search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Splinting for carpometacarpal osteoarthritis.


- candidate number14833
- NTR NumberNTR3978
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-mei-2013
- Secondary IDs2013.55 METC UMC Groningen
- Public TitleSplinting for carpometacarpal osteoarthritis.
- Scientific TitleSplinting for carpometacarpal osteoarthritis: Which splint reduces pain the most?
- ACRONYMSplinting for carpometacarpal osteoarthritis.
- hypothesisThere 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.
- Healt Condition(s) or Problem(s) studiedThumb carpometacarpal osteoarthritis (CMC-1)
- Inclusion criteria1. Primary CMC-1 osteoarthritis, not caused by trauma or other diseases, proven by X-ray which explains patient complaints;
2. Age ≥ 18 years.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2013
- planned closingdate1-mei-2015
- Target number of participants80
- InterventionsIn 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.
- Primary outcomePain, measured on a 100 mm visual analogue scale (VAS).
- Secondary outcome1. Hand function, measured with a questionnaire and a hand function test;
2. Compliance, measured with questionnaires and an interview.
- TimepointsT=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.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc. A.E. Vegt, van der
- CONTACT for SCIENTIFIC QUERIESMSc. A.E. Vegt, van der
- Sponsor/Initiator University Medical Center Groningen (UMCG), Department of Rehabilitation Medicine
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG), Department of Rehabilitation Medicine
- PublicationsN/A
- Brief summaryRationale:
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.
- Main changes (audit trail)
- RECORD1-mei-2013 - 23-mei-2013


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl