Transmural project for subacromial impingement syndrome: a randomized controlled trial comparing a new transmural treatment strategy (TRANSIT) with usual medical care
- Conditions
- Subacromial impingement syndromeMusculoskeletal Diseases
- Registration Number
- ISRCTN58108023
- Lead Sponsor
- niversity Medical Center Groningen (UMCG), Department Orthopaedic Surgery (The Netherlands)
- Brief Summary
2007 Protocol article in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17316441 Study protocol:
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 70
1. Pain on abduction of the shoulder
2. Shoulder pain as a recurrence of an episode with a maximum duration of 12 months in which a partial or good response is achieved with (a) subacromial corticosteroid injection(s)
3. A maximum duration of three months of shoulder complaints prior to the first subacromial injection, possibly treated with non-steroidal anti-inflammatory drug (NSAID) and/or physiotherapy
4. No shoulder complaints for at least two years prior to the current episode of shoulder pain
5. Men and women, aged between 30 and 60 years
6. Being able to give an informed consent
Amendment to inclusion criterion number 3 as of 24/07/2006:
3. A maximum duration of six months of shoulder complaints prior to the first subacromial injection, possibly treated with non-steroidal anti-inflammatory drug (NSAID) and/or physiotherapy
1. Shoulder girdle pain
2. Shoulder pain not based on pain on abduction of the shoulder
3. Signs of cervical root compression
4. Bilateral shoulder pain
5. Secondary subacromial impingement
6. Presence of specific rheumatic diseases
7. History of severe trauma of the shoulder (fracture or luxation)
8. Previous surgery of the affected shoulder
9. Extrinsic causes of shoulder pain
10. Presence of dementia of other psychiatric disorders
11. Not being able to fill in questionnaires in Dutch
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Shoulder Disability Questionnaire: a 16-item measure for functional status limitation in patients with shoulder disorders (Van der Heijden et al, 2000).<br> Study data will be collected at the following moments: at inclusion, at randomization and three, six and twelve months after randomization.<br>
- Secondary Outcome Measures
Name Time Method