Comparison of Alcohol and Steroid Injection for Treating Morton's Neuroma
NCT ID: NCT00284583
Last Updated: 2006-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2005-05-31
Brief Summary
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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.
Detailed Description
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Current understanding of interdigital neuroma is based on Gauthier's conclusion in 1979 that the symptom complex was a result of an entrapment neuropathy of the interdigital nerve by the overlying transverse metatarsal ligament. Presently, no definitive single etiology has been confirmed. Additional potential pathoetiologies include the aberrant anatomy of the plantar nerve in this location, trauma and extrinsic mass effect above or below the level of the transverse metatarsal ligament.(3,6) The histological appearance of the affected nerve, however, is consistent and suggests that "neuroma" is a misnomer for this condition. The nerve tissue demonstrates demyelination and deposition of amorphous eosinophilic material, but no exuberant proliferation of nerve endings characteristic of neuroma.(3)
Multiple treatments have been recommended for the management of interdigital neuroma. The usual algorithm begins with an attempt at conservative therapy consisting of shoe wear modifications and the application of a metatarsal pad. Failure of conservative management may prompt a trial of corticosteroid injections.(8) Persistent symptoms ultimately require surgical excision or division of the transverse metatarsal ligament, both of which have good long term outcomes in literature.(2,7)
Recently, serial ethanol injection therapy has been reported to be an effective alternative to surgical excision and has been widely adopted in the treatment of Morton's neuroma. Dockery et. al. reported 89% success rate in a series of 100 consecutive patients treated with 3 to 7 injections of 4% ethanol solutions with an average follow-up of 13 months. Fanucci and Masala reported a 90% success rate at 10 month follow-up after 3 to 7 injections of 30% alcohol in a consecutive series of 40 patients. However, none of these studies were performed in a randomized, double blinded fashion with adequate controls. Therefore, no scientifically valid conclusions concerning treatment efficacy can be made.
The proposed study investigates alcohol sclerosing therapy for the treatment of Morton's neuroma in a randomized, double-blinded, placebo-controlled clinical trial. The primary end point will be evaluation of patient physical function according to the standardized SF-36 questionnaire after the treatment period. Secondary end points include evaluation of pain and satisfaction levels after treatment using, respectively, a standardized and a novel questionnaire.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Injection of Steroid into Foot
Injection of Alcohol into Foot
Injection of Lidocaine into Foot
Eligibility Criteria
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Inclusion Criteria
* 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
2 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
Exclusion Criteria
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
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Brown University
OTHER
Principal Investigators
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Christopher Digiovanni, MD
Role: PRINCIPAL_INVESTIGATOR
Rhode Island Hospital, Brown Medical School
Locations
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Rhode Island Hospital Orthopaedic Clinic
Providence, Rhode Island, United States
Countries
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Central Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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0061-05
Identifier Type: -
Identifier Source: org_study_id