Splinting for carpometacarpal osteoarthritis.

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.

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.

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.

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.