Can Shoulder Arthroscopy Work: What is the clinical and cost effectiveness of arthroscopic sub-acromial decompression surgery for patients with sub-acromial Pain?

Not Applicable

Completed

• Conditions: Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal; Musculoskeletal Diseases; Bursitis of shoulder

• Registration Number: ISRCTN33864128
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

2015 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/25956385 results 2018 Results article in https://pubmed.ncbi.nlm.nih.gov/29169668/ (added 12/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-22
• Study Completion: 2017-03-31
• Last Update Posted: 23 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Sub-acromial pain of at least 3 month duration
2. Diagnosis by Consultant of sub-acromial pain or partial thickness rotator cuff tear
3. Has had an Magnetic Resonance Imaging (MRI) or Ultrasound scan to rule out alternative pathology
4. Able to undergo arthroscopic surgery
5. Physiotherapy that includes a remedial exercise regime
6. at least 1 previous cortisone injection but not more than 3
7. Inclusion criteria for the FMRI Sub Study is that they must be able to undergo an MRI scan according to safety regulations outlined in the MRI Safety Questionnaire.; 8. Target Gender: Male & Female; Upper Age Limit 75 years ; Lower Age Limit 35 years

Exclusion Criteria

1. Full thickness rotator cuff tear (diagnosed/eliminated using Ultrasound or MRI)
2. Undergone previous surgery on affected shoulder
3. Diagnosed rheumatoid arthritis or other inflammatory disorder
4. Symptomatic,cervical spine pathology
5. Previous septic arthritis
6. History of radiotherapy on affected shoulder side
7. Patients who have a strong preference for one treatment over another
8. Patients from the Nuffield Orthopaedic Centre, Oxford who are recruited to the main study will be excluded from the Neuroimaging MRI Scans if any of the following MRI contraindications are present:
8.1. Metal in their body, implants (may cause injury to the participant and produce artefacts on MR scans)
8.2. History of severe claustrophobia (may cause discomfort inside the MRI scanner)
8.3. Pregnancy
8.4. Taking medication that may influence brain function

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oxford Shoulder Score; Timepoint(s): 6 months post randomisation

Secondary Outcome Measures

Name	Time	Method
1. Constant Murley Score; Timepoint(s): 6 and 12 months post randomisation<br>2. EQ5D; Timepoint(s): 6 and 12 months post randomisation<br>3. Hospital Anxiety and Depression Scale (HADS) Questionnaire; Timepoint(s): 6 and 12 months post randomisation<br>4. Pain DeTECT Questionnaire; Timepoint(s): 6 and 12 months post randomisation<br>5. Quantitative Sensory Testing; Timepoint(s): 6 and 12 months post randomisation