1. Subacromial decompression versus diagnostic arthroscopy for shoulder impingement : randomised, placebo surgery controlled clinical trial
- Author
-
Jari Inkinen, Jonas Ranstam, Kari Kanto, Mika Paavola, Juha Kalske, Ilkka Sinisaari, Antti Malmivaara, Vesa Savolainen, Simo Taimela, Teppo L. N. Järvinen, Department of Surgery, I kirurgian klinikka (Töölö), Clinicum, FICEBO, University of Helsinki, Doctoral Programme in Clinical Research, and HUS Musculoskeletal and Plastic Surgery
- Subjects
Male ,Minimal Clinically Important Difference ,law.invention ,Arthroscopy ,0302 clinical medicine ,Postoperative Complications ,Randomized controlled trial ,law ,030212 general & internal medicine ,030222 orthopedics ,medicine.diagnostic_test ,DEGENERATIVE MENISCAL TEAR ,Minimal clinically important difference ,Sham surgery ,General Medicine ,Middle Aged ,Decompression, Surgical ,3. Good health ,Exercise Therapy ,Intention to Treat Analysis ,Treatment Outcome ,Shoulder Impingement Syndrome ,ROTATOR CUFF REPAIR ,Female ,Adult ,medicine.medical_specialty ,VERTEBROPLASTY ,Visual analogue scale ,Movement ,KNEE OSTEOARTHRITIS ,SHAM SURGERY ,Placebo ,PARTIAL MENISCECTOMY ,03 medical and health sciences ,Double-Blind Method ,FRACTURES ,Shoulder Pain ,medicine ,MANAGEMENT ,Humans ,Aged ,Intention-to-treat analysis ,business.industry ,ACROMIOPLASTY ,3126 Surgery, anesthesiology, intensive care, radiology ,Surgery ,business ,FOLLOW-UP - Abstract
Objective To assess the efficacy of arthroscopic subacromial decompression (ASD) by comparing it with diagnostic arthroscopy, a placebo surgical intervention, and with a non-operative alternative, exercise therapy, in a more pragmatic setting. Design Multicentre, three group, randomised, double blind, sham controlled trial. Setting Orthopaedic departments at three public hospitals in Finland. Participants 210 patients with symptoms consistent with shoulder impingement syndrome, enrolled from 1 February 2005 with two year follow-up completed by 25 June 2015. Interventions ASD, diagnostic arthroscopy (placebo control), and exercise therapy. Main outcome measures Shoulder pain at rest and on arm activity (visual analogue scale (VAS) from 0 to 100, with 0 denoting no pain), at 24 months. The threshold for minimal clinically important difference was set at 15. Results In the primary intention to treat analysis (ASD versus diagnostic arthroscopy), no clinically relevant between group differences were seen in the two primary outcomes at 24 months (mean change for ASD 36.0 at rest and 55.4 on activity; for diagnostic arthroscopy 31.4 at rest and 47.5 on activity). The observed mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were −4.6 (95% confidence interval −11.3 to 2.1) points (P=0.18) at rest and −9.0 (−18.1 to 0.2) points (P=0.054) on arm activity. No between group differences were seen between the ASD and diagnostic arthroscopy groups in the secondary outcomes or adverse events. In the secondary comparison (ASD versus exercise therapy), statistically significant differences were found in favour of ASD in the two primary outcomes at 24 months in both VAS at rest (−7.5, −14.0 to −1.0, points; P=0.023) and VAS on arm activity (−12.0, −20.9 to −3.2, points; P=0.008), but the mean differences between groups did not exceed the pre-specified minimal clinically important difference. Of note, this ASD versus exercise therapy comparison is not only confounded by lack of blinding but also likely to be biased in favour of ASD owing to the selective removal of patients with likely poor outcome from the ASD group, without comparable exclusions from the exercise therapy group. Conclusions In this controlled trial involving patients with a shoulder impingement syndrome, arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy at 24 months. Trial registration Clinicaltrials.gov NCT00428870.
- Published
- 2018