Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint

Phase 2

Completed

• Conditions: Osteoarthritis
• Interventions: Other: Splint

• Registration Number: NCT00612248
• Lead Sponsor: Federal University of São Paulo

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

Study Timeline

• Study Start: 2005-07
• Primary Completion: 2007-07
• Study Completion: 2007-12
• Status Verified: 2008-01
• Study First Submitted: 2008-01-29
• Study First Submitted QC: 2008-01-29
• Last Update Submitted: 2008-01-29
• Study First Posted: 2008-02-11
• Last Update Posted: 2008-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SG	Splint	Study group

Primary Outcome Measures

Name	Time	Method
Pain (VAS)	baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)

Secondary Outcome Measures

Name	Time	Method
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)