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

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Paavola , M , Malmivaara , A , Taimela , S , Kanto , K & Järvinen , T L N 2017 , ' 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 ' , BMJ Open , vol. 7 , no. 5 , e014087 . https://doi.org/10.1136/bmjopen-2016-014087

Title: 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
Author: Paavola, Mika; Malmivaara, Antti; Taimela, Simo; Kanto, Kari; Järvinen, Teppo L. N.
Contributor: University of Helsinki, Department of Surgery
University of Helsinki, Department of Surgery
University of Helsinki, FICEBO
Date: 2017
Language: eng
Number of pages: 14
Belongs to series: BMJ Open
ISSN: 2044-6055
URI: http://hdl.handle.net/10138/299325
Abstract: Introduction: Arthroscopic 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 Analysis: Finnish 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 Dissemination: The 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. © 2017 Article author(s).
Subject: 15D instrument
adult
arm movement
arthroscope
arthroscopic subacromial decompression
arthroscopic surgery
Article
clinical protocol
comparative effectiveness
Constant Murley (score)
controlled study
female
Finland
functional assessment
human
intermethod comparison
kinesiotherapy
male
multicenter study
musculoskeletal disease assessment
outcome assessment
patient compliance
patient satisfaction
postoperative care
postoperative complication
quality of life
quality of life assessment
randomized controlled trial
reoperation
rest
return to work
Short Form 36
shoulder arthroscopy
shoulder impingement syndrome
shoulder pain
shoulder surgery
simple shoulder test
visual analog scale
aged
arthroscopy
clinical trial
decompression surgery
methodology
middle aged
pain measurement
procedures
statistical model
treatment outcome, Adult
Aged
Arthroscopy
Decompression, Surgical
Exercise Therapy
Female
Humans
Logistic Models
Male
Middle Aged
Pain Measurement
Patient Satisfaction
Quality of Life
Research Design
Shoulder Impingement Syndrome
Shoulder Pain
Treatment Outcome
3126 Surgery, anesthesiology, intensive care, radiology
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