Finnish Subacromial Impingement Arthroscopy Controlled Trial (FIMPACT): a protocol for a randomised trial comparing arthroscopic subacromial decompression and diagnostic arthroscopy (placebo control), with an exercise therapy control, in the treatment of shoulder impingement syndrome

Abstract

IntroductionArthroscopic subacromial decompression (ASD) is the most commonly performed surgical intervention for shoulder pain, yet evidence on its efficacy is limited. The rationale for the surgery rests on the tenet that symptom relief is achieved through decompression of the rotator cuff tendon passage. The primary objective of this superiority trial is to compare the efficacy of ASD versus diagnostic arthroscopy (DA) in patients with shoulder impingement syndrome (SIS), where DA differs only by the lack of subacromial decompression. A third group of supervised progressive exercise therapy (ET) will allow for pragmatic assessment of the relative benefits of surgical versus non-operative treatment strategies.Methods and AnalysisFinnish Subacromial Impingement Arthroscopy Controlled Trial is an ongoing multicentre, three-group randomised controlled study. We performed two-fold concealed allocation, first by randomising patients to surgical (ASD or DA) or conservative (ET) treatment in 2:1 ratio and then those allocated to surgery further to ASD or DA in 1:1 ratio. Our two primary outcomes are pain at rest and at arm activity, assessed using visual analogue scale (VAS). We will quantify the treatment effect as the difference between the groups in the change in the VAS scales with the associated 95% CI at 24 months. Our secondary outcomes are functional assessment (Constant score and Simple shoulder test), quality of life (15D and SF-36), patient satisfaction, proportions of responders and non-responders, reoperations/treatment conversions, all at 2 years post-randomisation, as well as adverse effects and complications. We recruited a total of 210 patients from three tertiary referral centres. We will conduct the primary analysis on the intention-to-treat basis.Ethics and DisseminationThe study was approved by the Institutional Review Board of the Pirkanmaa Hospital District and duly registered at ClinicalTrials.gov. The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations.Trial registration numberNCT00428870; Pre-results.

Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: a 5-year follow-up of a randomised, placebo surgery controlled clinical trial

“…There was a statistically significant between group difference in CM score in favour of ASD (7.1, 0.9 to 13.4; p=0.025) (table 2 and online supplementary appendix table S2 Original research in our protocol. 11 We found no significant between group differences in any of the other secondary outcomes (table 2 and online supplementary appendix table S2). Participants in the diagnostic arthroscopy group were no more likely than participants in the ASD group to guess that they had undergone a placebo procedure (22/53 (42%) vs 21/54 (39%), respectively; p=0.85).…”

Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: randomised, placebo surgery controlled clinical trial

“…Details of the trial design and conduct have been published elsewhere. 11 The patients, the people who collected and analysed the data, and those who interpreted the principal findings for the ASD versus diagnostic arthroscopy comparison (see below, “Blinded data interpretation”) were unaware of the study group assignments. On entering the study, patients were unequivocally informed that they might undergo diagnostic arthroscopy and that they would be allowed to consider crossing over to ASD if they did not have adequate relief of symptoms, preferably no sooner than six months after randomisation.…”

Effects of Adding Interferential Therapy Electro-Massage to Usual Care after Surgery in Subacromial Pain Syndrome: A Randomized Clinical Trial

“…Overall, the combination of imaging features and clinical tests can help to confirm the presence of SAPS [30]. Acromioplasty was considered a feasible intervention for patients between 20 and 80 years, with anterior shoulder pain lasting more than three months [34], and who received previous conservative treatment (manual therapy, pharmacological treatment, and use of corticosteroid injections) with no satisfactory results [35]. Those participants with a self-reported pain intensity ≥30mm in the visual analogue scale (VAS), and a score <45 points on the personal psychological apprehension scale (PPAS) [36], were invited to participate.…”