Osteoarthritis
Conditions
Interventions
Patients will wear both the Manometric brace and the plaster brace for four
weeks. A washout period of 1 week is between the treatment periods.
Sponsors
Reinier de Graaf Groep
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient satisfaction, the primary outcome, is measured using the validated Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST). Since no literature is published yet about the minimally clinically important difference for the D-QUEST, we defined a value for ourselves. A difference in score on the D-QUEST of more than 10%, this means 0.5 point difference on the 5-point outcome score, was considered to be the margin of clinical significance in this study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes includes pain, measured by a 10-cm visual analogue scale (VAS), and hand function, measured in terms of grip and pinch strength. In addition, hand function and symptoms are assessed using the Dutch version of the QuickDASH. Compliance is quantified by the wearing time per day in hours, reported using a self-reported diary of each patient. At the end of the two treatment periods, patient preference for one of the two braces is asked. | — |
Countries
Netherlands
Outcome results
None listed