Can Shoulder Arthroscopy Work

NCT01623011 | Completed DMC

• 1 other identifier: CSAW
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Impingement Syndrome

Keywords

Shoulder; Sub-acromial; Rotator Cuff; Impingement

Outcome Measures

Primary Outcomes (1)

• Oxford Shoulder Score

  Patient reported outcome measure of shoulder pain and function.

  6 months post randomisation

Secondary Outcomes (9)

• Oxford Shoulder Score

  12 months post randomisation

• Constant Murley Shoulder Score

  6 and 12 months post randomisation

• Pain DeTECT

  6 and 12 months post randomisation

• Quantitative Sensory Testing

  6 and 12 months post randomisation

• Health Economics - EQ5D

  6 and 12 months post randomisation

Study Arms (3)

Arthroscopic Sub-acromial Decompression

EXPERIMENTAL

Arthroscopic sub-acromial decompression surgery.

Procedure: Arthroscopic Sub-acromial Decompression Surgery

Shoulder Arthroscopy

ACTIVE COMPARATOR

Shoulder arthroscopy only.

Procedure: Shoulder Arthroscopy

Active Monitoring with Specialist Reassessment

OTHER

Active monitoring with specialist reassessment - non-operative control.

Other: Active Monitoring with Specialist Reassessment

Interventions

Arthroscopic Sub-acromial Decompression Surgery PROCEDURE

The procedure involves insertion of the arthroscope into the glenohumeral joint where the joint surface is inspected along with the intra-articular portion of the long head of biceps and the joint surface of the rotator cuff tendons. The arthroscope is then inserted into the sub-acromial bursa which lies outside the rotator cuff tendons and beneath the acromion process of the scapula. In the bursa the acromion and superior surface of the rotator cuff are assessed to ensure the coracoacromial ligament and the AC joint remains intact. The projecting under surface of the distal part of the acromion is resected.

Also known as: ASAD

Arthroscopic Sub-acromial Decompression

Shoulder Arthroscopy PROCEDURE

This is the surgical comparison group. The procedure is performed under general anaesthetic. Patients will undergo a routine investigational arthroscopy. The operation will be performed in exactly the same manner as Group ASAD. The exception is they will not undergo the decompression (bone spur removal). Tissues will be visualised and the joint will be washed out. The time spent in theatre will be similar to that for Group ASAD. These measures provide the AO group with the characteristics necessary to provide a reasonable comparison and account for the placebo effects of surgery.

Also known as: Arthroscopy alone

Shoulder Arthroscopy

Active Monitoring with Specialist Reassessment OTHER

Patients will be advised that they will undergo active monitoring in the short term. They will attend a reassessment appointment 3 months after entering the study. Here, they will be asked to complete questionnaires related to their shoulder pain and undergo a clinical assessment for their shoulder. From an ethical standpoint it is emphasised that it is quite within normal practice to have a period of active monitoring.

Also known as: Non-operative group, Control group

Active Monitoring with Specialist Reassessment

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sub-acromial pain of at least 3 month (tendinopathy and partial tear only).
• Diagnosed by a Consultant of tendinopathic pain or partial thickness rotator cuff tear
• Has had an MRI or Ultrasound Scan to rule out alternative pathology
• Eligible for surgery.
• Completed a conservative management programme previously including:
• physiotherapy that includes a remedial exercise regimen and
• at least x1 cortisone injection but not more than 3 injections.

You may not qualify if:

• Full thickness tear of the rotator cuff tendons evident on MRI or Ultrasound imaging
• Undergone previous surgery on affected shoulder
• Have RA or other inflammatory disorder
• Symptomatic cervical spine pathology
• Previous septic arthritis
• History of radiotherapy on same side as affected shoulder
• Patients who have a strong preference for one treatment over another to an extent that they would not participate if allocated to their non- preferred group.

Sponsors & Collaborators

• University of Oxford: lead
• Arthritis Research UK: collaborator
• University of Aberdeen: collaborator

Study Sites (1)

Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences

Oxford, Oxfordshire, OX3 7LD, United Kingdom

Location

Related Publications (5)

• Beard DJ, Rees JL, Cook JA, Rombach I, Cooper C, Merritt N, Shirkey BA, Donovan JL, Gwilym S, Savulescu J, Moser J, Gray A, Jepson M, Tracey I, Judge A, Wartolowska K, Carr AJ; CSAW Study Group. Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial. Lancet. 2018 Jan 27;391(10118):329-338. doi: 10.1016/S0140-6736(17)32457-1. Epub 2017 Nov 20.

  PMID: 29169668 DERIVED

• Savulescu J, Wartolowska K, Carr A. Randomised placebo-controlled trials of surgery: ethical analysis and guidelines. J Med Ethics. 2016 Dec;42(12):776-783. doi: 10.1136/medethics-2015-103333. Epub 2016 Oct 24.

  PMID: 27777269 DERIVED

• Wartolowska K, Collins GS, Hopewell S, Judge A, Dean BJ, Rombach I, Beard DJ, Carr AJ. Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review. BMJ Open. 2016 Mar 15;6(3):e010194. doi: 10.1136/bmjopen-2015-010194.

  PMID: 27008687 DERIVED

• Beard D, Rees J, Rombach I, Cooper C, Cook J, Merritt N, Gray A, Gwilym S, Judge A, Savulescu J, Moser J, Donovan J, Jepson M, Wilson C, Tracey I, Wartolowska K, Dean B, Carr A; CSAW Study Group. 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. Trials. 2015 May 9;16:210. doi: 10.1186/s13063-015-0725-y.

  PMID: 25956385 DERIVED

• Wartolowska K, Beard DJ, Carr AJ. Attitudes and beliefs about placebo surgery among orthopedic shoulder surgeons in the United Kingdom. PLoS One. 2014 Mar 14;9(3):e91699. doi: 10.1371/journal.pone.0091699. eCollection 2014.

  PMID: 24632880 DERIVED

Related Links

• Webpage

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Arthroscopy; Control Groups

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• David J Beard, Professor

  University of Oxford

  STUDY CHAIR

• Andrew J Carr, Professor

  University of Oxford

  STUDY CHAIR

• Jonathan Rees

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Jonathan Cook

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

• Irene Tracey

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Steven Gwilym

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Cushla Cooper

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: June 19, 2012
• Study Start: September 14, 2012
• Primary Completion: December 15, 2015
• Study Completion: July 27, 2016
• Last Updated: May 30, 2024

Record last verified: 2017-11

Locations

GB (1)