Manometric TMC brace: a randomised crossover trial

Completed

Conditions: Osteoarthritis, duimartrose

Registration Number: NL-OMON20275

Lead Sponsor: Department of orthopedics, Reinier de Graaf hospital

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 52

Inclusion Criteria

Clinical and radiological diagnosis of osteoarthritis (OA) in the TMC joint.

- OA grade 1, 2 of 3 (according to the Kellgren-Lawrence classification system).

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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