About this trial
Morton's neuroma is a benign thickening involving the plantar interdigital nerve, most common in middle aged women. Morton's neuroma is one of the most frequent diagnoses seen in the investigators podiatry clinic and is difficult to treat. These lesions cause a burning or shooting pain that can radiate to the toes, or an aching pain in the ball of the foot. The pain is exacerbated with activity and certain footwear greatly limits activity in the involved patient population. Morton's neuroma is first treated conservatively with orthotics. Patients may require further interventions such as steroid injections. The literature reports only a 30% long term resolution of pain with the steroid. Surgical resection has a reported 51-85% success rate with 14-21% rate of complication; recurrent pain, numbness/loss of sensation, and subsequent stump neuromas.
Cryoablation is well known to be efficacious for neuropathic pain and has recently been shown in two small studies to be safe and efficacious for treatment of Morton's neuroma. The investigators study will compare outcomes of cryoablation to corticosteroid injection in short- and long-term for treatment of Morton's neuroma that have failed conservative therapy.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age >18 years
Able to consent and complete questionnaires
Failure of a four-week trial of conservative therapy (includes orthotics, appropriate footwear, and/or metatarsal pads)
X-ray and ultrasound excluding other pathology and confirming the presence and location of a Morton's neuroma
Disqualifiers
Inability to follow-up or to comply with the follow-up protocol
Contraindication to cryoablation and/or lidocaine/steroid injection
Other pathology which could account for symptoms identified on imaging studies
Unwillingness to be randomized
Trial design
Parallel
Treatments tested in this trial
Cryoablation
DeviceImage (ultrasound and fluoroscopic guided) cryoablation will be performed of the Morton's neuroma after nerve block.
Nerve block
Procedure/SurgeryUltrasound and fluoroscopic guided nerve block.
Treatment groups
Trial outcomes
Primary outcomes
Changes in quality of life
Will be evaluated using the SF-36 Quality of Life Survey
Réponse in pain
Will be evaluated using the visual analog scale with 0 as no pain and 10 as the word pain imaginable
Changes to function
Changes to the modified American Orthopedic Foot and Ankle Society Hallux Metatarsophalangeal--Interphalangeal Scale, higher score is less symptomatic
Changes pain and function due to neuroma
Changes in Neuroma Scale, higher score is less symptomatic
Sponsors and contacts
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Oregon Health and Science University
Lead sponsor
Boston Scientific Corporation
Collaborator
Society of Interventional Radiology Foundation
Collaborator