NCT01623011: CSAW

Can Shoulder Arthroscopy Work

Completed NA Last updated 30 May 2024

What this trial tests

NA trial testing Arthroscopic Sub-acromial Decompression Surgery in Shoulder Impingement Syndrome in 313 participants. Completed in 27 July 2016.

Timeline

14 September 2012

Primary endpoint
15 December 2015

27 July 2016

Quick facts

Lead sponsor	University of Oxford
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	313
Start date	14 September 2012
Primary completion	15 December 2015
Estimated completion	27 July 2016
Sites	1 location across United Kingdom

Drugs / interventions tested

• Arthroscopic Sub-acromial Decompression Surgery
• Shoulder Arthroscopy
• Active Monitoring with Specialist Reassessment

Conditions studied

• Shoulder Impingement Syndrome — all drugs for Shoulder Impingement Syndrome →

Sponsor

University of Oxford

Who can join

Adults 35 to 75, any sex, with Shoulder Impingement Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Shoulder problems causing pain and decreased function are very common. Many of these problems are related to the rotator cuff tendons. Shoulder arthroscopy surgery (keyhole surgery) is a common treatment for this pain. This can involve an Arthroscopic Subacromial Decompression (ASAD) an operation used to remove bony spurs which may be the cause of the pain. This procedure is widely used despite limited evidence of any effectiveness. This is a randomised controlled trial that will compare ASAD against an investigational shoulder arthroscopy (without spur removal/decompression) to indicate whether spur removal is really necessary and in turn, assessing the effectiveness of the ASAD procedure. Both surgical interventions are routine and will mirror each other except for the spur removal element. Both treatments will be compared against a control (non operative management with specialist reassessment) group to indicate whether surgery in general is effective for patients with subacromial pain. Patients randomised to either of the surgical options will be blinded to the type of surgery they have. This is a multicentre trial taking place in 10 centres in England and Wales. Two satellite studies will also take place. One will involve a subset of patients undergoing MRI scans to examine the effects of their shoulder pain on their brain transmissions. The other will involve collecting tissue samples from patients undergoing surgery.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial.
   Beard DJ, Rees JL, Cook JA, Rombach I, et al · · 2018 · cited 307× · PMID 29169668 · DOI 10.1016/s0140-6736(17)32457-1
2. Use of placebo controls in the evaluation of surgery: systematic review.
   Wartolowska K, Judge A, Hopewell S, Collins GS, et al · · 2014 · cited 190× · PMID 24850821 · DOI 10.1136/bmj.g3253
3. Subacromial decompression surgery for rotator cuff disease.
   Karjalainen TV, Jain NB, Jain NB, Page CM, et al · · 2019 · cited 57× · PMID 30707445 · DOI 10.1002/14651858.cd005619.pub3
4. Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review.
   Wartolowska K, Collins GS, Hopewell S, Judge A, et al · · 2016 · cited 50× · PMID 27008687 · DOI 10.1136/bmjopen-2015-010194
5. Randomised placebo-controlled trials of surgery: ethical analysis and guidelines.
   Savulescu J, Wartolowska K, Carr A. · · 2016 · cited 37× · PMID 27777269 · DOI 10.1136/medethics-2015-103333
6. The magnitude and temporal changes of response in the placebo arm of surgical randomized controlled trials: a systematic review and meta-analysis.
   Wartolowska KA, Feakins BG, Collins GS, Cook J, et al · · 2016 · cited 33× · PMID 27955685 · DOI 10.1186/s13063-016-1720-7
7. 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.
   Beard D, Rees J, Rombach I, Cooper C, et al · · 2015 · cited 32× · PMID 25956385 · DOI 10.1186/s13063-015-0725-y
8. A meta-analysis of temporal changes of response in the placebo arm of surgical randomized controlled trials: an update.
   Wartolowska KA, Gerry S, Feakins BG, Collins GS, et al · · 2017 · cited 26× · PMID 28701195 · DOI 10.1186/s13063-017-2070-9