NCT00284583|Unknown
Comparison of Alcohol and Steroid Injection for Treating Morton's Neuroma
Comparison of Corticosteroid and Ethanol Injection Therapy in the Treatment of Morton's Neuroma
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Comparison of Corticosteroid and Ethanol Injection Therapy in the Treatment of Morton's Neuroma
Sponsor study identifier
interventional
120
1 country
1
Study Start
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedInterdigital 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
January 30, 2006
Actual (reported)February 1, 2006
Actual (reported)1. Pain Scale
2. Physical function scale.
Rhode Island Hospital Orthopaedic Clinic
Providence, Rhode Island, 02908, United States
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.
Christopher Digiovanni, MD
Rhode Island Hospital, Brown Medical School
First Submitted
January 30, 2006
First Posted
February 1, 2006
Study Start
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
February 1, 2006
Record last verified: 2006-01
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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.