Subacromial pain and suspected partial-thickness rotator cuff tear Injury, Occupational Diseases, Poisoning Injury of muscle(s) and tendon(s) of the rotator cuff of shoulder
Conditions
Interventions
PRoCuRe is a randomised controlled trial with 1:1 allocation. Patient eligibility for randomisation will be confirmed during surgery. Eligible patients will be randomised in theatre to receive one of
online or on paper according to participant preference. At the 5-year timepoint, as well as asking participants to complete a questionnaire, the researchers will request routine information on further
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Over 18 years of age 2. Willing and able to provide informed consent 3. MRI or USS suggesting a Partial Thickness Tear (PTT) diagnosis is Supraspinatus 4. An understanding of the English language sufficient to receive written and verbal information about the trial, its consent process and complete study questionnairesMRI or USS suggesting a PTT diagnosis in Supraspinatus Inclusion Criteria for randomisation (confirmed in surgery) 5. PTT more than 50% tendon thickness confirmed in Supraspinatus during arthroscopy
Exclusion criteria
Exclusion criteria: 1. Patient has not had 6 months of physiotherapy 2. Patient has not had at least one steroid injection 3. Steroid injection within 6 weeks of planned surgery date 4. No Partial Thickness Tear (PTT) 5. PTT less than 50% tendon thickness 6. Any full-thickness tears on imaging or at surgery 7. Inflammatory arthritis (e.g. rheumatoid) 8. Glenohumeral osteoarthritis 9. Current active malignancy of any kind 10. Tears associated with acute fractures 11. Tears associated with shoulder dislocations 12. Upper limb neurological deficit on either side 13. Unable to undergo MRI 14. Unable to complete the written follow-up questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain and function measured using the Oxford Shoulder Score (OSS) at 24 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain and function measured using the Oxford Shoulder Score (OSS) at baseline, 6, 12 months, and 5 years post-randomisation 2. Quality of life measured using EQ-5D-5L at baseline, 6, 12, 24 months and 5 years post-randomisation 3. Patient use of health resources assessed using a health resource use questionnaire at 6, 12, and 24 months post-randomisation 4. Patient satisfaction and perception assessed using satisfaction and perception questionnaire at 6, 12, and 24 months post-randomisation 5. Progression to full-thickness cuff tears assessed through MRI imaging at 24 months post-randomisation 6. Readmission for further surgery and associated costs assessed by routinely collected observational hospital data (HES) at 5 years post-randomisation | — |
Countries
England, United Kingdom
Contacts
Public ContactSITU-NDORMS Team
Outcome results
None listed