Recruiting 1/1/2008 - 12/31/2008
A Clinical Trial of Hand Therapy for Scleroderma
Design: Randomized controlled trial
Patient Selection Criteria
Inclusion criteria:
1. Have a diagnosis of systemic sclerosis according to
classification criteria of the American College of Rheumatology.
2. Diagnosis of 3 years duration or less. Diagnosis is dated from
the onset of the first non-Raynaud manifestation that is confidently
recognized as a feature of systemic sclerosis.
3. Have hand impairment judged in need of therapy by study physician
and/or occupational therapist. This is further defined as having
grip strength of 20 pounds or less and inability to make a complete
fist.
4. Both the subject and the subject’s clinician must agree not to
engage in hand therapy during the protocol period other than that
provided by the protocol.
5. Be able to attend weekly occupational therapy sessions at the
University of Michigan for a period of 3 months.
6. Have insurance coverage for occupational therapy.
7. Read and write English.
Exclusion criteria:
1. Active hand infection.
2. Ischemic digit or established demarcated proximal digital
gangrene.
3. Anticipated need for hand surgery within the next 6 months.
4. Unstable systemic disease, e.g. new onset of scleroderma renal
crisis.
Outcome Measures
Primary: To test the
effectiveness of Standardized Occupational Hand Therapy in treating
hand deformities associated with Systemic Sclerosis.
Secondary: To assess the responsiveness of the Michigan Hand
Outcomes Questionnaire (MHQ) in this patient population and to
compare it to standard hand function tests.
Completion: 6/1/2009
Date of Expected Analysis: 1/1/2009