drugset / Trial / NCT02652390

Local Steroid Injection vs Placebo in Carpal Tunnel Syndrome

NCT02652390

Phase 4 Completed 111 enrolled Region Skane
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Between 2008 and 2012 the investigators performed a single-center randomized double-blind placebo-controlled trial to assess the efficacy of local injection of two different doses of methylprednisolone (80 mg and 40 mg) in patients with carpal tunnel syndrome (CTS), aged 18 to 70 years, not previously treated with steroid injection. The primary outcomes were change in the CTS symptom severity score at 10 weeks and rate of carpal tunnel release surgery on the study hand at 1 year. In the trial 111 patients were randomized (37 in each of the 3 groups: 80 mg methylprednisolone, 40 mg methylprednisolone and placebo) and all completed the 1-year follow-up. The investiators plan an extended follow-up 5 to 7 years after injection.

Timeline

Start
2016-02
Primary completion
2016-10
Completion
2016-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylprednisolone Other / unclassified 40 mg Other
Subject Methylprednisolone Other / unclassified 80 mg Other