Comparative Effectiveness of Cryoablation Using the ICE-Seed Cryoablation Needle With Steroid and Lidocaine Versus Steroid and Lidocaine Alone for Treatment of Morton's Neuroma

Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 105
Healthy Volunteers: t
View:

• 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

Locations
United States
Oregon
Oregon Health Sciences University
RECRUITING
Portland
Contact Information
Primary
Lori L Russell, MSN BSN RN
watsonlo@ohsu.edu
503-494-7226
Time Frame
Start Date: 2022-07-25
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 32
Treatments
Active_comparator: Standard of Care
Steroid and lidocaine injection
Experimental: Study
Steroid and lidocaine injection with cryoablation
Related Therapeutic Areas
Sponsors
Collaborators: Boston Scientific Corporation, Society of Interventional Radiology Foundation
Leads: Oregon Health and Science University

This content was sourced from clinicaltrials.gov