Farfaras 2016.

Methods	Design: parallel‐group, 3‐arm RCT Setting: Uddevalla, Sweden Timing: November 1998–January 2002 Interventions: open subacromial decompression vs ASD vs physiotherapy Sample size: the study design was planned to include 40 participants in each treatment group. A 10‐point difference in Constant score was considered to be of clinical importance. A SD of 15, significance level at P < 0.05 and a power level of 80% give an estimated sample size of 36 per group Analysis: per protocol analysis
Participants	Number of participants Number of screened unclear 95 eligible 87 randomised (24 open surgery; 29 arthroscopic surgery; 34 physiotherapy) Data available for 15 (63%) for open surgery; 19 (66%) for arthroscopic surgery; for physiotherapy 21 (62%) at mean follow‐up of 31 months 20 (83%) for open surgery, 18 (62%) and 28 (82%) at mean follow‐up of 13.9 years Inclusion criteria Subacromial pain for ≥ 6 months Exclusion criteria Diabetes mellitus Any neurological or spinal disorder Radiographic osteoarthritis in X‐Ray The presence of chronic joint disorders such as rheumatoid arthritis Total rotator cuff rupture (ultrasound) Baseline characteristics Open surgery group: Mean (SD) age: 52 (9.5) years Number (%) female: 8 (53) Duration of symptoms: 6‐12 months: 2; 13‐36 months: 7; > 36 months 6 Mean (SD) Constant score: 48 (16) Mean (SD) SF‐36 scores: physical functioning 57.3 (13.1); role physical 23.3 (35.9); bodily pain 30.9 (11.8); global health 69.6 (27); vitality 49.3 (26.8); social functioning 80.8 (25.8); role emotional 71.1 (27.5); mental health 74.3 (21.4) Arthroscopic surgery group: Mean (SD) age: 49 (8.9) years Number (%) female 12 (63) Duration of symptoms: 6‐12 months: 2; 13‐36 months: 8; > 36 months 9 Mean (SD) Constant score: 56 (11) Mean (SD) SF‐36 score: physical functioning 61.2 (15.6); role physical 24.7 (33.9); bodily pain 31.9 (15.1); global health 60.1 (22.8); vitality 43.3 (23); social functioning 68.2 (22.5); role emotional 37.9 (44.5); mental health 65.2 (24.8) Exercise group Mean (SD) age: 50 (9.3) years Number (%) female 8 (38) Duration of symptoms: 6‐12 months: 0; 13‐36 months: 7; > 36 months: 14 Mean (SD) Constant score: 56 (13) Mean (SD) SF‐36 scores: physical functioning 69.7 (11.1); role physical 18.6 (25.2); bodily pain 33.2 (14.5); global health 67.3 (21.8); vitality 44.1 (17.2); social functioning 76.1 (18.6); role emotional 63.6 (38.9); mental health 73.5 (20.5)
Interventions	Open surgery group The procedure started with an anterior, lateral 5‐cm skin incision. The deltoid muscle was split and detached from the anterior third of the acromion and the AC joint capsule. After exposing the anterior edge of the acromion, the tendinous anterior third of the acromion was elevated dorsally prior to removing bone. This manoeuvre exposed the coracoacromial ligament. An osteotome was used to remove the anterior edge and the lateral portion of the undersurface of the acromion. The removed bone included the attachment of the coracoacromial ligament. The piece of bone was about 6–9 mm wide and 20 mm long. Proximal to the coracoid, the coracoacromial ligament was cut. Palpation of the undersurface of the acromion was performed to detect any fragments of bone or prominences. The undersurface of the AC joint was palpated and inspected. If osteophytes were present, they were excised. No AC joint resections were performed. Finally, the medial flap of the deltoid was sutured to the capsule of the AC joint, and the lateral flap was sutured to the origin of the deltoid before closure of the wound. Arthroscopic surgery group A traction device was applied to the arm, and a tension to the arm corresponding to 40 N was applied. The shoulder was in 10° of flexion and 40° of abduction. The bony landmarks of the shoulder (the acromion, the clavicle, the AC joint, the coracoid and the coracoacromial ligament) were marked with a pen. A portal for the arthroscope was created on the dorsal side of the shoulder. The GHJ was first evaluated for cartilage changes, disorder of the biceps tendon, labrum and the rotator cuff. Using the same arthroscopic portal, the subacromial space was visualised and a bursectomy was performed with a shaver introduced from a lateral portal. A resection of the anterior edge of the acromion of about 5–8 mm was then carried out, followed by a resection of about 5–8 mm of the anterior–inferior third of the undersurface of the acromion all the way to the AC joint. Postoperative rehabilitation was similar to physiotherapy group. Exercise group The purpose of the physiotherapy treatment was to let the participants find their normal kinematics of the shoulder, without experiencing pain. The gravitational forces on the arm were removed by suspending the arm in a sling fixed to the ceiling. The training programme started with rotational movements of the arm. As soon as the participant was able to perform these motions without pain, flexion/extension movements were added, followed by abduction/adduction exercises. The training programme postulates everyday practice of at least 60 min. The load was gradually increased in order to strengthen the rotator cuff and the scapula‐stabilising muscles. In the final stage of the programme, the participants replaced some exercises with corresponding leisure activities. The programme was performed twice a week under the supervision of a physiotherapist and the rest of the days at home for a period of 3‐6 months. In order to secure similar treatment, all the participants were trained at 5 local physiotherapy centres by physiotherapists using the same standardised protocol
Outcomes	Outomes were assessed at mean of 30.7 months and 13.9 years after the start of the therapy Primary outcome Constant score (0‐100, higher score indicates better function) Secondary outcomes SF‐36 (0‐1, higher score indicates lower disability) Watson and Sonnabend score ROM of internal rotation and abduction Elevation strength Ultrasound and radiographic evaluation at 12‐13 years (cuff tendons) Outcomes included in this review Mean function; Constant score Mean HRQoL; SF‐36 Mental health score
Source of funding	One or more of the authors has declared the following potential conflict of interest or source of funding: remuneration for lecturing for Linvatec
Notes	Trial registration: not registered Data analysis: 31‐month data was used in > 12‐month time point. We combined open and arthroscopic surgery groups to 1 surgery group because the method of decompression was irrelevant in this review (Analysis 2.2; Analysis 5.4). Withdrawals: at 31 months 1 participant had died, 1 participant missing data and 1 participant no follow‐up in open surgery; 2 participants missing values and 2 participants no follow‐up in arthroscopic surgery group; 6 participants missing data and 4 participants no follow‐up in exercise group Cross‐overs: trial authors excluded participants who crossed over to surgery from exercise group or did not have surgery in surgery groups. In surgery groups, 11/53 (21%) declined operation and in exercises 3/34 (9%) were operated. AEs: not reported SAEs: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	No random sequence generation was described. Quote: "One hundred and twenty envelopes were placed in four boxes: males <55 years, males ≥55 years, females <55 years and females ≥55 years. Each box contained 30 envelopes, 10 for each treatment group."
Allocation concealment (selection bias)	High risk	Quote: "The patients were asked to choose one envelope from the box corresponding to their age and gender." Comment: It is unclear if the envelopes were in random order or if the envelopes were adequately concealed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding of participants or personnel was attempted
Blinding of outcome assessment for self‐reported outcomes including pain, function and global assessment (detection bias)	High risk	Participants were aware of their treatment allocation
Blinding of outcome assessment for outcome assessor reported outcomes (detection bias)	Low risk	Participants wore T‐shirts to hide the scars from outcome assessors
Incomplete outcome data (attrition bias) All outcomes	High risk	Data from 9/24 in the open surgery group, 10/29 in the arthroscopic and 13/34 in the exercise group were not included in the analysis (as only a per‐protocol analysis was performed)
Selective reporting (reporting bias)	Unclear risk	No protocol available. It is unclear if the trial authors reported all measured outcomes
Other bias	High risk	There was imbalance in the number of participants across the 3 treatment arms that was not explained. Recruitment was stopped early due to recruitment difficulties