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

NCT ID: NCT05501262

Condition: Morton Neuroma

Conditions: Official terms:
Neuroma
Morton Neuroma

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Participant)

Intervention:

Intervention type: Device
Intervention name: Cryoablation
Description: Image (ultrasound and fluoroscopic guided) cryoablation will be performed of the Morton's neuroma after nerve block.
Arm group label: Study

Intervention type: Procedure
Intervention name: Nerve block
Description: Ultrasound and fluoroscopic guided nerve block.
Arm group label: Standard of Care

Summary: 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 105 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Oregon Health Sciences University

Address:
City: Portland
Zip: 97239
Country: United States

Status: Recruiting

Contact:
Last name: Lori Russell

Start date: July 25, 2022

Completion date: December 31, 2023

Lead sponsor:
Agency: Oregon Health and Science University
Agency class: Other

Source: Oregon Health and Science University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05501262

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