Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-12-31

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.

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Detailed Description

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Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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SG

Study group

Group Type EXPERIMENTAL

Splint

Intervention Type OTHER

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

CG

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No