Comparison of Alcohol and Steroid Injection for Treating Morton's Neuroma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brown University
• Treatments: Ethanol; Lidocaine

Criteria

Inclusion Criteria:

2 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

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:

• 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.