Effectiveness of Trapeziometacarpal Splint

Federal University of São Paulo

Status: Completed

Conditions: Osteoarthritis of Trapeziometacarpal Joint

Treatments: Device: Night Splint; Device: Day Splint

Study type: Interventional

Funder types: Other

Identifiers

NCT02635932

CEP_UNIFESP_269.012

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Functional Splint group

Experimental group

Description:

Patient will be using the functional splint during their activity daily life

Treatment:

Device: Day Splint

Night Splint group

Active Comparator group

Description:

Patients will use the night splint during the sleep time

Treatment:

Device: Night Splint