Status:
COMPLETED
Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint
Lead Sponsor:
Federal University of São Paulo
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
Forty participants were enrolled in a randomized, controlled clinical trial to evaluate the effectiveness of a functional thumb splint for trapeziometacarpal OA in the dominant hand.
Detailed Description
Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
Eligibility Criteria
Inclusion
- clinical and radiological diagnosis of idiopathic Grade II and III OA of the TMC joint on the dominant hand;
- either gender;
- over 40 years of age;
- pain in the base of the thumb of the dominant hand greater than three and less than or equal to seven on the 0 to 10-cm visual analogue scale (VAS) for pain.
Exclusion
- severe deformities of the dominant hand that did not allow gripping between the first, second and third fingers;
- deformities of distal interphalangeal joint;
- use of a splint on the thumb in the previous six months;
- surgery on the hand under study in the previous six months or scheduled in the upcoming six months;
- allergy to the splint material;
- incapacity to respond to the questionnaire and perform the tests;
- geographic inaccessibility;
- injections in the hand under study in the previous six months;
- other associated diseases such as carpal tunnel syndrome, fractures in the carpus, tendonitis, chronic inflammatory arthropathy;
- alterations in the use of anti-inflammatory medication and analgesics in the previous three months.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00612248
Start Date
July 1 2005
End Date
December 1 2007
Last Update
February 11 2008
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