Overview
Neuroma Injections to Treat Restless Legs Syndrome - RCT
Status:
Unknown status
Unknown status
Trial end date:
2009-12-01
2009-12-01
Target enrollment:
0
0
Participant gender:
All
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/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Lowcountry Infectious DiseasesTreatments:
BupivacaineEthanol
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