Can Shoulder Arthroscopy Work (CSAW)

This study is currently recruiting participants.
Verified January 2013 by University of Oxford
Sponsor:
Collaborators:
Arthritis Research UK
University of Aberdeen
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01623011
First received: June 15, 2012
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Shoulder Impingement Syndrome
Procedure: Arthroscopic Sub-acromial Decompression Surgery
Procedure: Shoulder Arthroscopy
Other: Active Monitoring with Specialist Reassessment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: What is the Clinical and Cost Effectiveness of Arthroscopic Sub-acromial Decompression Surgery?

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Oxford Shoulder Score [ Time Frame: 6 months post randomisation ] [ Designated as safety issue: No ]
    Patient reported outcome measure of shoulder pain and function.


Secondary Outcome Measures:
  • Oxford Shoulder Score [ Time Frame: 12 months post randomisation ] [ Designated as safety issue: No ]
    Patient reported outcome measure of shoulder pain and function

  • Constant Murley Shoulder Score [ Time Frame: 6 and 12 months post randomisation ] [ Designated as safety issue: No ]
    Clinical assessment of the shoulder

  • Pain DeTECT [ Time Frame: 6 and 12 months post randomisation ] [ Designated as safety issue: No ]
    Patient reported outcome related to neuropathic pain

  • Quantitative Sensory Testing [ Time Frame: 6 and 12 months post randomisation ] [ Designated as safety issue: No ]
    Clinical assessment of pain and pain thresholds

  • Health Economics - EQ5D [ Time Frame: 6 and 12 months post randomisation ] [ Designated as safety issue: No ]
    Patient reported expenditure and quality of life questions

  • Complications [ Time Frame: 6 and 12 months post randomisation ] [ Designated as safety issue: No ]
    Patient reported complications post randomisation

  • Treatment Expectations and Satisfaction [ Time Frame: 6 and 12 months post randomisation ] [ Designated as safety issue: No ]
    Patient reported questions on treatment expectations and satisfaction with treatment.

  • Hospital Anxiety and Depression Scale [ Time Frame: 6 and 12 months post randomisation ] [ Designated as safety issue: No ]
    Patient reported questionnaire related to their feelings of anxiety and depression.

  • Patient Response Shift [ Time Frame: 12 months post randomisation ] [ Designated as safety issue: No ]
    patient response shift on perceived disability will be assessed by comparing each patients pre-operative self-evaluation of their disability (baseline Oxford Shoulder Score) with a 12 month evaluation of their perceived pre-intervention state (the "thentest") according to the method of Razmjou et al (2010. This will give an indication of whether patients with sub-acromial pain underrate or overrate their pre-intervention disability according to their outcome.


Estimated Enrollment: 300
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arthroscopic Sub-acromial Decompression
Arthroscopic sub-acromial decompression surgery.
Procedure: Arthroscopic Sub-acromial Decompression Surgery
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.
Other Name: ASAD
Active Comparator: Shoulder Arthroscopy
Shoulder arthroscopy only.
Procedure: Shoulder Arthroscopy
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.
Other Name: Arthroscopy alone
Active Monitoring with Specialist Reassessment
Active monitoring with specialist reassessment - non-operative control.
Other: Active Monitoring with Specialist Reassessment
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.
Other Names:
  • Non-operative group
  • Control group

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623011

Contacts
Contact: Naomi Cummings 01865 737643 naomi.cummings@ndorms.ox.ac.uk
Contact: Cushla Cooper 01865 737643 cushla.cooper@ndorms.ox.ac.uk

Locations
United Kingdom
Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7LD
Contact: Naomi Cummings    01865 737643    naomi.cummings@ndorms.ox.ac.uk   
Contact: Cushla Cooper    01865 737643    cushla.cooper@ndorms.ox.ac.uk   
Principal Investigator: Andrew Carr         
Sub-Investigator: Jonathan Rees         
Sponsors and Collaborators
University of Oxford
Arthritis Research UK
University of Aberdeen
Investigators
Study Chair: David J Beard, Professor University of Oxford
Study Chair: Andrew J Carr, Professor University of Oxford
Principal Investigator: 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
  More Information

Additional Information:
No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01623011     History of Changes
Other Study ID Numbers: CSAW
Study First Received: June 15, 2012
Last Updated: January 17, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
Shoulder
Sub-acromial
Rotator Cuff
Impingement

Additional relevant MeSH terms:
Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 17, 2014