Comparison between the Manometric brace and conventional plaster braces for patients with osteoarthritis of the trapeziometacarpal joint: a randomised crossover trial

Completed

Conditions: Osteoarthritis
degenerative joint disease
10023213

Registration Number: NL-OMON48108

Lead Sponsor: Reinier de Graaf Groep

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 52

Inclusion Criteria

- Clinical and radiological diagnosis osteoarthritis (OA) in the TMC joint
- OA grade 1, 2 or 3 (according to the Kellgren-Lawrence classification system)
- Age *18
- Signed informed consent
- Sufficiently able to understand Dutch, In case of bilateral TMC OA, patients
who only need a brace for one hand are included, or if they are willing to wait
till after the study for a brace for their second hand. The most symptomatic
side is included in the study, based on clinical and radiological assessment.

Exclusion Criteria

- Disease in the affected hand or wrist other than TMC OA that may interfere
with treatment or bias the study outcome (OA in radiocarpal joints, underlying
inflammatory rheumatic disease, neurovascular disorder affecting the upper
limb, fracture in the past 6 months, significant hand injuries)
- Other (current) therapy for TMC OA (corticosteroid injection in the past 6
months, surgery in the affected TMC joint)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Patient satisfaction, the primary outcome, is measured using the validated<br /><br>Dutch version of the Quebec User Evaluation of Satisfaction with Assistive<br /><br>Technology (D-QUEST). Since no literature is published yet about the minimally<br /><br>clinically important difference for the D-QUEST, we defined a value for<br /><br>ourselves. A difference in score on the D-QUEST of more than 10%, this means<br /><br>0.5 point difference on the 5-point outcome score, was considered to be the<br /><br>margin of clinical significance in this study.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes includes pain, measured by a 10-cm visual analogue scale<br /><br>(VAS), and hand function, measured in terms of grip and pinch strength. In<br /><br>addition, hand function and symptoms are assessed using the Dutch version of<br /><br>the QuickDASH. Compliance is quantified by the wearing time per day in hours,<br /><br>reported using a self-reported diary of each patient. At the end of the two<br /><br>treatment periods, patient preference for one of the two braces is asked. </p><br>