Transmural project for subacromial impingement syndrome: a randomized controlled trial comparing a new transmural treatment strategy (TRANSIT) with usual medical care.
- Conditions
- Subacromial impingement syndrome.
- Registration Number
- NL-OMON22906
- Lead Sponsor
- Department Orthopaedic SurgeryUniversity Medical Center Groningen
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- 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 six months of shoulder complaints prior to the first subacromial injection, possibly treated with 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, age between 30 and 60 years;
6. Being able to give an informed consent.
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 Shoulder Disability Questionnaire: a 16-item measure for functional status limitation in patients with shoulder disorders (Van der Heijden e.a., 2000).<br>Study data will be collected at the following moments: at inclusion, at randomization and three, six and twelve months after randomization.
- Secondary Outcome Measures
Name Time Method