Comparative Effectiveness of Cryoablation Versus Steroid and Lidocaine Alone for Treatment of Morton's Neuroma

Oregon Health & Science University (OHSU)

Status: Enrolling

Conditions: Morton Neuroma

Treatments: Procedure: Nerve block; Device: Cryoablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05501262

STUDY00024090

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 105 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

Steroid and lidocaine injection

Treatment:

Procedure: Nerve block

Study

Experimental group

Description:

Steroid and lidocaine injection with cryoablation

Treatment:

Device: Cryoablation