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Sponsors and Collaborators: |
Federal University of São Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo |
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Information provided by: | Federal University of São Paulo |
ClinicalTrials.gov Identifier: | NCT00612248 |
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.
Condition | Intervention | Phase |
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Osteoarthritis |
Other: Splint |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Assessment of the Effectiveness of a Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint on the Dominant Hand: A Randomized Controlled Study |
Enrollment: | 40 |
Study Start Date: | July 2005 |
Study Completion Date: | December 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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SG: Experimental
Study group
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Other: Splint
Patients in the study group received the splint on the day of the first evaluation and took it with them for use during activities of daily living and patients in the control group only used the splint during the evaluations
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CG: No Intervention
Control group
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Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | UNIFESP - Universidade Federal de Sao Paulo ( Ana Claudia Gomes Carreira ) |
Study ID Numbers: | UNIFESP0108, CEP1090/03 |
Study First Received: | January 29, 2008 |
Last Updated: | January 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00612248 |
Health Authority: | Brazil: National Committee of Ethics in Research |
Osteoarthritis Thumb Splint |
Pain Function Osteoarthritis of the trapeziometacarpal (TMC) joint |
Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Pain Rheumatic Diseases |