Status:
UNKNOWN
Neuroma Injections to Treat Restless Legs Syndrome - RCT
Lead Sponsor:
Lowcountry Infectious Diseases
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
Restless legs syndrome (RLS) is a medical condition in which there is an almost irresistible urge to move the legs in response to uncomfortable, difficult-to-describe leg sensations that are usually w...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00656110
Start Date
April 1 2008
End Date
December 1 2009
Last Update
March 10 2009
Active Locations (1)
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1
Southeastern Foot Specialists
Charleston, South Carolina, United States, 29414