Effectiveness of Trapeziometacarpal Splint

Osteoarthritis of Trapeziometacarpal Joint Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02635932
• Other study ID #: CEP_UNIFESP_269.012
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: March 2017

Study information

• Verified date: December 2022
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of Trapeziometacarpal Joint

Intervention

Device:
• Day Splint
A thermoplastic splint was confected for each participant to stabilize the trapeziometacarpal joint, maintaining the pulp of the distal phalange of the index finger free for gripping with the other fingers and leaving the thumb in a functional position. In this group the slint was used during the daily life activities.
• Night Splint
A thermoplastic splint was confected for each participant to stabilize the trapeziometacarpal joint, maintaining the pulp of the distal phalange of the index finger free for gripping with the other fingers and leaving the thumb in a functional position. In this group the slint was used during the night.

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo - Rheumatology Division	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain scale		baseline, after 45, 90 and 180 days
Secondary	Change in Functional capacity using the Cochin Hand Functional Scale questionnaire		baseline, after 45, 90 and 180 days
Secondary	Change in pinch and grip strength		baseline, after 45, 90 and 180 days