Beard 2018.

Methods	Design: multicentre (30 sites), parallel‐group, three‐arm (1:1:1) assessor‐ and participant‐blinded, randomised placebo‐controlled trial Setting: NHS hospitals in UK Timing: September 2012‐July 2016 Interventions: ASD, placebo surgery (arthroscopy only), and no treatment Sample size: 85 participants per group required to have 90% power to detect a difference in the Oxford Shoulder Score of 4.5 (SD 9.0), with a 2‐sided 5% level of significance (α) Analysis: ITT analysis and per‐protocol analysis
Participants	Number of participants 2975 patients screened for eligibility 740 eligible (232 followed in observational cohort due to strong preference, 195 did not partake but reasons not available) 313 randomised (106 to ASD; 103 to arthroscopy only; 104 to no treatment) 24 (23%), 43 (42%), and 12 (12%) of the ASD, arthroscopy only, and no‐treatment groups, respectively, did not receive their assigned treatment by 6 months 19 (18%), 35 (3%), and 26 (25%) of the ASD, arthroscopy only, and no‐treatment groups, respectively, did not receive their assigned treatment by 1 year Data for 274 (90 (85%) for ASD; 94 (91%) for arthroscopy only; and 90 (87%) for no treatment) available at the 6‐month follow‐up Data for 265 (88 (83%) for ASD; 93 (90%) for arthroscopy only; and 84 (81%) for no treatment) available at the final 12‐month follow‐up Inclusion criteria: Subacromial pain of ≥ 3 months’ duration (tendinopathy and partial tear only) Consultant’s clinical diagnosis of tendinopathic pain or partial thickness rotator cuff tear (using local pathways of diagnosis, which may include X‐ray, magnetic resonance imaging (MRI) scan or ultrasound) Eligible for arthroscopic surgery Completion of a conservative management programme previously, including both: physiotherapy that includes a remedial exercise regimen and ≥ 1 glucocorticoid injection Exclusion criteria: Full‐thickness tear of the rotator cuff tendons or calcific tendonitis evident on routine imaging Other shoulder pathology (non‐impingement‐related) identified on MRI scan or ultrasound Undergone any of the following surgeries on the affected shoulder: ASD; cuff repair; joint replacement; surgery involving the glenohumeral joint (GHJ) in the past 3 years Rheumatoid arthritis or any other inflammatory disorder of the joints Symptomatic cervical spine pathology Previous septic arthritis in the shoulder only History of radiotherapy on same side as affected shoulder Patients who are unlikely to be able to perform the required clinical assessment tasks; have significant cognitive impairment or language issues; are unable to provide consent for themselves > 75 years of age Previous septic arthritis in the shoulder only History of radiotherapy on same side as affected shoulder Baseline characteristics ASD group: Mean (SD) age: 52.9 (10.3) 54 female 52 male Previously received injections: 2 (range: 1‐3) Mean (SD) Oxford Shoulder Score: 25.2 (8.5) Mean (SD) Constant‐Murley Shoulder Score: 39.4 (13.9) Mean (SD) PainDETECT score: 11.7 (6.6) Mean (SD) EQ‐VAS: 65.8 (19.4) Mean (SD) EQ‐5D Index: 0.52 (0.30) Mean (SD) HADS Depression score: 5.0 (3.8) Mean (SD) HADS Anxiety Score: 6.3 (4.3) Placebo surgery group: Mean (SD) age: 53.7 (10.5) 52 female 51 male Previously received injections: 2 (range: 1‐3) Mean (SD) Oxford Shoulder Score: 26.7 (8.8) Mean (SD) Constant‐Murley Shoulder Score: 43.1 (15.5) Mean (SD) PainDETECT score: 11.0 (5.9) Mean (SD) EQ‐VAS: 69.7 (19.2) Mean (SD) EQ‐5D Index: 0.55 (0.29) Mean (SD) HADS Depression score: 5.0 (3.7) Mean 8SD) HADS Anxiety Score: 6.3 (4.2) No treatment group: Mean (SD) Age: 53.2 (10.2) 52 female 52 male Previously received injections: 2 (range: 1‐3) Mean (SD) Oxford Shoulder Score: 25.5 (8.3) Mean (SD) Constant‐Murley Shoulder Score: 38.3 (14.2) Mean (SD)PainDETECT score: 11.9 (6.6) Mean (SD)EQ‐VAS: 64.4 (23.2) Mean (SD)EQ‐5D‐3L Index: 0.50 (0.33) Mean (SD)HADS Depression score: 5.7 (4.2) Mean (SD) HADS Anxiety Score: 6.9 (4.5)
Interventions	38 surgeons performed the operations in 30 sites. ASD The procedure was performed with the participant under general anaesthesia. Skin incisions were made for the introduction of the arthroscope and required instruments. The procedure involved insertion of the arthroscope into the GHJ, where the joint surface was inspected along with the intraarticular portion of the long head of biceps and the joint surface of the rotator cuff tendons. Once this was performed, the arthroscope was removed and inserted into the subacromial bursa, which lies outside the rotator cuff tendons and beneath the acromion process of the scapula. In the bursa, the acromion and superior surface of the rotator cuff were assessed to ensure that the coracoacromial ligament and the AC joint were intact. The ASD included removal of bursa and soft tissue within the subacromial space as well as resection of projecting undersurface of the distal part of the acromion. Postoperative physiotherapy involved advice and between 1 and 4 routine treatment sessions. Placebo (arthroscopy only) The procedure was performed with the participant under general anaesthesia. Participants underwent a routine investigational arthroscopy of the joint and rotator cuff tendon. The operation was performed in exactly the same manner as that in the ASD group. Investigational arthroscopy has all the same essential operative components (and risks) of ASD, but it does not involve surgical removal of any spurs or bursal tissue or release of the coracohumeral ligament. The procedure involved the GHJ and the subacromial bursa being inspected and irrigated. Structures assessed for integrity and damage included the rotator cuff, which was assessed for evidence of full‐thickness tears; and the synovium and lining of the shoulder for evidence of capsulitis and arthritis. Postoperative physiotherapy involved advice and between one and four routine treatment sessions. No treatment (active monitoring) Participants were advised that they would undergo active monitoring with a reassessment appointment with a specialist shoulder surgeon 3 months after entering the study. At that appointment, they were asked to complete questionnaires related to their shoulder pain and undergo a clinical assessment of the shoulder, including a record of any further conservative treatment. If, at the end of the 6‐month assessment period, participants remained sufficiently symptomatic to require further intervention (based on clinical judgement), then additional treatment options were discussed. The participants in the no‐treatment group had no prescribed physiotherapy or steroid injections.
Outcomes	Outcomes were reported at baseline, 6 and 12 months. Primary end point was at 12 months Primary outcome Mean Oxford Shoulder Score (0‐48), higher score indicates better function Secondary outcomes Modified Constant‐Murley Shoulder Score (0‐100, higher score indicates better function. Domains: pain 15 points; ADL 20 points, ROM 40 points; strength 25 points) Mean PainDETECT score (0‐38; higher score indicates that neuropathic pain component is more likely) Mean strongest pain on PainDETECT (0‐10; 0 no pain, 10 maximum pain) Mean current pain on PainDETECT (0‐10; 0 no pain, 10 maximum pain) Mean average pain on PainDETECT (0‐10; 0 no pain, 10 maximum pain) Quantitative sensory testing AEs EQ‐5D index (−0.59‐1; higher score indicates better QoL) EQ VAS (0‐100; higher score indicates better QoL) Treatment expectations (measured at 12 months by 6 questions about: relief from symptoms; to do more everyday activities; to sleep more comfortably; to get back to my usual job; to exercise and to recreational activities; to prevent future disability) Global assessment of satisfaction on Oxford satisfaction index; 3 questions: 1) how are the problems now compared to before randomisation (7‐step Likert scale from no problems to much worse); 2) how pleased are you with the results of the treatment (5 step Likert scale from very pleased to very disappointed); and 3) would you choose the same treatment again (yes/no/not sure) HADS (Scale 0‐21 for anxiety and 0‐21 for depression, higher score indicates higher depression or anxiety) Health service use AEs including frozen shoulder, joint and/or soft tissue infection, further shoulder surgery Serious AEs Outcomes included in this review Mean function; Constant score Mean average pain; PainDETECT average pain score (NRS) Mean QoL; EQ‐5D index Global assessment of outcome; proportion of participants who reported no problems at all now or much better in 7‐step Likert scale varying from much worse to no problems at all. Proportion with AEs at 12 months
Source of funding	The study was funded by Arthritis Research UK via a clinical studies grant. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.
Notes	Trial registration: NCT01623011 Data analysis: the primary analysis compared ASD and placebo surgery (arthroscopy only) groups (Analysis 1.1; Analysis 1.2; Analysis 1.3; Analysis 1.4; Analysis 1.7). Had not received allocated treatment by 6 months: 24 (23%), 43 (42%), and 12 (12%) of the decompression, arthroscopy only, and no‐treatment groups, respectively Had not received allocated treatment by 1 year: 19 (18%), 35 (34%), and 26 (25%) of the decompression, arthroscopy only, and no‐treatment groups, respectively The per‐protocol analysis reported no between‐group differences at 6 months or 1 year for the primary outcome of mean Oxford Shoulder Score. Cross overs: 9/103 participants in the placebo surgery group had decompression surgery by 6 months and 10/103 by 12 months. Two participants in the placebo surgery group underwent further surgery (decompression in one and superior labrum debridement in the other). AEs: Two frozen shoulders reported in each of the three groups SAEs: none reported Risk of bias: we separately note the risk of bias for the 2 surgery groups and the monitoring group in the 'Risk of bias' table and authors' judgements are for the comparison of the 2 surgical groups (decompression and placebo). Prof Beard confirmed that postoperative personnel including nurses on the ward were unaware of treatment allocation and postoperative care was identical in the surgery groups.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The randomisation was generated using an automated computer‐generated minimisation system, minimising for age (< 40, 40–55, or ≥ 56 years), sex, baseline Oxford Shoulder Score (< 19, 19–26, 27–33, or ≥ 34 years), and recruiting site
Allocation concealment (selection bias)	Low risk	Quote: "Study site staff who were authorised to perform telephone randomisation contacted the Oxford Clinical Trials Research Unit providing the following information: participant details, research site details, name of caller, name of treating consultant, confirmation of eligibility, confirmation of written informed consent and its date, and stratification factors." Quote: "The surgical group to which the patient was allocated was concealed from the surgical team and revealed only on the day of planned surgery."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants randomly assigned to surgery were not told which procedure they had undergone, decompression or arthroscopy only. Personnel other than the surgical team were blinded to treatment intervention. The time spent in the operating theatre and all postoperative care was identical in both groups. Participants randomised to the monitoring group received a letter stating that a specialist reassessment appointment would be scheduled for a date 3 months hence (the timing of that letter was not specified). We judged blinding for the monitoring group was at high risk of bias.
Blinding of outcome assessment for self‐reported outcomes including pain, function and global assessment (detection bias)	Low risk	The participants were blinded to allocation in the two surgery groups (low risk) but not the monitoring‐only group (high risk).
Blinding of outcome assessment for outcome assessor reported outcomes (detection bias)	Low risk	Postintervention assessors were blinded to treatment allocation across all 3 treatment groups.
Incomplete outcome data (attrition bias) All outcomes	Low risk	The number of participants lost to follow‐up was similar across the 2 surgical groups at 6 months: 15/106 for decompression surgery (7 participants did not respond, 6 withdrew, and 2 were lost for other reasons) and 9/103 for placebo surgery (6 participants did not respond, 2 withdrew, and 1 was lost for other reasons). At 12 months, 18/106 in the decompression surgery group (10 did not respond, 6 withdrew and 2 were lost for other reasons) and 10/103 in the placebo surgery group (6 did not respond, 3 withdrew and 1 was lost for other reasons) were lost to follow‐up.
Selective reporting (reporting bias)	Low risk	The trial authors report all prespecified outcomes except quantitative sensory testing. As this is a tool for assessing disturbances in somatosensory processing and would not be included in the outcomes of this review, we judged this trial to be at low risk of selective reporting bias.
Other bias	Low risk	At 6 and 12 months, 9 (9%) participants and 10 (10%) participants in the placebo surgery group respectively, had crossed over to receive ASD. This may have underestimated any potential benefit of decompression. 24 (23%), 43 (42%), and 12 (12%) of the decompression, arthroscopy‐only, and no‐treatment groups, respectively at 6 months, and 19 (18%), 35 (34%), and 26 (25%) of the decompression, arthroscopy‐only, and no‐treatment groups, respectively at 1 year had not received their assigned treatment. However the analysis was performed on an ITT basis irrespective of whether or not the allocated treatment was received.