No registrations found.
ID
Source
Health condition
Thumb base osteoarthritis, CMC-1 OA, duimbasis artrose, basal joint arthritis
Sponsors and support
- Handtherapie Nederland B.V.
- Xpert Clinic Nederland
Intervention
Outcome measures
Primary outcome
- Pain intensity
- Limitations in activities of daily life
- Pinch & grip strength
Secondary outcome
- Return to work
- Patient satisfaction
- Secondary treatment
Background summary
SUMMARY
Background: Osteoarthritis (OA) of the thumb base joint (CMC-1) is a common disorder. More insight in the effect of conservative interventions is needed due to a lack of studies of high methodological quality.
Research Questions: Primary research question (I): what is the effect of a combination of exercise therapy and splinting compared to splinting alone on pain intensity, limitations in activities of daily life (ADL) and pinch & grip strength in patients with CMC-1 OA? Secondary research questions: (II) What is the effect of a combination of exercise therapy and splinting compared to splinting alone on return to work and patient satisfaction in patients with CMC-1 OA? (III) Which baseline determinants can predict outcome on pain intensity, limitations in ADL and pinch & grip strength in patients with CMC-1 OA?
Design: Prospective open cohort with propensity score matching (PSM). Exercise therapy combined with splinting will be compared with splinting alone. Data collection will be part of usual care.
Population: All patients with CMC-1 OA referred by hand surgeons of Xpert Clinic for hand therapy, in a total of ten clinics in the Netherlands.
Parameters and data collection: Primary outcomes include pain intensity (visual analogue scale), limitations in activities of daily life (Michigan Hand Outcomes Questionnaire) and pinch & grip strength (Biometrics E-link ©). Secondary outcomes include return to work and patient satisfaction.
Analyses: After PSM, linear mixed models regression analyses will be conducted with respect to the primary research question (I) and secondary research question (II). Furthermore, independent samples t-tests and the Mann-Whitney test will be used for the secondary research question (I). Multiple imputation will be used in the case of missing data.
Key words: Thumb, carpometacarpal joint, osteoarthritis, exercise therapy, propensity score
Study objective
The hypothesis is that a combination of exercise therapy and splinting is superior to splinting alone in the treatment of patients with thumb base osteoarthritis.
Study design
Baseline
6 weeks
3 months
12 months
Intervention
Exercise therapy and splinting is compared with splinting alone
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Male/female and diagnosed with CMC-1 OA by the hand surgeon. The hand surgeon
follows the guideline of the Dutch Society for Hand Surgery in the diagnostic
process.15
- Eaton-Glickel20 stage I-IV
- Age ≥18
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Secondary basal joint arthritis (i.e. due to Bennet fracture)
- Comorbidities that may interfere with treatment/ bias outcome (i.e. rheumatoid arthritis,
carpal tunnel syndrome, Quervain tenosynovitis)
- Patient history includes surgery that may interfere with treatment/ bias outcome
- Steroid injection <6 weeks in hand or wrist
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5362 |
| NTR-old | NTR5627 |
| Other | : MEC-2015-691 |