Recruiting

Neuroma Injections

Sponsor:

Lowcountry Infectious Diseases

Code:

NCT00656110

Conditions

Restless Legs Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Normal saline - 1ml

Study Details

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.

Conditions

Restless Legs Syndrome

Study ID

NCT00656110

Start date

Apr, 2008

Status verified date

Mar, 2009

Completion date

Dec, 2009

Anticipated

Primary completion date

Nov, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1-T

Treatment Group

placebo comparator: 2-P

Placebo comparator

Interventions

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

Normal saline - 1ml

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

Primary outcome measure

  • International Restless Legs Rating Scale [ Time Frame: Weekly during the study and three weeks after treatment completion ]

Central Contacts and Locations

Central contacts

Ludwig A Lettau, MD

843-402-0227lettaul@comcast.net

Lisa A Lettau, RN, BSN

843-813-2940lettaul@comcast.net

Locations

Southeastern Foot Specialists

Recruiting

Charleston, South Carolina, United States, 29414

Contacts

Charles J Gudas, DPM

843-852-9444gudasturbo@bellsouth.net

More Information

Sponsor

Lowcountry Infectious Diseases

Last update posted

Mar 10, 2009

Last verified

Mar, 2009

Keywords

  • Restless legs syndrome
  • Morton's neuroma
  • Randomized controlled trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lowcountry Infectious Diseases on 2009-03-10.