nited Kingdom Frozen Shoulder Trial (UK FroST)
- Conditions
- Frozen shoulder (adhesive capsulitis)Musculoskeletal DiseasesAdhesive capsulitis of shoulder
- Registration Number
- ISRCTN48804508
- Lead Sponsor
- South Tees NHS Foundation Trust (UK)
- Brief Summary
2020 results in https://pubmed.ncbi.nlm.nih.gov/33010843/ (added 07/10/2020) 2020 results in https://pubmed.ncbi.nlm.nih.gov/33292924/ (added 10/12/2020) 2021 qualitative results in https://pubmed.ncbi.nlm.nih.gov/34117042/ (added 14/06/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 503
1. Patients with frozen shoulder, including diabetics, >=18 years old
2. Passive external rotation in the affected shoulder that is <50% of the contralateral shoulder
3. Radiographs to exclude secondary causes e.g. glenohumeral arthritis
1. Bilateral concurrent frozen shoulders
2. Secondary to trauma or other causes
3. Trial treatments contraindicated
4. Unfit for general anaesthesia
5. Not resident to trauma catchment area of a participating trial site
6. Lack mental capacity to comply with treatment or data collection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Oxford Shoulder Score (OSS) (12-item condition-specific questionnaire providing a total score based on the person's subjective assessment of pain and activities of daily living impairment) assessed at 3, 6 and 12 months post randomisation. Primary time point is 12 months after randomisation. OSS will also be collected at pre-treatment, as well as 6 months post-treatment
- Secondary Outcome Measures
Name Time Method