NCT02635932

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

8 months

First QC Date

December 13, 2015

Last Update Submit

December 13, 2022

Conditions

Osteoarthritis of Trapeziometacarpal Joint

Outcome Measures

Primary Outcomes (1)

  • Change in pain scale

    baseline, after 45, 90 and 180 days

Secondary Outcomes (2)

  • 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

Study Arms (2)

Functional Splint group

EXPERIMENTAL

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

Device: Day Splint

Night Splint group

ACTIVE COMPARATOR

Patients will use the night splint during the sleep time

Device: Night Splint

Interventions

Day SplintDEVICE

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.

Functional Splint group
Night SplintDEVICE

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.

Night Splint group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo - Rheumatology Division

São Paulo, São Paulo, 04023-900, Brazil

Location

Related Publications (1)

  • Silva FC, da Silva RVT, Meireles SM, Fernandes ADRC, Natour J. Daytime Functional Usage Versus Night-Time Wearing: Identifying the Optimal Wearing Regimen for a Custom-Made Orthosis in the Treatment of Trapeziometacarpal Osteoarthritis. Arch Phys Med Rehabil. 2024 Oct;105(10):1837-1845. doi: 10.1016/j.apmr.2024.06.013. Epub 2024 Jul 4.

    PMID: 38971487DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

December 13, 2015

First Posted

December 21, 2015

Study Start

January 1, 2016

Primary Completion

September 1, 2016

Study Completion

March 1, 2017

Last Updated

December 15, 2022

Record last verified: 2022-12

Locations

BR(1)