Article Text
Abstract
Objectives To determine the effect of arthroscopic capsular shift surgery on pain and functional impairment for people with atraumatic shoulder (glenohumeral) joint instability.
Methods We conducted a randomised, placebo-controlled clinical trial in a specialist secondary care facility. Patients aged 18 years and over who reported insecurity (apprehension) in their shoulder joint and had evidence of capsulolabral damage on arthroscopic examination were included. Patients were excluded if their shoulder apprehension symptoms were precipitated by a high velocity shoulder injury, they had bony or neural damage, a rotator cuff or labral tear, or previous surgery on the symptomatic shoulder. Sixty-eight participants were randomised and received diagnostic arthroscopy, followed by arthroscopic capsular shift or diagnostic arthroscopy alone. All participants received the same postoperative clinical care. The primary outcome was pain and functional impairment measured with the Western Ontario Shoulder Instability Index. The prespecified minimum clinically important effect was a reduction in pain and disability of 10.4 points.
Results Mean reductions in pain and functional impairment for both groups were similar. Compared with diagnostic arthroscopy, arthroscopic capsular shift increased pain and functional impairment by means of 5 points (95% CI −6 to 16 points) at 6 months, 1 point (95% CI −11 to 13 points) at 12 months and 2 points (95% CI −12 to 17 points) at 24 months.
Conclusions Compared with diagnostic arthroscopy alone, arthroscopic capsular shift confers, at best, only minimal clinically important benefit in the medium term.
Trial registration number NCT01751490.
- Shoulder
- Randomized Controlled Trial
- Surgical Procedures, Operative
Data availability statement
All data relevant to the study are included in the article or uploaded as online supplemental information. The study protocol for this clinical trial has previously been published (Jaggi et alBMC Musculoskeletal Disorders 15:439, 2014) and the Statistical Analysis Plan is publicly available on the Open Science Framework (https://osf.io/kps76/?view_only=dbe79e87bbe240c0a7d3166bf74a2bed). Individual deidentified data will be available for sharing upon publication for a period of at least 15 years following request to the corresponding or first author.
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Data availability statement
All data relevant to the study are included in the article or uploaded as online supplemental information. The study protocol for this clinical trial has previously been published (Jaggi et alBMC Musculoskeletal Disorders 15:439, 2014) and the Statistical Analysis Plan is publicly available on the Open Science Framework (https://osf.io/kps76/?view_only=dbe79e87bbe240c0a7d3166bf74a2bed). Individual deidentified data will be available for sharing upon publication for a period of at least 15 years following request to the corresponding or first author.
Footnotes
Contributors Study conceptualisation and design: AJ, RDH, SA and KAG. Data collection and curation: AJ, SA, AM, DB, WR, DH and KAG. Validation of results and statistical analysis: RDH and KAG. Project administration and supervision: AJ and KAG. Interpretation of results, visualisation and writing of manuscript: all authors. Guarantor: KAG
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.