The THumb Osteoarthritis Exercise TriAl

NCT05772715 | Completed DMC

• 1 other identifier: 852002001
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 5

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

Conditions

Thumb Osteoarthritis

Keywords

exercise; orthosis

Outcome Measures

Primary Outcomes (2)

• Pain - change

  Michigan Hand Outcomes Questionnaire

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

• Conversion to surgical treatment

  Questionnaire: surgery yes/no

  12 months

Secondary Outcomes (16)

• Health-related quality of life

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

• Hand Function

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

• Satisfaction with treatment results

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

• Return to work

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

• Grip & Pinch strength

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

Study Arms (2)

Orthosis group

ACTIVE COMPARATOR

Other: Orthosis

Orthosis + exercise group

EXPERIMENTAL

Other: orthosis + exercise therapy

Interventions

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 + exercise group

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.

Orthosis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Erasmus Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Xpert Clinics: collaborator
• Franciscus Gasthuis: collaborator
• IJsselland ziekenhuis: collaborator
• Reinier Haga Orthopedisch Centrum: collaborator
• Elisabeth-TweeSteden Ziekenhuis: collaborator

Study Sites (5)

Xpert Clinics (multiple sites)

Eindhoven, North Brabant, 5657 DD, Netherlands

Location

Elizabeth-TweeSteden Ziekenhuis

Tilburg, North Brabant, 5042AD, Netherlands

Location

IJsselland ziekenhuis

Capelle aan den IJssel, South Holland, 2906 ZC, Netherlands

Location

Franciscus Gasthuis

Rotterdam, South Holland, 3045 PM, Netherlands

Location

Reinier Haga Orthopedisch Centrum

Zoetermeer, South Holland, 2725 NA, Netherlands

Location

Related Publications (1)

• 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. 2025 Oct 23:S1063-4584(25)01187-2. doi: 10.1016/j.joca.2025.10.005. Online ahead of print.

  PMID: 41138847 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Orthotic Devices; Exercise Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Ruud W Selles, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Robbert Wouters

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: March 16, 2023
• Study Start: September 1, 2020
• Primary Completion: November 30, 2023
• Study Completion: February 15, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

NL (5)