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Neuroma Injections to Treat Restless Legs Syndrome - RCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00656110
Recruitment Status : Unknown
Verified March 2009 by Lowcountry Infectious Diseases.
Recruitment status was:  Recruiting
First Posted : April 10, 2008
Last Update Posted : March 10, 2009
Information provided by:
Lowcountry Infectious Diseases

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.

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: 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 Drug: Normal saline - 1ml Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Placebo-Controlled Trial of Bilateral 3rd/4th Common Digital Foot Nerve Injections to Treat Restless Legs Syndrome
Study Start Date : April 2008
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1-T
Treatment Group
Drug: 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

Placebo Comparator: 2-P
Placebo comparator
Drug: Normal saline - 1ml
Bilateral 3rd/4th common digital nerve injections with normal saline given weekly for 3 weeks

Primary Outcome Measures :
  1. International Restless Legs Rating Scale [ Time Frame: Weekly during the study and three weeks after treatment completion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00656110

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Contact: Ludwig A Lettau, MD 843-402-0227
Contact: Lisa A Lettau, RN, BSN 843-813-2940

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United States, South Carolina
Southeastern Foot Specialists Recruiting
Charleston, South Carolina, United States, 29414
Contact: Charles J Gudas, DPM    843-852-9444   
Sub-Investigator: Charles J Gudas, DPM         
Sponsors and Collaborators
Lowcountry Infectious Diseases
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Principal Investigator: Ludwig A Lettau, MD Lowcountry Infectious Diseases
Lettau LA, Gudas CJ. Bilateral Morton's neuromas as an etiology of restless legs syndrome. Journal of the South Carolina Medical Association 101: e341-e347, 2005

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Responsible Party: Ludwig A. Lettau, M.D., Lowcountry Infectious Diseases Identifier: NCT00656110    
Other Study ID Numbers: LID-RLS-RCT-01
First Posted: April 10, 2008    Key Record Dates
Last Update Posted: March 10, 2009
Last Verified: March 2009
Keywords provided by Lowcountry Infectious Diseases:
Restless legs syndrome
Morton's neuroma
Randomized controlled trial
Additional relevant MeSH terms:
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Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents