Shoulder Impingement Syndrome Clinical Trial
— CSAWOfficial title:
What is the Clinical and Cost Effectiveness of Arthroscopic Sub-acromial Decompression Surgery?
Verified date | November 2017 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 300 |
Est. completion date | July 27, 2016 |
Est. primary completion date | December 15, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | Arthritis Research UK, University of Aberdeen |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oxford Shoulder Score | Patient reported outcome measure of shoulder pain and function. | 6 months post randomisation | |
Secondary | Oxford Shoulder Score | Patient reported outcome measure of shoulder pain and function | 12 months post randomisation | |
Secondary | Constant Murley Shoulder Score | Clinical assessment of the shoulder | 6 and 12 months post randomisation | |
Secondary | Pain DeTECT | Patient reported outcome related to neuropathic pain | 6 and 12 months post randomisation | |
Secondary | Quantitative Sensory Testing | Clinical assessment of pain and pain thresholds | 6 and 12 months post randomisation | |
Secondary | Health Economics - EQ5D | Patient reported expenditure and quality of life questions | 6 and 12 months post randomisation | |
Secondary | Complications | Patient reported complications post randomisation | 6 and 12 months post randomisation | |
Secondary | Treatment Expectations and Satisfaction | Patient reported questions on treatment expectations and satisfaction with treatment. | 6 and 12 months post randomisation | |
Secondary | Hospital Anxiety and Depression Scale | Patient reported questionnaire related to their feelings of anxiety and depression. | 6 and 12 months post randomisation | |
Secondary | Patient Response Shift | 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. | 12 months post randomisation |
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