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Thumb OsteoarthritisTHETANCT05772715

The THumb Osteoarthritis Exercise TriAl

A study testing orthosis + exercise therapy and Orthosis in people with Thumb Osteoarthritis, run by Erasmus Medical Center at 5 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thumb Osteoarthritis
What is being tested?
orthosis + exercise therapy and Orthosis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
5 sitesNetherlands
Study dates
1 Sep 2020to 15 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Netherlands5 sites

  • IJsselland ziekenhuis

    Capelle aan den IJssel, South Holland, 2906 ZC

  • Xpert Clinics (multiple sites)

    Eindhoven, North Brabant, 5657 DD

  • Franciscus Gasthuis

    Rotterdam, South Holland, 3045 PM

  • Elizabeth-TweeSteden Ziekenhuis

    Tilburg, North Brabant, 5042AD

  • Reinier Haga Orthopedisch Centrum

    Zoetermeer, South Holland, 2725 NA

Other trials in Netherlands

About this study

Official 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

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:

Read more

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 \&amp; healthcare perspectives, according cost-effectiveness analysis (CEA) guidelines. Medical \&amp; 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

Being tested
orthosis + exercise therapy, Orthosis
Keywords
exercise, orthosis
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • orthosis + exercise therapyOther

    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).

  • OrthosisOther

    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.

Study groups in NCT05772715
Study groupRoleWhat they receive
Orthosis groupActive comparatorNot described
Receives: Other: Orthosis
Orthosis + exercise groupExperimentalNot described
Receives: Other: orthosis + exercise therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain - change

    Michigan Hand Outcomes Questionnaire

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

  2. Conversion to surgical treatment

    Questionnaire: surgery yes/no

    Measured: 12 months

Secondary outcomes (16)

  1. Health-related quality of life

    EuroQol-5-Dimension-5-levels

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

  2. Hand Function

    Michigan Hand Outcomes Questionnaire

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

  3. Satisfaction with treatment results

    Satisfaction with Treatment Result Questionnaire

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

  4. Return to work

    Return to work

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

  5. Grip & Pinch strength

    Hand-held dynamometer and Pinch

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

  6. Range of motion

    Goniometry and Kapandji Score

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

  7. Experience with healthcare delivery

    Patient Reported Experience Measure

    Measured: Time points: 6 weeks, 3 months.

  8. Complications

    ICHOM Modified Clavien-Dindo Classification

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

  9. Costs and productivity loss

    Productivity Cost Questionnaire, Medical Consumption Questionnaire

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

  10. Treatment adherence

    Therapy Adherence Assessment Tool

    Measured: Time points: 6 wks, 3 months

  11. Treatment credibility and expectations

    Credibility/Expectancy Questionnare

    Measured: Time points: baseline, 6 weeks.

  12. Perceived attention/quality of the relationship

    Consultation and Relational Empathy Measure

    Measured: Time points: 6 weeks, 3 months.

  13. Depression

    Patient Health Questionnaire-9

    Measured: Time points: baseline,3 months.

  14. Anxiety

    General Anxiety Disorder-7

    Measured: Time points: baseline, 3 months.

  15. Illness perception

    Brief Illness Perception Questionnaire

    Measured: Time points: baseline, 3 months.

  16. Pain catastrophizing

    Pain Catasctriphizing Scale

    Measured: Time points: baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2023
  2. Study start1 Sep 2020
  3. Primary completion30 Nov 2023
  4. Study completion15 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05772715
Sponsor's protocol ID
852002001
Acronym
THETA
Status last verified
Nov 2024
First submitted
23 Dec 2022
Last updated
18 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will manage the data following FAIR principles and store the data in DANS

Publications

  • Wouters RM, Esteban Lopez LM, Heemskerk SC, Bierma-Zeinstra SM, Kraan GA, Colaris J, Zuidam JM, Vermeulen GM, Selles RW; THETA Study Group Collaborators. Effectiveness of exercise therapy in patients with thumb carpometacarpal osteoarthritis: A multicenter, randomized controlled trial. Osteoarthritis Cartilage. 2026 May;34(5):679-690. doi: 10.1016/j.joca.2025.10.005. Epub 2025 Oct 23.

    PubMed 41138847

Questions about this trial

What is this clinical trial studying?

A study testing orthosis + exercise therapy and Orthosis in people with Thumb Osteoarthritis, run by Erasmus Medical Center at 5 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain - change (time frame: 3 months (primary), other Time points: baseline, 6 weeks, 6 months, 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05772715, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.

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