The THumb Osteoarthritis Exercise TriAl (THETA)

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:

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

Study Overview

• Status: Completed
• Conditions: Thumb Osteoarthritis
• Intervention / Treatment: Other: Orthosis; Other: orthosis + exercise therapy

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Brabant
    • Eindhoven, Noord-Brabant, Netherlands, 5657 DD
      • Xpert Clinics (multiple sites)
    • Tilburg, Noord-Brabant, Netherlands, 5042AD
      • Elizabeth-Tweesteden Ziekenhuis
  • Zuid-Holland
    • Capelle Aan Den IJssel, Zuid-Holland, Netherlands, 2906 ZC
      • IJsselland Ziekenhuis
    • Rotterdam, Zuid-Holland, Netherlands, 3045 PM
      • Franciscus Gasthuis
    • Zoetermeer, Zuid-Holland, Netherlands, 2725 NA
      • Reinier Haga Orthopedisch Centrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Orthosis group	Other: Orthosis; 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.
Experimental: Orthosis + exercise group	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life	EuroQol-5-Dimension-5-levels	Time points: baseline, 6 weeks, 3 months, 6 months, 1 year.
Hand Function	Michigan Hand Outcomes Questionnaire	Time points: baseline, 6 weeks, 3 months, 6 months, 1 year.
Satisfaction with treatment results	Satisfaction with Treatment Result Questionnaire	Time points: 6 weeks, 3 months, 6 months, 1 year.
Return to work	Return to work	Time points: 6 weeks, 3 months, 6 months, 9 months, 1 year.
Grip & Pinch strength	Hand-held dynamometer and Pinch	Time points: baseline, 6 weeks, 3 months, 6 months, 1 year.
Range of motion	Goniometry and Kapandji Score	Time points: baseline, 6 weeks, 3 months, 6 months, 1 year.
Experience with healthcare delivery	Patient Reported Experience Measure	Time points: 6 weeks, 3 months.
Complications	ICHOM Modified Clavien-Dindo Classification	Time points: baseline, 6 weeks, 3 months, 6 months, 1 year.
Costs and productivity loss	Productivity Cost Questionnaire, Medical Consumption Questionnaire	Time points: 6 weeks, 3 months, 6 months, 9 months, 1 year.
Treatment adherence	Therapy Adherence Assessment Tool	Time points: 6 wks, 3 months
Treatment credibility and expectations	Credibility/Expectancy Questionnare	Time points: baseline, 6 weeks.
Perceived attention/quality of the relationship	Consultation and Relational Empathy Measure	Time points: 6 weeks, 3 months.
Depression	Patient Health Questionnaire-9	Time points: baseline,3 months.
Anxiety	General Anxiety Disorder-7	Time points: baseline, 3 months.
Illness perception	Brief Illness Perception Questionnaire	Time points: baseline, 3 months.
Pain catastrophizing	Pain Catasctriphizing Scale	Time points: baseline.

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Reinier Haga Orthopedisch Centrum; ZonMw: The Netherlands Organisation for Health Research and Development; Franciscus Gasthuis; Elisabeth-TweeSteden Ziekenhuis; Xpert Clinics; IJsselland ziekenhuis
• Investigators: Principal Investigator: Ruud W Selles, PhD, Erasmus Medical Center

Publications and helpful links

Helpful Links

• Overal study information

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: exercise; orthosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: 852002001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will manage the data following FAIR principles and store the data in DANS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No