Neuroma Injections to Treat Restless Legs Syndrome - RCT

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Lowcountry Infectious Diseases.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lowcountry Infectious Diseases
ClinicalTrials.gov Identifier:
NCT00656110
First received: April 6, 2008
Last updated: March 9, 2009
Last verified: March 2009
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Lowcountry Infectious Diseases:

Primary Outcome Measures:
  • International Restless Legs Rating Scale [ Time Frame: Weekly during the study and three weeks after treatment completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656110

Contacts
Contact: Ludwig A Lettau, MD 843-402-0227 lettaul@comcast.net
Contact: Lisa A Lettau, RN, BSN 843-813-2940 lettaul@comcast.net

Locations
United States, South Carolina
Southeastern Foot Specialists Recruiting
Charleston, South Carolina, United States, 29414
Contact: Charles J Gudas, DPM    843-852-9444    gudasturbo@bellsouth.net   
Sub-Investigator: Charles J Gudas, DPM         
Sponsors and Collaborators
Lowcountry Infectious Diseases
Investigators
Principal Investigator: Ludwig A Lettau, MD Lowcountry Infectious Diseases
  More Information

Publications:
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

Responsible Party: Ludwig A. Lettau, M.D., Lowcountry Infectious Diseases
ClinicalTrials.gov Identifier: NCT00656110     History of Changes
Other Study ID Numbers: LID-RLS-RCT-01, (None)
Study First Received: April 6, 2008
Last Updated: March 9, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Lowcountry Infectious Diseases:
Restless legs syndrome
Morton's neuroma
Randomized controlled trial

Additional relevant MeSH terms:
Restless Legs Syndrome
Psychomotor Agitation
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Ethanol
Lidocaine
Methylprednisolone acetate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 24, 2014