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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

The CSAW Study (Can Shoulder Arthroscopy Work?) – a placebo-controlled surgical intervention trial assessing the clinical and cost effectiveness of arthroscopic subacromial decompression for shoulder pain: study protocol for a randomised controlled trial

Authors: David Beard, Jonathan Rees, Ines Rombach, Cushla Cooper, Jonathan Cook, Naomi Merritt, Alastair Gray, Stephen Gwilym, Andrew Judge, Julian Savulescu, Jane Moser, Jenny Donovan, Marcus Jepson, Caroline Wilson, Irene Tracey, Karolina Wartolowska, Benjamin Dean, Andrew Carr, the CSAW Study Group

Published in: Trials | Issue 1/2015

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Abstract

Background

Arthroscopic subacromial decompression (ASAD) is a commonly performed surgical intervention for shoulder pain. The rationale is that removal of a bony acromial spur relieves symptoms by decompressing rotator cuff tendons passing through the subacromial space. However, the efficacy of this procedure is uncertain. The objective of this trial was to compare the efficacy and cost-effectiveness of ASAD in patients with subacromial pain using appropriate control groups, including placebo intervention.

Methods/Design

The trial is a three-group, parallel design, pragmatic, randomised controlled study. The intervention content for each group (ASAD, active monitoring with specialist reassessment (AMSR) and investigational shoulder arthroscopy only (AO)) enables assessment of (1) the efficacy of the surgery against no surgery; (2) the need for a specific component of the surgery—namely, removal of the bony spur; and (3) quantification of the placebo effect. Concealed allocation was performed using a 1:1:1 randomisation ratio and using age, sex, baseline Oxford Shoulder Score (OSS) and centre as minimisation criteria. The primary outcome measure is the OSS at 6 months post randomisation. A total of 300 patients recruited over 24 months from a minimum of 14 UK shoulder units over 24 months were required to detect a difference of 4.5 points on the OSS (standard deviation, 9) with 90% power and to allow for 15% loss to follow-up. Secondary outcomes include cost-effectiveness, pain, complications and patient satisfaction. A substantial qualitative research component is included. The primary analysis will be conducted on the modified intention-to-treat analysis. Sensitivity analysis will be used to assess the robustness of the results with regard to the underlying assumptions about missing data using multiple imputation.

Discussion

This trial uses an innovative design to account for the known placebo effects of surgery, but it also will delineate the mechanism for any benefit from surgery. The investigational AO group is considered a placebo intervention (not sham surgery), as it includes all components of subacromial decompression except the critical surgical element. Some discussion is also dedicated to the challenges of conducting placebo surgery trials.

Trial registrations

UK Clinical Research Network UKCRN12104. Registered 22 May 2012.
International Standard Randomised Controlled Trial ISRCTN33864128. Registered 22 June 2012.
ClinicalTrials.gov NCT01623011. Registered 15 June 2012.
Appendix
Available only for authorised users
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Metadata
Title
The CSAW Study (Can Shoulder Arthroscopy Work?) – a placebo-controlled surgical intervention trial assessing the clinical and cost effectiveness of arthroscopic subacromial decompression for shoulder pain: study protocol for a randomised controlled trial
Authors
David Beard
Jonathan Rees
Ines Rombach
Cushla Cooper
Jonathan Cook
Naomi Merritt
Alastair Gray
Stephen Gwilym
Andrew Judge
Julian Savulescu
Jane Moser
Jenny Donovan
Marcus Jepson
Caroline Wilson
Irene Tracey
Karolina Wartolowska
Benjamin Dean
Andrew Carr
the CSAW Study Group
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0725-y

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