Thumb Osteoarthritis
Conditions
Keywords
exercise, orthosis
Brief summary
THIS TRIAL WAS PROSPECTIVELY REGISTERED ON FEBRUARY 27, 2020 IN THE DUTCH TRIAL REGISTRY (www.trialregister.nl), BUT THIS TRIAL REGISTRY WAS TERMINATED. THE DATA ON OUR TRIAL WERE TRANSFERED BY THE DUTCH TRIAL REGISTRY TO WHO'S CLINICAL TRIALS SEARCH PORTAL (REFERENCE NUMBER: NL-OMON54664). WE ALSO REGISTERED THE TRIAL HERE AT CLINICALTRIALS.GOV TO BE ABLE TO ADD MORE DETAILS ON OUR STUDY. Summary: OBJECTIVE(S)/RESEARCH QUESTION(S) Does an orthosis combined with exercise therapy results in less pain and less conversion to surgery than an orthosis alone in patients with first carpometacarpal osteoarthritis (CMC-1 OA), at three months and one year after the start of treatment? HYPOTHESIS The investigators hypothesize that the orthosis + exercise therapy group has less pain and conversion to surgery will be lower than the orthosis group. STUDY DESIGN Randomized controlled multicenter trial STUDY POPULATION(S)/DATASETS Patients with first carpometacarpal osteoarthritis (CMC-1 OA) seeking treatment INTERVENTION Orthosis + exercise therapy USUAL CARE/COMPARISON Orthosis only OUTCOME MEASURES Primary outcomes: pain and conversion to surgery SAMPLE SIZE CALCULATION/DATA ANALYSIS Two groups of 80 participants; analysis based on repeated measures analysis (for pain) and Chi-square tests (for conversion to surgery). The investigators initially planned to perform a survival analysis (log-rank) and logistic regression for conversion to surgery but decided prior to data analysis on using chi-square tests to determine whether there is a between-group difference in the proportion of conversion to surgery. The investigators made this decision due to low inclusion rates, as chi-square tests require smaller sample sizes. The investigators will use a mixed-effect model analysis for pain. COST-EFFECTIVENESS ANALYSIS (CEA)/ BUDGET IMPACT ANALYSIS (BIA) Economic evaluation will be done from societal & healthcare perspectives, according cost-effectiveness analysis (CEA) guidelines. Medical & non-medical costs and consequences (i.e. productivity loss) will be collected and taken into account. Both CEA and cost-utility analysis will be performed, using conversion to surgery and Quality-adjusted life years (QALYs), respectively TIME SCHEDULE Start preparation: December 2019, inclusion: October 2020- December 2022, final report: December 2023
Interventions
The orthosis + exercise group receives the same orthosis and instructions as the orthosis group (see next section), supplemented by exercise therapy. This includes weekly 25-30-minute physical therapy sessions with a total of 12 sessions. Sessions include patient education on thumb positioning, functional training and home exercise instructions to improve CMC-1 stability during pinch in extension/abduction, as instability and degeneration occurs in flexion/adduction(17,19,28-31). The first phase (week 0 - week 6) comprises coordination exercises for the thumb intrinsics (except adductor pollicis), extensor pollicis brevis and first dorsal interosseous to support CMC-1 extension/abduction. The second phase (week 6 - month 3) comprises reduced orthosis usage and thenar muscle strengthening exercises(except adductor pollicis).
OTHEROrthosis
The orthosis group receives a custom-made thermoplastic orthosis immobilizing the first carpometacarpal joint (CMC-1) in extension/abduction and the metacarpophalangeal joint in flexion. Orthosis usage is 24/7 in the first two weeks, thereafter only during activities with high load until three months. Two appointments take place: one for orthosis fabrication and one for a one-week checkup.
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Xpert Clinics
Franciscus Gasthuis
IJsselland ziekenhuis
Reinier Haga Orthopedisch Centrum
Elisabeth-TweeSteden Ziekenhuis
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All participants must meet the following criteria: 1) aged 18 or older; 2) Eaton stage 2-4 first carpometacarpal osteoarthritis (CMC-1 OA) based on radiographics and/or clinical examination; and 3) ability to visit the treatment center for treatment sessions.
Exclusion criteria
A potential participant that meets any of the following criteria will be excluded: 1) secondary first carpometacarpal osteoarthritis (CMC-1 OA) (e.g., due Bennett's fracture); 2) presence of comorbidity that interferes with treatment or outcome (e.g., carpal tunnel syndrome or De Quervain tenosynovitis); 3) surgery in medical history that interferes with treatment or outcome (e.g., trapeziectomy or tendon repair); 4) steroid injection in hand/wrist \<6 weeks prior to admission; 5) previous treatment for CMC-1 OA in one of both hands, including orthosis, hand therapy or surgery; or 6) insufficient ability to understand written and spoken Dutch or English language.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain - change | 3 months (primary), other Time points: baseline, 6 weeks, 6 months, 1 year. | Michigan Hand Outcomes Questionnaire |
| Conversion to surgical treatment | 12 months | Questionnaire: surgery yes/no |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life | Time points: baseline, 6 weeks, 3 months, 6 months, 1 year. | EuroQol-5-Dimension-5-levels |
| Hand Function | Time points: baseline, 6 weeks, 3 months, 6 months, 1 year. | Michigan Hand Outcomes Questionnaire |
| Satisfaction with treatment results | Time points: 6 weeks, 3 months, 6 months, 1 year. | Satisfaction with Treatment Result Questionnaire |
| Return to work | Time points: 6 weeks, 3 months, 6 months, 9 months, 1 year. | Return to work |
| Grip & Pinch strength | Time points: baseline, 6 weeks, 3 months, 6 months, 1 year. | Hand-held dynamometer and Pinch |
| Complications | Time points: baseline, 6 weeks, 3 months, 6 months, 1 year. | ICHOM Modified Clavien-Dindo Classification |
| Costs and productivity loss | Time points: 6 weeks, 3 months, 6 months, 9 months, 1 year. | Productivity Cost Questionnaire, Medical Consumption Questionnaire |
| Range of motion | Time points: baseline, 6 weeks, 3 months, 6 months, 1 year. | Goniometry and Kapandji Score |
| Treatment credibility and expectations | Time points: baseline, 6 weeks. | Credibility/Expectancy Questionnare |
| Perceived attention/quality of the relationship | Time points: 6 weeks, 3 months. | Consultation and Relational Empathy Measure |
| Depression | Time points: baseline,3 months. | Patient Health Questionnaire-9 |
| Anxiety | Time points: baseline, 3 months. | General Anxiety Disorder-7 |
| Illness perception | Time points: baseline, 3 months. | Brief Illness Perception Questionnaire |
| Pain catastrophizing | Time points: baseline. | Pain Catasctriphizing Scale |
| Treatment adherence | Time points: 6 wks, 3 months | Therapy Adherence Assessment Tool |
| Experience with healthcare delivery | Time points: 6 weeks, 3 months. | Patient Reported Experience Measure |
Countries
Netherlands
Outcome results
None listed