An interventional study of orthosis + exercise therapy and Orthosis in Thumb Osteoarthritis, sponsored by Erasmus Medical Center. Completed at 5 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Treatment
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
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 166 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
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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.
Other: Orthosis
Other: orthosis + exercise therapy
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).
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.
Pain - change
Michigan Hand Outcomes Questionnaire
Time frame: 3 months (primary), other Time points: baseline, 6 weeks, 6 months, 1 year.
Conversion to surgical treatment
Questionnaire: surgery yes/no
Time frame: 12 months
Health-related quality of life
EuroQol-5-Dimension-5-levels
Time frame: Time points: baseline, 6 weeks, 3 months, 6 months, 1 year.
Hand Function
Michigan Hand Outcomes Questionnaire
Time frame: Time points: baseline, 6 weeks, 3 months, 6 months, 1 year.
Satisfaction with treatment results
Satisfaction with Treatment Result Questionnaire
Time frame: Time points: 6 weeks, 3 months, 6 months, 1 year.
Return to work
Return to work
Time frame: Time points: 6 weeks, 3 months, 6 months, 9 months, 1 year.
Grip & Pinch strength
Hand-held dynamometer and Pinch
Time frame: Time points: baseline, 6 weeks, 3 months, 6 months, 1 year.
Range of motion
Goniometry and Kapandji Score
Time frame: Time points: baseline, 6 weeks, 3 months, 6 months, 1 year.
Experience with healthcare delivery
Patient Reported Experience Measure
Time frame: Time points: 6 weeks, 3 months.
Complications
ICHOM Modified Clavien-Dindo Classification
Time frame: Time points: baseline, 6 weeks, 3 months, 6 months, 1 year.
Costs and productivity loss
Productivity Cost Questionnaire, Medical Consumption Questionnaire
Time frame: Time points: 6 weeks, 3 months, 6 months, 9 months, 1 year.
Treatment adherence
Therapy Adherence Assessment Tool
Time frame: Time points: 6 wks, 3 months
Treatment credibility and expectations
Credibility/Expectancy Questionnare
Time frame: Time points: baseline, 6 weeks.
Perceived attention/quality of the relationship
Consultation and Relational Empathy Measure
Time frame: Time points: 6 weeks, 3 months.
Depression
Patient Health Questionnaire-9
Time frame: Time points: baseline,3 months.
Anxiety
General Anxiety Disorder-7
Time frame: Time points: baseline, 3 months.
Illness perception
Brief Illness Perception Questionnaire
Time frame: Time points: baseline, 3 months.
Pain catastrophizing
Pain Catasctriphizing Scale
Time frame: Time points: baseline.
Plan to share: Yes — We will manage the data following FAIR principles and store the data in DANS
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Erasmus Medical Center