only data for participant global success available from the published report). Withdrawals: 3 participants in exercise group dropped out Cross‐overs: participants were allowed cross‐over from exercise to surgery after 6 months. In exercise group, 12 (57%) participants were operated before 1‐year follow‐up. 6 participants in surgery group had full‐thickness tears, which were repaired in conjunction with ASD AEs: none reported, unclear if they were measured SAEs: none reported, unclear if they were measured |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | The participants were randomised to 2 treatment groups using blocked randomisation. Sequence generation not reported |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | The participants and personnel were likely not blinded to treatment allocation (not explicitly reported) |
| Blinding of outcome assessment for self‐reported outcomes including pain, function and global assessment (detection bias) | High risk | The participants were not blinded |
| Blinding of outcome assessment for outcome assessor reported outcomes (detection bias) | Low risk | There were no outcome assessor‐reported outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 3/21 (14%) participants dropped out from the exercise group and reasons were not provided |
| Selective reporting (reporting bias) | High risk | The outcomes specified in the methods were not reported consistently and at all time points. Only 6‐month and 12‐month results for pain were reported |
| Other bias | High risk | 3/21 (14%) participants had full‐thickness tears identified at arthroscopy in the operative group while the number of participants with similar tears in the exercise group is unknown. 12/21 (57%) of participants originally allocated to exercises crossed over to surgery after 6 months. The trial authors analysed them as a separate group (not an ITT analysis). |
AC: acromioclavicular; ADL: activities of daily living; AE: adverse event; ASD: arthroscopic subacromial decompression; GHJ: glenohumeral joint;HADS: Hospital Anxiety and Depression Scale; HRQoL: health‐related quality of life; ITT: intention‐to‐treat; MCID: minimum clinically important difference; MRA: magnetic resonance arthrography; MRI: magnetic resonance imaging; NRS: numeric rating scale; NSAID: non‐steroidal anti‐inflammatory drug; PRIM: Project on Research and Intervention in Monotonous work score: QoL: quality of life; RCT: randomised controlled trial; ROM: range of motion; SAE: serious adverse event; SD: standard deviation; SDQ: Shoulder Disability Questionnaire score; VAS: visual analogue scale