Ketola 2009.

Methods	Design: 2‐centre, parallel, 2‐arm, RCT Setting: 2 public hospitals in Finland Timing: June 2001‐July 2004 Interventions: ASD + exercise versus exercise therapy alone Sample size: power calculations were performed using self‐reported pain (0‐10 scale VAS) at 24 months as the outcome measure. Using 1.5 (SD 2.5) as a clinically important between‐group difference, the sample size was estimated to be 45 participants per group, if 5% type I (α) and 20% type II (β) errors were allowed. As the SD of the outcome measure was only a rough estimate, 70 participants were included in both groups Analysis: ITT analysis
Participants	Number of participants Number screened not reported 140 eligible 140 randomised (70 to decompression + exercise and 70 to exercise alone) Data available for 99 (43/70 (61%) for surgery and 56/70 (80%) for exercises) at 6 months; 113 (51/70 (73%) for surgery and 62/70 (89%) for exercises) at 12 months; 134 (68/70 (97%) for surgery and 66/70 (94%) for exercise group) at 2 years; 109 (52/70 (74%) for surgery and 57/70 (81%) for exercise group) at 5 years; and 90 (44 (63%) for surgery and 46 (66%) for exercise group) at 10 years Inclusion criteria Participants aged 18‐60 years and willing to comply with the randomised treatment protocol and follow‐up visits Positive Neer's test (after 5 mL 1% lidocaine had been injected into the subacromial space) Pain in the shoulder that was resistant to rest, anti‐inflammatory drugs, subacromial glucocorticosteroid injections and physiotherapy Symptoms that had persisted for ≥ 3 months Exclusion criteria Glenohumeral or AC osteoarthritis Signs of glenohumeral instability Previous surgery to the affected shoulder Full‐thickness tear of the rotator cuff Cervical radicular syndrome Adhesive capsulitis or neuropathy of the shoulder region Baseline data Surgery group (ASD) Mean (range) age: 46.4 (23.3‐60.0) years Number (%) of female: 47 (67%) Mean (range) BMI: 27.4 (19.5 – 46.3) Dominant hand affected n (%): 45 (64%) Duration of symptoms, years (range): 2.6 (0.25–20) Mean (range) pain VAS: 6.5 (1‐10) Mean (range) night pain: 6.2 (0–10) Mean (range) disability: 6.2 (1–10) Mean (range) working ability (range): 5.7 (0–9) Mean (range) SDQ score (range): 78.0 Exercise group Age, mean (range): 47.8 (26.8‐59.2) years Number (%) female: 41 (59%) Mean (range) BMI: 27 (15.2‐41.2) Dominant hand affected: 46 (66%) Duration of symptoms, years (range): 2.5 (0.25–17) Mean (range) pain VAS: 6.5 (1.0–10) Mean (range) night pain: 6.4 (0–10) Mean (range) disability (range): 6.5 (2–10) Mean (range) working ability (range): 5.9 (0–9) Mean (range) SDQ score: 82.5
Interventions	1 surgeon performed all operations Surgery (ASD) Acromioplasty + ASD and debridement +/‐ coracoacromial ligament release (participants with thick or tight ligament). Supervised exercise treatment, overnight in hospital, ibuprofen, collar+cuff, mobilisation permitted and free active movement. After 7‐10 days participants commenced on similar programme as exercise group with 6 physiotherapy visits Exercise therapy group Supervised exercise treatment (physiotherapist), individual home programme, sessions 4 times/week, 9 different exercises with 30‐40 repetitions 3 times. 7 control visits by physiotherapist. As self‐assessed ability and strength increased, repetitions diminished. NSAIDs were permitted. Subacromial corticosteroid injections were permitted in both groups if pain interfered with the exercise programme
Outcomes	Outcomes were assessed at baseline, 3, 6, 12, 24 months, 5 years and > 10 years. Primary outcome Pain measured on a 0‐10 VAS (0‐10, higher score indicates worse pain), time point not specified Secondary Disability (0‐10 VAS, higher score indicates more disability) Pain at night (0‐10 VAS, higher score indicates worse pain) Working ability (0‐10 VAS, higher score indicates worse pain) SDQ score (0‐100, higher score indicates more disability) Participants retired and participants retired due to shoulder condition (at 5 and 10 years) Mean number of days absence from work during last 3 months; reported at 10 years in categories 0; 1‐7; 8‐14; > 14 Number of painful days during the previous 3 months (reported at 24 months, 5 years, and 10 years) Proportion of pain‐free participants (defined as VAS < 3), at 24 months, 5 years, and 10 years Overall state of health compared with before treatment (at 10 years only) Mean 15D score (0‐1; higher score indicates better QoL); likely this was added after the study was ongoing and only assessed at 5 and 10 years. Resource use: unit costs (EUR) and mean costs (EUR) of direct healthcare and non‐healthcare costs (travel, massage, manipulation) at 2004 prices MRI (cuff tendons and muscle volume) at 5 years Outcomes used in this review Mean pain; VAS for pain (0‐10) Mean function; SDQ score HRQoL; 15D score (only at 5‐year follow‐up) Participation (work); participants not retired (total ‐ number of retired)
Source of funding	Not stated
Notes	Trial registration: not available Data analysis: original reports do not include 3‐12 months' results but the trial authors provided pain and SDQ score upon request. We inverted SDQ before entering the data (so that higher indicated better). 15D data at 5 years also received from the trial authors. Imbalance in available data between groups at 6 months, probably due to delay in surgery (data not reported for participants not operated before follow‐up point) Withdrawals: in surgery group, 2/70 (3%); In exercise group, 3/70 (4%) Cross‐overs: in surgery group, 13 (19%) cancelled operation: 6 because lack of symptoms; 2 due to work; 1 fear of operation, 2 other reasons, 1 withdrew, 1 underwent manipulation only. 9 (13% also received labral repair during the operation). 14 (20%) participants in the exercise group received surgery. Over the 2‐year follow‐up a mean of 0.3 (range 0‐3) and 1.0 (range 0‐10) glucocorticoid injections were given to the surgical and exercise groups AEs: no major surgical complications reported, AEs in exercise group not specifically reported SAEs: no major surgical complications
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation (using 14 as the block size)
Allocation concealment (selection bias)	Low risk	Computer‐generated numbers sealed in opaque envelopes prepared by an independent statistician not otherwise involved in the study
Blinding of participants and personnel (performance bias) All outcomes	High risk	Neither participants nor study personnel were blinded
Blinding of outcome assessment for self‐reported outcomes including pain, function and global assessment (detection bias)	High risk	Participants were not blinded
Blinding of outcome assessment for outcome assessor reported outcomes (detection bias)	Low risk	A single independent physiotherapist was blinded to treatment allocation as participants wore T‐shirts to cover scars and were asked not to reveal any information regarding their allocation
Incomplete outcome data (attrition bias) All outcomes	High risk	There were missing data at 3, 6 and 12 months and the proportions differed between groups at 3 and 6 months (3 months: 27/70 (39%) in surgery group and 13/70 (19%) in the exercise group; 6 months: 26/70 (37%) in surgery group and 14/70 (20%) in exercise group; 12 months: 19/70 (27%) in surgery group and 18/70 (26%) in exercise group; 24 months: 2/70 (3% ) in the surgery group and 4/70 (6%) in the exercise group. No reasons for missing data were reported
Selective reporting (reporting bias)	Unclear risk	No protocol available. Trial authors reported only 24‐month, 5‐year and 10‐year results in the paper but we received pain in VAS and SDQ‐score at 3, 6 and 12 months from the trial authors. Trial authors stated that there were no major surgical complications but AEs in the exercise arm were not reported. Passive movement and strength were measured but not reported.
Other bias	Unclear risk	9 (13%) participants in the surgery group also received labral repair during the operation, which was an unplanned co‐intervention and may have biased the estimate of the effect of surgery (in either direction). Both treatment groups received glucocorticoid injections over the 2‐year follow‐up (mean 0.3 (range 0‐3) and 1.0 (range 0‐10) glucocorticoid injections in the surgical and exercise groups). This may also have biased the estimate of the effect of surgery. The exercise group 14/70 (20%) had decompression by 24 months. In the surgery group, 13 (18%) did not receive planned surgery. However the analysis was performed on an ITT basis irrespective of whether or not the allocated treatment was received.