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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Morton Neuroma
• Intervention / Treatment: Procedure: Nerve block; Device: Cryoablation

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lori L Russell, MSN BSN RN; Phone Number: 503-494-7226; Email: watsonlo@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health Sciences University
      • Contact: Lori Russell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 101 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; Steroid and lidocaine injection	Procedure: Nerve block; Ultrasound and fluoroscopic guided nerve block.
Experimental: Study; Steroid and lidocaine injection with cryoablation	Device: Cryoablation; Image (ultrasound and fluoroscopic guided) cryoablation will be performed of the Morton's neuroma after nerve block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in quality of life	Will be evaluated using the SF-36 Quality of Life Survey	1 year post procedure
Réponse in pain	Will be evaluated using the visual analog scale with 0 as no pain and 10 as the word pain imaginable	1 year post procedure
Changes to function	Changes to the modified American Orthopedic Foot and Ankle Society Hallux Metatarsophalangeal--Interphalangeal Scale, higher score is less symptomatic	1 year post procedure
Changes pain and function due to neuroma	Changes in Neuroma Scale, higher score is less symptomatic	1 year post procedure
Incidence of Treatment - Emergent Adverse Events	Monitoring for safety of the treatment arm	1 year post procedure

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Boston Scientific Corporation; Society of Interventional Radiology Foundation
• Investigators: Principal Investigator: Claire Kaufman, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 15, 2022

Study Record Updates

• Last Update Posted (Estimated): October 16, 2025
• Last Update Submitted That Met QC Criteria: October 14, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Diseases; Joint Diseases; Peripheral Nervous System Diseases; Foot Diseases; Metatarsalgia; Neuralgia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Morton Neuroma; Surgical Procedures, Operative; Anesthesia and Analgesia; Neurosurgical Procedures; Ablation Techniques; Anesthesia, Conduction; Anesthesia; Denervation; Cryosurgery; Nerve Block
• Other Study ID Numbers: STUDY00024090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data may be shared with other researchers via a secure web based portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes