Morton's Neuroma Clinical Trial
Official title:
Comparison of Corticosteroid and Ethanol Injection Therapy in the Treatment of Morton's Neuroma
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.
Interdigital neuroma, or Morton’s Neuroma, is a painful forefoot disorder characterized by
plantar pain and paresthesias radiating to toes. The condition was first described in 1845
by Lewis Durlacher as a painful “neuralgic affection” of the plantar nerve between the third
and fourth metatarsals. T.G. Morton, in 1876, attributed the painful symptom complex to a
“neuroma.” His observation was confirmed by Hoadley who, in 1893, performed a curative
excision of a "neuroma" between the third and fourth metatarsals.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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