The THumb osteoarthritis Exercise TriAl (THETA); a multicenter, randomized controlled trial on exercise therapy with an orthosis compared to an orthosis alone in patients with thumb base osteoarthritis

Recruiting

Conditions: thumb basal joint osteoarthritis
thumb carpometacarpal arthritis
10023213

Registration Number: NL-OMON54664

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 160

Inclusion Criteria

In order to be eligible to participate in this study, a participant must meet
all of the following criteria: - Age >= 18 years; - Eaton stage 2-3 CMC-1 OA
based on radiographics & clinical examination; - Ability to visit the
treatment center for treatment sessions.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study: - Secondary CMC-1 OA (e.g., due Bennett*s
fracture); - Presence of comorbidity that interferes with treatment or outcome
(e.g., carpal tunnel syndrome or De Quervain tenosynovitis); - Surgery in
medical history that interferes with treatment or outcome (e.g., trapeziectomy
or tendon repair); - Steroid injection in hand/wrist <6 weeks prior to
admission; - Previous treatment for CMC-1 OA in one of both hands, including
orthosis, hand therapy or surgery; - Insufficient ability to understand written
and spoken Dutch or English language

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcomes: pain and conversion to surgery</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>health-related quality of life, hand function and /ADL, satisfaction with<br /><br>treatment results, return to work, grip & pinch strength, range of motion<br /><br>(ROM), reported experience, psychological factors, and complications</p><br>