NCT00284583

Brief Summary

Interdigital neuroma is a painful forefoot disorder characterized by plantar pain and toe paresthesias thought to result from entrapment of the interdigital nerve by the overlying transverse metatarsal ligament. Multiple treatments have been recommended for this condition and range from modification of shoe wear to surgical excision of the painful nerve. Serial ethanol injection therapy has been reported to be an effective alternative to surgical excision. However, despite wide adoption of this treatment, no randomized, double blinded, placebo-controlled study exists to verify the efficacy of this treatment in comparison to longer standing similar therapies, such as corticosteroid injection. 120 patients from one Orthopaedic group's foot and ankle offices with single foot neuromas and no previous history of neuroma or foot disorder treatment will be selected for the study. These patients will be randomized to three treatments, specifically lidocaine injection, corticosteroid injection, or ethanol injection. Outcomes will be assessed at 3, 6 and 12 month time points using validated questionnaires as well as a non-validated disease specific questionnaire. Primary endpoint will be graded change in the physical function portion of the SF-36 form. Secondary endpoints will be the graded change in the McGill Short Form for Pain and ultimate satisfaction with treatment as assessed by a non-validated questionnaire designed for Morton's neuroma symptoms.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2006

Completed
Last Updated

February 1, 2006

Status Verified

January 1, 2006

First QC Date

January 30, 2006

Last Update Submit

January 30, 2006

Conditions

Morton's Neuroma

Keywords

Morton's NeuromaAlcoholSteroid

Outcome Measures

Primary Outcomes (2)

  • 1. Pain Scale

  • 2. Physical function scale.

Interventions

Injection of Steroid into FootDRUG
Injection of Alcohol into FootDRUG
Injection of Lidocaine into FootDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • months of 2 or more of the following
  • Plantar pain increased by walking localized to the 2nd and 3rd interspaces
  • Relief of pain by resting
  • Pain radiating into toes
  • Numbness in toes or foot
  • Cramping in toes and foot
  • or More of the Following physical Findings
  • Plantar tenderness
  • Radiation of elicited pain into the toes
  • Palpable plantar mass
  • Numbness in toes
  • Exacerbation of symptoms with Mulder's maneuver

You may not qualify if:

  • Past treatment for Morton's neuroma or had prior foot surgery.
  • Concurrent conditions such as hallux valgus, metatarsalgia, lesser toe abnormalities, atraumatic synovitis of metatarsophalangeal joint and other foot and ankle based nerve compression neuropathies.
  • Further, patients with neuroma symptoms in the 1st and 4th interspaces.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital Orthopaedic Clinic

Providence, Rhode Island, 02908, United States

RECRUITING

Related Publications (4)

  • Bennett GL, Graham CE, Mauldin DM. Morton's interdigital neuroma: a comprehensive treatment protocol. Foot Ankle Int. 1995 Dec;16(12):760-3. doi: 10.1177/107110079501601204.

    PMID: 8749346BACKGROUND

  • Bradley N, Miller WA, Evans JP. Plantar neuroma: analysis of results following surgical excision in 145 patients. South Med J. 1976 Jul;69(7):853-4.

    PMID: 941051BACKGROUND

  • Dockery GL. The treatment of intermetatarsal neuromas with 4% alcohol sclerosing injections. J Foot Ankle Surg. 1999 Nov-Dec;38(6):403-8. doi: 10.1016/s1067-2516(99)80040-4.

    PMID: 10614611BACKGROUND

  • Fanucci E, Masala S, Fabiano S, Perugia D, Squillaci E, Varrucciu V, Simonetti G. Treatment of intermetatarsal Morton's neuroma with alcohol injection under US guide: 10-month follow-up. Eur Radiol. 2004 Mar;14(3):514-8. doi: 10.1007/s00330-003-2057-7. Epub 2003 Oct 3.

    PMID: 14531002BACKGROUND

MeSH Terms

Conditions

Morton Neuroma

Interventions

Ethanol

Condition Hierarchy (Ancestors)

MetatarsalgiaFoot DiseasesMusculoskeletal DiseasesJoint DiseasesNeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Christopher Digiovanni, MD

    Rhode Island Hospital, Brown Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark C Lee, MD

CONTACT

401-350-6432marklee007@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 30, 2006

First Posted

February 1, 2006

Study Start

May 1, 2005

Last Updated

February 1, 2006

Record last verified: 2006-01

Locations

US(1)