(1) To analyze differences in pain and function in patients with CMC-1 osteoarthritis after application of a custom made orthosis and an off-the-shelf orthosis (Push brace) (2) To measure compliance and factors influencing compliance with splint…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain, measured on a 100 mm visual analogue scale (VAS).
Secondary outcome
Handfunction and compliance.
Background summary
Thumb carpometacarpal osteoarthritis (CMC-1) is a common disease, especially in
the female population aged 40 and up. The main complaint is pain during use of
the thumb and loss of function due to pain. There are many orthoses available
to treat these symptoms, it is however not known which type reduces pain the
most, which orthosis is preferred by patients and which factors influence
compliance with splint therapy.
Study objective
(1) To analyze differences in pain and function in patients with CMC-1
osteoarthritis after application of a custom made orthosis and an off-the-shelf
orthosis (Push brace)
(2) To measure compliance and factors influencing compliance with splint
therapy for carpometacarpal osteoarthritis.
Study design
Prospective cross-over randomised controlled trial.
Intervention
Patients will first receive one orthosis, to be used for two weeks. After a 2
week washout period they will be given a second orthosis for another two weeks.
Measurements will take place before and after each test period. The order in
which the orthoses will be provided will be randomised.
Study burden and risks
There will be four visits to our centres during this study instead of two to
three visits that would occur in daily practice. During visits the orthosis
will be custom made, the off-the-shelf brace will be fitted and tests will be
performed. Besides, patients will be asked to fill out 4 questionnaires and to
keep a diary daily. There will be no invasive tests or other treatments. Both
orthoses are safe to use and will not harm patients.
At the beginning of the study a recent X-ray (<1 year old) has to be available
of every patient for classification of the osteoarthritis. This corresponds to
standard care for patients visiting the outpatient clinic. Therefore we do not
see this as an extra incriminating research for the patients included in the
study.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
- Primary CMC-1 osteoarthritis, proven by X-ray, which explains patient complaints.
- Age >= 18 years.
Exclusion criteria
- Secondary CMC-1 osteoarthritis.
- Previous hand surgery for CMC-1 osteoarthritis.
- Corticosteroid injection in the last 6 months.
- Other hand specific diseases like rheumatoid arthritis, carpal tunnel syndrome, radiocarpal osteoarthritis that interfere with study results.
- Primary arthritis of the STT joint. In case of a combined arthritis of CMC-1 and STT patients will be included, unless arthritis of STT is more prominent.
- Insufficient command of the Dutch language.
- Serious cognitive disorders that will inhibit the patient in expressing the VAS scores and answering the questionnaires.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL42987.042.13 |