At a glance
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Extended Follow-up of a Randomized Placebo-controlled Trial of Local Steroid Injection in Carpal Tunnel Syndrome
In Brief
A Phase 4 clinical trial evaluating Methylprednisolone 80 mg, Methylprednisolone 40 mg, and 1 other intervention for Carpal Tunnel Syndrome. Completed, enrolled 111 participants.
Detailed 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.
Study Details
Timeline
Interventions
2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine
1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine
2 mL saline + 1 mL lidocaine