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The effect of exercise therapy in patients with thumb base osteoarthritis


- candidate number23521
- NTR NumberNTR5627
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-dec-2015
- Secondary IDsMEC-2015-691 
- Public TitleThe effect of exercise therapy in patients with thumb base osteoarthritis
- Scientific TitleThe effect of Hand Therapy in patients with thumb base osteoarthritis: a prospective cohort study with propensity score matching
- ACRONYM
- hypothesisThe hypothesis is that a combination of exercise therapy and splinting is superior to splinting alone in the treatment of patients with thumb base osteoarthritis.
- Healt Condition(s) or Problem(s) studiedThumb carpometacarpal osteoarthritis (CMC-1)
- Inclusion criteriaIn 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 criteriaA 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 12-okt-2015
- planned closingdate1-mei-2017
- Target number of participants148
- InterventionsExercise therapy and splinting is compared with splinting alone
- Primary outcome- Pain intensity
- Limitations in activities of daily life
- Pinch & grip strength
- Secondary outcome- Return to work
- Patient satisfaction
- Secondary treatment
- TimepointsBaseline
6 weeks
3 months
12 months
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Robbert Wouters
- CONTACT for SCIENTIFIC QUERIESDr. Ruud W. Selles
- Sponsor/Initiator Erasmus Medical Center, Handtherapie Nederland B.V., Xpert Clinic Nederland
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summarySUMMARY 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
- Main changes (audit trail)
- RECORD22-dec-2015 - 27-feb-2016


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