The THumb Osteoarthritis Exercise TriAl

Thumb Osteoarthritis Clinical Trial

— THETA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05772715
• Other study ID #: 852002001
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: February 15, 2024

Study information

• Verified date: February 2024
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Osteoarthritis
• Thumb Osteoarthritis

Intervention

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).
• 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.

Locations

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

Sponsors (7)

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

Country where clinical trial is conducted

Netherlands, 

Outcome

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.

External Links

•   Overal study information