Actively Recruiting

Phase Not Applicable
Age: 18Years - 105Years
All Genders
Healthy Volunteers
NCT05501262

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

Led by Oregon Health and Science University · Updated on 2025-10-16

32

Participants Needed

1

Research Sites

283 weeks

Total Duration

On this page

Sponsors

O

Oregon Health and Science University

Lead Sponsor

B

Boston Scientific Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 105Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Able to consent and complete questionnaires
  • Failed a four-week trial of conservative therapy including orthotics, suitable footwear, or metatarsal pads
  • X-ray and ultrasound confirming presence and location of Morton's neuroma and excluding other conditions
Not Eligible

You will not qualify if you...

  • Unable to follow-up or comply with follow-up schedule
  • Contraindications to cryoablation or lidocaine/steroid injection
  • Other conditions found on imaging that could explain symptoms
  • Unwilling to be randomized to treatment groups

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Oregon Health Sciences University

Portland, Oregon, United States, 97239

Actively Recruiting

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Research Team

L

Lori L Russell, MSN BSN RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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