Rationale

Carpal tunnel syndrome (CTS) is the most common peripheral neuropathy. The optimal treatment strategy is still unknown. This results in considerable practice variation in the treatment of CTS.

 

Objective

the objective is to investigate if initial surgical treatment of CTS results in a better outcome and is more cost-effective when compared to initial treatment with a steroid injection.

 

Study design

multicenter open-label randomized controlled trial.

 

Study population

Adult patients with CTS.

 

Intervention

One strategy starts with surgical treatment and the other strategy starts with a steroid injection. The choice for possible subsequent treatments is at the patient and physician’s discretion.

Main study parameters/endpoints: the primary objective is to assess if the treatment strategy starting with a surgical treatment results in a higher rate of recovery compared to starting treatment with a steroid injection. Recovery is defined as having no or mild CTS symptoms as measured with the 6-item carpal tunnel symptoms scale. Follow-up is 18 months. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: surgical treatment and steroid injections for CTS have been widely used treatments and patients will not be exposed to additional risks. The patient has to fill in eight self-report questionnaires in the course of 18 months. We estimate that this may take 4 hours (4x 0,7hrs + 4x 0,3hrs).