Thumb Osteoarthritis Clinical Trial
— THETAOfficial title:
The THumb Osteoarthritis Exercise TriAl (THETA); a Multicenter, Randomized Controlled Trial on Exercise Therapy With an Orthosis Compared to an Orthosis Alone in Patients With Thumb Base Osteoarthritis
Verified date | February 2024 |
Source | Erasmus Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 We 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 irst 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-squared (for conversion to surgery). We initially planned to perform a logistic regression for conversion to surgery but decided prior to data analysis that we will be using Chi-square tests to determine whether there is a between-group difference in the proportion converting to surgery. We will use a repeated measures 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
Status | Completed |
Enrollment | 166 |
Est. completion date | February 15, 2024 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | IJsselland ziekenhuis | Capelle Aan Den IJssel | Zuid-Holland |
Netherlands | Xpert Clinics (multiple sites) | Eindhoven | Noord-Brabant |
Netherlands | Franciscus Gasthuis | Rotterdam | Zuid-Holland |
Netherlands | Elizabeth-TweeSteden Ziekenhuis | Tilburg | Noord-Brabant |
Netherlands | Reinier Haga Orthopedisch Centrum | Zoetermeer | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center | Elisabeth-TweeSteden Ziekenhuis, Franciscus Gasthuis, IJsselland ziekenhuis, Reinier Haga Orthopedisch Centrum, Xpert Clinics, ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain - change | Michigan Hand Outcomes Questionnaire | 3 months (primary), other Time points: baseline, 6 weeks, 6 months, 1 year. | |
Primary | Conversion to surgical treatment | Questionnaire: surgery yes/no | 12 months | |
Secondary | Health-related quality of life | EuroQol-5-Dimension-5-levels | Time points: baseline, 6 weeks, 3 months, 6 months, 1 year. | |
Secondary | Hand Function | Michigan Hand Outcomes Questionnaire | Time points: baseline, 6 weeks, 3 months, 6 months, 1 year. | |
Secondary | Satisfaction with treatment results | Satisfaction with Treatment Result Questionnaire | Time points: 6 weeks, 3 months, 6 months, 1 year. | |
Secondary | Return to work | Return to work | Time points: 6 weeks, 3 months, 6 months, 9 months, 1 year. | |
Secondary | Grip & Pinch strength | Hand-held dynamometer and Pinch | Time points: baseline, 6 weeks, 3 months, 6 months, 1 year. | |
Secondary | Range of motion | Goniometry and Kapandji Score | Time points: baseline, 6 weeks, 3 months, 6 months, 1 year. | |
Secondary | Experience with healthcare delivery | Patient Reported Experience Measure | Time points: 6 weeks, 3 months. | |
Secondary | Complications | ICHOM Modified Clavien-Dindo Classification | Time points: baseline, 6 weeks, 3 months, 6 months, 1 year. | |
Secondary | Costs and productivity loss | Productivity Cost Questionnaire, Medical Consumption Questionnaire | Time points: 6 weeks, 3 months, 6 months, 9 months, 1 year. | |
Secondary | Treatment adherence | Therapy Adherence Assessment Tool | Time points: 6 wks, 3 months | |
Secondary | Treatment credibility and expectations | Credibility/Expectancy Questionnare | Time points: baseline, 6 weeks. | |
Secondary | Perceived attention/quality of the relationship | Consultation and Relational Empathy Measure | Time points: 6 weeks, 3 months. | |
Secondary | Depression | Patient Health Questionnaire-9 | Time points: baseline,3 months. | |
Secondary | Anxiety | General Anxiety Disorder-7 | Time points: baseline, 3 months. | |
Secondary | Illness perception | Brief Illness Perception Questionnaire | Time points: baseline, 3 months. | |
Secondary | Pain catastrophizing | Pain Catasctriphizing Scale | Time points: baseline. |
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