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Completed

NCT Number: NCT05772715

The THumb Osteoarthritis Exercise TriAl

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

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Key information

Conditions

Thumb Osteoarthritis Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xpert Clinics (multiple sites), Eindhoven, North Brabant, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

orthosis + exercise therapy

Other

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).

Orthosis

Other

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.

Primary outcomes

  1. Pain - change

    Time frame: 3 months (primary), other Time points: baseline, 6 weeks, 6 months, 1 year.

    Michigan Hand Outcomes Questionnaire

  2. Conversion to surgical treatment

    Time frame: 12 months

    Questionnaire: surgery yes/no

Secondary outcomes

  1. Health-related quality of life

    Time frame: Time points: baseline, 6 weeks, 3 months, 6 months, 1 year.

    EuroQol-5-Dimension-5-levels

  2. Hand Function

    Time frame: Time points: baseline, 6 weeks, 3 months, 6 months, 1 year.

    Michigan Hand Outcomes Questionnaire

  3. Satisfaction with treatment results

    Time frame: Time points: 6 weeks, 3 months, 6 months, 1 year.

    Satisfaction with Treatment Result Questionnaire

  4. Return to work

    Time frame: Time points: 6 weeks, 3 months, 6 months, 9 months, 1 year.

    Return to work

  5. Grip & Pinch strength

    Time frame: Time points: baseline, 6 weeks, 3 months, 6 months, 1 year.

    Hand-held dynamometer and Pinch

  6. Range of motion

    Time frame: Time points: baseline, 6 weeks, 3 months, 6 months, 1 year.

    Goniometry and Kapandji Score

  7. Experience with healthcare delivery

    Time frame: Time points: 6 weeks, 3 months.

    Patient Reported Experience Measure

  8. Complications

    Time frame: Time points: baseline, 6 weeks, 3 months, 6 months, 1 year.

    ICHOM Modified Clavien-Dindo Classification

  9. Costs and productivity loss

    Time frame: Time points: 6 weeks, 3 months, 6 months, 9 months, 1 year.

    Productivity Cost Questionnaire, Medical Consumption Questionnaire

  10. Treatment adherence

    Time frame: Time points: 6 wks, 3 months

    Therapy Adherence Assessment Tool

  11. Treatment credibility and expectations

    Time frame: Time points: baseline, 6 weeks.

    Credibility/Expectancy Questionnare

  12. Perceived attention/quality of the relationship

    Time frame: Time points: 6 weeks, 3 months.

    Consultation and Relational Empathy Measure

  13. Depression

    Time frame: Time points: baseline,3 months.

    Patient Health Questionnaire-9

  14. Anxiety

    Time frame: Time points: baseline, 3 months.

    General Anxiety Disorder-7

  15. Illness perception

    Time frame: Time points: baseline, 3 months.

    Brief Illness Perception Questionnaire

  16. Pain catastrophizing

    Time frame: Time points: baseline.

    Pain Catasctriphizing Scale

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Elisabeth-TweeSteden Ziekenhuis
  • Franciscus Gasthuis
  • IJsselland Hospital
  • Reinier Haga Orthopedisch Centrum
  • Xpert Clinics
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study 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

Acronym: THETA

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Mar 16, 2023
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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