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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27581
Enrollment
512
Registered
2020-02-26
Start date
2019-12-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thumb base osteoarthritis

Interventions

Sponsors

ZonMW
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All participants must meet the following criteria: 1) age = 18 years; 2) Eaton(35) stage 2-3 CMC-1 OA based on radiographics & clinical examination; and 3) ability to visit the treatment center for treatment sessions.

Exclusion criteria

Exclusion criteria: A potential participant that meets any of the following criteria will be excluded: 1) secondary 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.

Design outcomes

Primary

MeasureTime frame
Pain (3mo) and conversion to surgery (12 mo)

Secondary

MeasureTime frame
- Health related quality of life (EQ-5D) - Hand function/ADL (MHQ) - Patient satisfaction with treatment result (ICHOM self-designed) - Return to work (ICHOM self-designed) - Grip & pinch strength (Jamar, key pinch and tip pinch) - Thumb ROM (goniometry and inter metacarpal distance), - Reported experience - Complications (all complications are classified and registered throughout the trial) - Costs & productivity loss (iPCQ) - Treatment adherence (therapy adherence assessment tool) - Treatment credibility and expectations (CEQ) - Perceived attention/quality of the relationship (CARE) - Psychological factors, including anxiety & depression (PHQ), Illness perception (brief-IPQ) and pain catastrophizing (PCS)

Contacts

Public ContactRobbert Wouters

Erasmus MC Rotterdam

r.wouters@erasmusmc.nl(010) 704 0 704

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)