No registrations found.
ID
Source
Brief title
Health condition
Thumb carpometacarpal osteoarthritis (CMC-1) / CMC-1 artrose
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.
Sponsors and support
University Medical Center Groningen.
University Medical Center Groningen.
Intervention
Outcome measures
Primary outcome
Pain, measured on a 100 mm visual analogue scale (VAS).
Secondary outcome
1. Hand function, measured with a questionnaire and a hand function test;
2. Compliance, measured with questionnaires and an interview.
Background summary
Rationale:
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.
Objectives:
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.
Study population:
Patients with osteoarthritis of the CMC 1-joint.
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.
Main study parameters/endpoints:
1. Primary parameter: pain, measured on a 100 mm visual analogue scale (VAS);
2. Secondary parameters: handfunction, compliance.
Study objective
There are many orthoses available to treat the symptoms caused by thumb carpometacarpal osteoarthritis. 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.
We will perform a prospective cross-over randomised controlled trial to:
1. 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. Measure compliance and factors influencing compliance with splint therapy for carpometacarpal osteoarthritis.
Study design
T=0: Questionnaires, baseline tests: Jebsen, nine-hole-peg test, pinch grip and key grip;
T= week 1+2: Test orthosis 1: daily diary; end week 2: questionnaire, Jebsen, nine-hole-peg test, pinch grip and key grip;
T= week 3+4: Wash out periode: daily diary; end week 4: questionnaire, Jebsen, nine-hole-peg test, pinch grip and key grip;
T= week 5+6: Test orthosis 2: daily diary; end week 6: questionnaire, Jebsen, nine-hole-peg test, pinch grip and key grip, semi-structured interview.
Intervention
In this prospective cross-over randomised controlled trial patients will use 2 types of orthoses: the off-the-shelf orthosis (Push-brace) and a custom-made orthosis.
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. The order in which the orthoses will be provided will be randomised.
University Medical Center Groningen<br>
Hanzeplein 1
A.E. Vegt, van der
Groningen 9700 RB
The Netherlands
+31 (0)50 3613651
a.e.van.der.vegt@umcg.nl
University Medical Center Groningen<br>
Hanzeplein 1
A.E. Vegt, van der
Groningen 9700 RB
The Netherlands
+31 (0)50 3613651
a.e.van.der.vegt@umcg.nl
Inclusion criteria
1. Primary CMC-1 osteoarthritis, not caused by trauma or other diseases, proven by X-ray which explains patient complaints;
2. Age ≥ 18 years.
Exclusion criteria
1. Secondary CMC-1 osteoarthritis;
2. Previous hand surgery for CMC-1 osteoarthritis;
3. Corticosteroid injection in the last 6 months;
4. Other hand specific diseases like rheumatoid arthritis, carpal tunnel syndrome, radiocarpal osteoarthritis that interfere with study results;
5. Primary arthritis of the scaphoid-trapezium-trapezoideum (STT) joint. In case of a combined arthritis of CMC-1 and STT patients will be included, unless arthritis of STT is more prominent;
6. Insufficient command of the Dutch language;
7. Serious cognitive disorders that will inhibit the patient in expressing the VAS scores and answering the questionnaires.
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 | NL3812 |
| NTR-old | NTR3978 |
| Other | METC UMC Groningen : 2013.55 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |