Neuroma Injections to Treat Restless Legs Syndrome - RCT

Status unconfirmed · Not applicable

Conditions studied: Restless Legs Syndrome

In brief

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.

Key facts

Study ID

NCT00656110

Run by

Lowcountry Infectious Diseases

People needed

60

Starts

2008-04-01

Expected to finish

2009-12-01

Last updated by the study team

2009-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical symptoms (that fulfill the 4 essential clinical criteria for RLS) of at least 6 months duration with a current IRLS-rs score indicative of at least moderate severity (15 or greater)
• Evidence of bilateral 3rd/4th interspace neuromas by both physical examination and ultrasound criteria at initial evaluation
• Willingness and ability of patient to participate in initial weekly evaluation/neuroma treatment visits and subsequent periodic follow-up visits over a period of approximately 6-9 weeks.
• Off dopaminergic drug treatment (ropinirole-"Requip" or pramipexole-"Mirapex") starting 2 weeks prior to the initial foot injections and for the duration of the study.

You may not qualify if…

• Major foot deformity, previous major foot surgery, or previous neuroma injections
• Known or suspected obstructive sleep apnea
• Allergy to any of injection components (depo-medrol, lidocaine, marcaine, absolute alcohol)
• Pregnancy

Where it is running

• Southeastern Foot Specialists — Charleston, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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