CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 112 enrolled
Drug / intervention
Methylprednisolone 40 mg +2 moredrug
Likely dose
Methylprednisolone 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00806871
NCT00806871Phase 3Completed

Local Steroid Injection in the Treatment of Idiopathic Carpal Tunnel Syndrome: A Randomized Double-blind Placebo-controlled Trial Among Patients Planned for Surgical Treatment

Region Skane·interventional·Posted Dec 11, 2008·Updated Apr 4, 2012

In Brief

A Phase 3 clinical trial evaluating Methylprednisolone 40 mg, Methylprednisolone 80 mg, and 1 other intervention for Carpal Tunnel Syndrome. Completed, enrolled 112 participants across 1 site.

Detailed Summary

The aim of this study is to assess the efficacy of injecting steroid into the carpal tunnel in relieving symptoms of carpal tunnel syndrome for at least 1 year with outcomes measured with patient evaluated symptoms score.Out of the patients referred by primary care, those with a clinical diagnosis of CTS who have tried wrist splint and whose symptom severity is judged by the examining surgeon to warrant surgery are offered to be put on the waiting list for carpal tunnel release. This means a waiting time of approximately 3 months. Patients who give informed consent will be asked to attend the outpatient clinic for a physical examination followed by allocation to one of the three trial groups. Immediately following the allocation the patients will receive the assigned treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 11, 2008
Enrollment StartNov 1, 2008
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 17.6 years ago

Interventions

Methylprednisolone 40 mgdrug

Depo-medrol 40 mg , suspension, injection in the carpal tunnel, one time use 1 ml 40 mg Methylprednisolone + 1 ml 10mg Lidocaine + 1 ml saline

Methylprednisolone 80 mgdrug

Depo-medrol 80 mg , suspension, injection in the carpal tunnel, one time use. 2 ml 80mg Methylprednisolone + 1 ml 10mg Lidocaine

Sodium chloridedrug

Saline solution 0,9%, injection in the carpal tunnel, one time use 1 ml 10 mg Lidocaine + 2 ml saline