Brox 1993.

Methods	Design: single‐centre, 3‐arm, randomised trial Setting: public hospital surgery and physiotherapy departments in Norway, patients referred from general practitioners in the hospital catchment area Timing: not reported, trial reported in 1993 Interventions: ASD + exercise vs exercise therapy vs sham laser Sample size: the study was planned to detect a difference of 10 points between groups, which equals a reduction from moderate to mild pain. After a pilot study the SD was estimated at 13 points. With α set at 0 05 and, ß 0.10 36 participants were required for each treatment group to complete the trial. Analysis: ITT analysis
Participants	Number of participants 444 considered for inclusion 195 fulfilled eligibility criteria 125 consented and randomised (45 ASD; 30 placebo laser; 50 exercises) Data for 31 (69%) for ASD, 27 (90%) for placebo and 42 (84%) for exercises at 3 months; and 41 (91%) for ASD, 30 (100%) for placebo and 49 (98%) for exercises at 6 months Inclusion criteria Age 18‐66 years Pain in shoulder > 3 months Resistant to physiotherapy, NSAIDs, steroids Dysfunction or pain on abduction Normal passive glenohumeral ROM Pain during 2 of 3 isometric‐eccentric tests (abduction at 0° and 30° and external rotation) Positive results in tests for impingement; positive response to subacromial injection of local anaesthetic into the subacromial space Exclusion criteria Arthritis of AC joint Cervical syndrome Rupture of the rotator cuff Glenohumeral instability Bilateral muscular pain with tenderness Severely decreased ability to relax shoulder, neck, and temporomandibular joints on examination Reluctant to accept ≥ 1 study treatments Baseline characteristics Surgery (ASD) group Mean age: 48 years Number (%) female: 16 (36%) Duration of symptoms: < 6 months 8 (18%); 6‐12 months 8 (18%); 1‐3 years 9 (20%); > 3 years 20 (44%) Number (%) participants with bilateral pain: 11 (24%) Number (%) participants with dominant affected: 28 (62%) Number (%) participants on sick leave: 27 (60%) Number (%) participants on analgesics: 30 (67%) Mean Neer score: 63.6 (pain 13.8; function 22.3; ROM 17.5) Mean Hopkins symptoms checklist score: 1.6 Exercise therapy group Mean age: 47 years Number (%) female: 28 (56%) Duration of symptoms: < 6 months 6 (12%); 6‐12 months 6 (12%); 1‐3 years 13 (26%); > 3 years 25 (50%) Number (%) participants with bilateral pain: 12 (24%) Number (%) participants with dominant affected: 31 (62%) Number (%) participants on sick leave: 27 (54%) Number (%) participants with on analgesics: 39 (77%) Mean Neer score: 66.2 (pain 14.7; function 23.0; ROM 18.5) Mean Hopkins symptoms checklist score: 1.6 Placebo laser group Mean age: 48 Number (%) female: 15 (50%) Duration of symptoms: < 6 months 5 (17%); 6‐12 months 5 (17%); 1‐3 years 5 (17%); > 3 years 14 (48%) Number (%) participants with bilateral pain: 7 (23%) Number (%) participants with dominant side affected: 16 (53%) Number (%) participants with on sick leave: 18 (60%) Number (%) participants with on analgesics: 23 (75%) Mean Neer score: 64.7 (pain 14.8; function 22.1; ROM 17.8) Mean Hopkins symptoms checklist score: 1.6
Interventions	2 experienced surgeons performed the operations and several physiotherapists supervised the postoperative exercises For the exercise group, 1 experienced physiotherapist supervised the exercises. ASD ASD by removing subacromial bursa and anterior and lateral part of acromion as well as cutting AC ligament. Postoperative rehabilitation was started at first postoperative day. Physiotherapy started 1 week after the procedure and was supervised by a physiotherapist where the participant lived. The postoperative regimen did not follow exactly the same protocol as in the exercise group. Exercise therapy The purpose of the exercises were to "normalise the dysfunctional neuromuscular patterns" and "increase the nutrition of the collagen in the rotator cuff". The participants performed exercises 1 h/day; twice weekly with a physiotherapist and other days at home. Resistance was increased gradually. Exercise regimen continued over 3‐6 months Placebo‐laser 12 sessions of detuned soft laser treatment twice a week for 6 weeks
Outcomes	The outcomes were assessed at baseline, 3, 6 months and 2.5 years Primary outcome measure Change in Neer score from baseline to 6 months, (0‐100, higher score indicates better function. Domains: VAS for pain 35 points; clinical testing of function 30 points; active ROM 25 points; anatomical/radiological examination 10 points) Secondary outcomes: Pain with activity (1‐9, higher score indicates worse pain) Pain at rest (1‐9, higher score indicates worse pain) Pain at night (1‐9, higher score indicates worse pain) Neer score (0‐100 higher score indicates better function; due to normal X‐rays at baseline and no X‐rays in follow‐up, the score could range between 10 and 100 in the participants) Change in the main symptom (Likert scale −9 worst to +9 best) reported at 2.5 years only Treatment success defined as those who had > 80 Neer score. Reported at 6 months and 2.5 years Emotional distress on the Hopkins symptom checklist reported at baseline only (0‐4, higher score indicating higher anxiety and depression) Length of sick leave Cost of surgery and cost of exercise Isometric abduction endurance at 2.5 years only Disability to carry 5 kg at the side (1‐7, higher score indicating higher disability) at 2.5 years only Disability to take down something from a wall cupboard (1‐7, higher score indicating higher disability) at 2.5 years only Shoulder‐related absence from work (reported at 6 months and 2.5 years in 1999 paper for those participants not lost to follow‐up by 2.5 years) Outcomes used in this review Mean pain; pain on activity (NRS) Mean function; Neer score Participation (number at work)
Source of funding	Norwegian Research Council
Notes	Trial registration: not available Data analysis: we included only the comparison ASD versus exercise in the surgery versus exercises analysis. Placebo laser was not relevant to our review question. Trial authors reported median values in the original publications, but provided full data regarding pain and Neer score upon request. Pain was measured on a 1‐9 scale and we transformed pain values and SD to a 0‐10 scale before analyses using the formula from Thorlund 2011. 2.5 year results were used in sensitivity analysis 1‐3 years' time point (Analysis 5.4). Participation to work per protocol data used Withdrawals: 4/45 in arthroscopic surgery group did not attend follow‐up, reasons unclear Cross‐overs: 1/50 participant in exercise group had surgery. 3/45 participants in the surgery group had only exercises AEs: none reported SAEs: none reported Trial authors performed an interim analysis of 68 participants who completed 6 months' follow‐up and found that surgery or exercises were superior to placebo laser, and thus stopped allocating participants to placebo laser (hence the smaller number of participants). The trial authors did not appear to statistically adjust for the interim analysis in the final analysis.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Sequence generation not described. Random permuted blocks to ensure allocation concealment. Probably done
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants in the surgery and exercise groups were not blinded. Participants in the placebo‐laser arm were told they were receiving a new type of laser treatment so were blinded to being allocated to placebo laser
Blinding of outcome assessment for self‐reported outcomes including pain, function and global assessment (detection bias)	High risk	Participants were aware of whether or not they received surgery or exercise. Participants in the placebo laser arm were blinded to having received placebo laser therapy.
Blinding of outcome assessment for outcome assessor reported outcomes (detection bias)	Low risk	Outcome assessors were blinded to treatment intervention. Quote: "At follow up the patients wore a T‐shirt to hide a possible scar from surgery. They were carefully told not to talk about their treatment."
Incomplete outcome data (attrition bias) All outcomes	Low risk	There were 4/45 participants in the arthroscopic group and 1/50 in the supervised exercise group who were lost to follow‐up
Selective reporting (reporting bias)	Unclear risk	No protocol was available to confirm all measured outcomes were reported. AEs were not reported and it is unclear if these were measured. Length of sick leave was measured but incompletely reported. Change in the main symptom and disability to carry 5 kg object and take down something was only reported at 2.5 years and as proportion 50% improved. Global success was also not reported as an outcome in the first paper but included as an outcome at 6 months and 2.5 years. This measure was based on Neer score and unclear if post hoc definition of cut‐off caused bias.
Other bias	High risk	We judged other bias to be at high risk due to an unplanned interim analysis performed after 68 participants had been followed up for 6 months. At this point randomisation to the placebo‐laser group was ceased, which led to unbalanced numbers across the 3 treatment groups. 9/45 (20%) allocated to surgery did not undergo ASD, and 7/50 (14%) allocated to exercises did not complete the planned exercises and 1 of these had ASD. However the analysis was performed on an ITT basis irrespective of whether or not the allocated treatment was received