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

NCT05501262 | Recruiting DMC FDA Device

• 1 other identifier: STUDY00024090
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Morton Neuroma

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Steroid and lidocaine injection

Procedure: Nerve block

Study

EXPERIMENTAL

Steroid and lidocaine injection with cryoablation

Device: Cryoablation

Interventions

Cryoablation DEVICE

Image (ultrasound and fluoroscopic guided) cryoablation will be performed of the Morton's neuroma after nerve block.

Study

Nerve block PROCEDURE

Ultrasound and fluoroscopic guided nerve block.

Standard of Care

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Boston Scientific Corporation: collaborator
• Society of Interventional Radiology Foundation: collaborator

Study Sites (1)

Oregon Health Sciences University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Morton Neuroma

Interventions

Cryosurgery; Nerve Block

Condition Hierarchy (Ancestors)

Metatarsalgia; Foot Diseases; Musculoskeletal Diseases; Joint Diseases; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures

Study Officials

• Claire Kaufman

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lori L Russell, MSN BSN RN

CONTACT

503-494-7226; watsonlo@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 15, 2022
• Study Start: July 25, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)