NCT00656110

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 10, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 10, 2009

Status Verified

March 1, 2009

Enrollment Period

1.6 years

First QC Date

April 6, 2008

Last Update Submit

March 9, 2009

Conditions

Restless Legs Syndrome

Keywords

Restless legs syndromeMorton's neuromaRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • International Restless Legs Rating Scale

    Weekly during the study and three weeks after treatment completion

Study Arms (2)

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

2-P

PLACEBO COMPARATOR

Placebo comparator

Drug: Normal saline - 1ml

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 mlDRUG

Bilateral 3rd/4th common digital nerve injections with neuroma treatment mixture given weekly for 3 weeks

1-T
Normal saline - 1mlDRUG

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

2-P

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southeastern Foot Specialists

Charleston, South Carolina, 29414, United States

RECRUITING

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Restless Legs SyndromeMorton Neuroma

Interventions

EthanolSaline Solution

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental DisordersMetatarsalgiaFoot DiseasesMusculoskeletal DiseasesJoint DiseasesNeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Ludwig A Lettau, MD

    Lowcountry Infectious Diseases

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ludwig A Lettau, MD

CONTACT

843-402-0227lettaul@comcast.net

Lisa A Lettau, RN, BSN

CONTACT

843-813-2940lettaul@comcast.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 6, 2008

First Posted

April 10, 2008

Study Start

April 1, 2008

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

March 10, 2009

Record last verified: 2009-03

Locations

US(1)