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Manometric TMC brace: a randomised crossover trial

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20275
Enrollment
52
Registered
2018-10-10
Start date
2019-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, duimartrose

Interventions

Patients will receive both the Manometric and the plaster brace for four weeks. Between the two treatment periods is a one-week washout period.

Sponsors

Department of orthopedics, Reinier de Graaf hospital
Lead Sponsor

Eligibility

Inclusion criteria

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). - 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 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) - Insufficient knowledge of the Dutch language - Mental illness

Design outcomes

Primary

MeasureTime 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, is considered to be the margin of clinical significance in this study.

Secondary

MeasureTime 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.

Contacts

Public ContactG. Kraan

Reinier de Graaf Groep

KraanG@rdgg.nl+31 (0)15 260 3197

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)