Effectiveness of Trapeziometacarpal Splint

Not Applicable

Completed

• Conditions: Osteoarthritis of Trapeziometacarpal Joint
• Interventions: Device: Night Splint; Device: Day Splint

• Registration Number: NCT02635932
• Lead Sponsor: Federal University of São Paulo

Brief Summary

The trapeziometacarpal osteoarthritis is a degenerative or inflammatory joint that affects the trapeziometacarpal joint (TMC) of the thumb. Its main symptom is pain that leads to difficulty in manual function and decrease the patient's quality of life. Immobilization of TMC thumb joint by bracing has been effective in reducing pain and improving function. Objective: To compare the effectiveness between day and night functional splint for patients with trapeziometacarpal osteoarthritis in improving pain and function

Detailed Description

Randomized clinical trial, and blind where selected 60 patients diagnosed with trapeziometacarpal osteoarthritis.Os patients were assessed by a blinded evaluator at the beginning of treatment and after 45, 90 and 180 days in relation to pain, thumb range of motion, strength hold, tweezers, dexterity, function and satisfaction.

Study Timeline

• Study First Submitted: 2015-12-13
• Study First Submitted QC: 2015-12-16
• Study First Posted: 2015-12-21
• Study Start: 2016-01
• Primary Completion: 2016-09
• Study Completion: 2017-03
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with osteoarthritis in accordance with the American College of Rheumatology classification criteria (ACR); of both genders and age above 18 years; Pain in TMC articulation between 3 and 8 cm in numerical pain scale (END) 10cm

Exclusion Criteria

• Patients with severe deformities in hand with trapeziometacarpal osteoarthritis not possible to achieve pincer movement between the first, second and third fingers
• Deformity of the distal interphalangeal joint (IFD) of the thumb
• Use of splint the thumb in the last six months; Have surgery scheduled on hand for the next six months
• Allergy to the material of the splint
• Inability to respond to the questionnaire and perform the tests
• Geographic inaccessibility
• Infiltration in hand in the previous 3 months
• Changes in the use of anti-inflammatory and analgesic past 3 months
• Physiotherapy in hand over the last 3 months
• Have the following related diseases: carpal tunnel syndrome, carpal fractures of DeQuervain syndrome, tendonitis, fibromyalgia and chronic inflammatory arthropathy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Night Splint group	Night Splint	Patients will use the night splint during the sleep time
Functional Splint group	Day Splint	Patient will be using the functional splint during their activity daily life

Primary Outcome Measures

Name	Time	Method
Change in pain scale	baseline, after 45, 90 and 180 days

Secondary Outcome Measures

Name	Time	Method
Change in Functional capacity using the Cochin Hand Functional Scale questionnaire	baseline, after 45, 90 and 180 days
Change in pinch and grip strength	baseline, after 45, 90 and 180 days

Trial Locations

Locations (1)

Federal University of Sao Paulo - Rheumatology Division; 🇧🇷 Sao Paulo, SP, Brazil