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Neuroma Injections to Treat Restless Legs Syndrome - RCT

NCT00656110 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2009-03-10

No results posted yet for this study

Summary

The purpose of this study is to determine whether, in a randomized, placebo-controlled trial, restless legs syndrome (RLS) can be caused by pinched and damaged foot nerves called neuromas.

Conditions

  • Restless Legs Syndrome

Interventions

DRUG

equal parts of 0.5% plain Marcaine and 2% lidocaine mixed with 0.8 mg Depo-medrol/4% absolute alcohol in a total injection volume of 1 ml

Bilateral 3rd/4th common digital nerve injections with neuroma treatment mixture given weekly for 3 weeks

DRUG

Normal saline - 1ml

Bilateral 3rd/4th common digital nerve injections with normal saline given weekly for 3 weeks

Sponsors & Collaborators

  • Lowcountry Infectious Diseases

    lead OTHER

Principal Investigators

  • Ludwig A Lettau, MD · Lowcountry Infectious Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-11-30
Completion
2009-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00656110 on ClinicalTrials.gov