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Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial

Authors :
Beard, DJ
Rees, JL
Cook, JA
Rombach, I
Cooper, C
Merritt, N
Shirkey, BA
Donovan, JL
Gwilym, S
Savulescu, J
Moser, J
Gray, A
Jepson, M
Tracey, I
Judge, A
Wartolowska, K
Carr, AJ
Beard, DJ
Rees, JL
Cook, JA
Rombach, I
Cooper, C
Merritt, N
Shirkey, BA
Donovan, JL
Gwilym, S
Savulescu, J
Moser, J
Gray, A
Jepson, M
Tracey, I
Judge, A
Wartolowska, K
Carr, AJ
Publication Year :
2018

Abstract

BACKGROUND: Arthroscopic sub-acromial decompression (decompressing the sub-acromial space by removing bone spurs and soft tissue arthroscopically) is a common surgery for subacromial shoulder pain, but its effectiveness is uncertain. We did a study to assess its effectiveness and to investigate the mechanism for surgical decompression. METHODS: We did a multicentre, randomised, pragmatic, parallel group, placebo-controlled, three-group trial at 32 hospitals in the UK with 51 surgeons. Participants were patients who had subacromial pain for at least 3 months with intact rotator cuff tendons, were eligible for arthroscopic surgery, and had previously completed a non-operative management programme that included exercise therapy and at least one steroid injection. Exclusion criteria included a full-thickness torn rotator cuff. We randomly assigned participants (1:1:1) to arthroscopic subacromial decompression, investigational arthroscopy only, or no treatment (attendance of one reassessment appointment with a specialist shoulder clinician 3 months after study entry, but no intervention). Arthroscopy only was a placebo as the essential surgical element (bone and soft tissue removal) was omitted. We did the randomisation with a computer-generated minimisation system. In the surgical intervention groups, patients were not told which type of surgery they were receiving (to ensure masking). Patients were followed up at 6 months and 1 year after randomisation; surgeons coordinated their waiting lists to schedule surgeries as close as possible to randomisation. The primary outcome was the Oxford Shoulder Score (0 [worst] to 48 [best]) at 6 months, analysed by intention to treat. The sample size calculation was based upon a target difference of 4·5 points (SD 9·0). This trial has been registered at ClinicalTrials.gov, number NCT01623011. FINDINGS: Between Sept 14, 2012, and June 16, 2015, we randomly assigned 313 patients to treatment groups (106 to decompression surgery, 103 t

Details

Database :
OAIster
Publication Type :
Electronic Resource
Accession number :
edsoai.on1315733536
Document Type :
Electronic Resource