Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint

Study Overview
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Brief Summary
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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
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Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title
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Assessment of the Effectiveness of a Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint on the Dominant Hand: A Randomized Controlled Study

Conditions
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Osteoarthritis

Intervention / Treatment
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* Other: Splint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SG<br>Study group | Other: Splint<br>* 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<br>|
| No Intervention: CG<br>Control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (VAS) |  | baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function (DASH) |  | baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180) | 
| Grip and pinch strength (dynamometer) |  | baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180) | 
| Dexterity (O'Connor test) |  | baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Thumb, Splint, Pain, Function, Osteoarthritis of the trapeziometacarpal (TMC) joint