Effectiveness of Trapeziometacarpal Splint

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of Trapeziometacarpal Joint
• Intervention / Treatment: Device: Day Splint; Device: Night Splint

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04023-900
      • Federal University of Sao Paulo - Rheumatology Division

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional Splint group; Patient will be using the functional splint during their activity daily life	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.
Active Comparator: Night Splint group; Patients will use the night splint during the sleep time	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in pain scale	baseline, after 45, 90 and 180 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: December 13, 2015
• First Submitted That Met QC Criteria: December 16, 2015
• First Posted (Estimate): December 21, 2015

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: CEP_UNIFESP_269.012