Overview

Neuroma Injections to Treat Restless Legs Syndrome - RCT

Status:
Unknown status
Trial end date:
2009-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lowcountry Infectious Diseases
Treatments:
Bupivacaine
Ethanol
Lidocaine
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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