Neuroma Injections to Treat Restless Legs Syndrome - RCT - Full Text View

Sponsored by:	Lowcountry Infectious Diseases
Information provided by:	Lowcountry Infectious Diseases
ClinicalTrials.gov Identifier:	NCT00656110

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

MedlinePlus related topics: Foot Health Restless Legs

Drug Information available for: Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Lidocaine Ethanol Bupivacaine Bupivacaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized, Placebo-Controlled Trial of Bilateral 3rd/4th Common Digital Foot Nerve Injections to Treat Restless Legs Syndrome

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 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1-T: Experimental 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
2-P: Placebo Comparator 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

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

Keywords provided by Lowcountry Infectious Diseases:

Restless legs syndrome
Morton's neuroma
Randomized controlled trial

Study placed in the following topic categories:

Ekbom syndrome
Methylprednisolone
Lidocaine
Methylprednisolone acetate
Sleep Disorders
Dyssomnias
Prednisolone acetate
Psychomotor Agitation
Dyskinesias
Sleep Disorders, Intrinsic

Signs and Symptoms
Mental Disorders
Prednisolone
Restless Legs Syndrome
Neurologic Manifestations
Bupivacaine
Neuroma
Neurobehavioral Manifestations
Methylprednisolone Hemisuccinate
Ethanol

Additional relevant MeSH terms:

Anti-Infective Agents
Disease
Nervous System Diseases
Parasomnias
Physiological Effects of Drugs
Central Nervous System Depressants
Pharmacologic Actions

Anti-Infective Agents, Local
Pathologic Processes
Syndrome
Therapeutic Uses
Psychomotor Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009