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NCT Number: NCT05501262

Comparative Effectiveness of Cryoablation 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.

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Key information

Conditions

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

Age range

18 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Lori Russell

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cryoablation

Device

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

Nerve Block

Procedure

Ultrasound and fluoroscopic guided nerve block.

Primary outcomes

  1. Changes in quality of life

    Time frame: 1 year post procedure

    Will be evaluated using the SF-36 Quality of Life Survey

  2. Réponse in pain

    Time frame: 1 year post procedure

    Will be evaluated using the visual analog scale with 0 as no pain and 10 as the word pain imaginable

  3. Changes to function

    Time frame: 1 year post procedure

    Changes to the modified American Orthopedic Foot and Ankle Society Hallux Metatarsophalangeal--Interphalangeal Scale, higher score is less symptomatic

  4. Changes pain and function due to neuroma

    Time frame: 1 year post procedure

    Changes in Neuroma Scale, higher score is less symptomatic

  5. Incidence of Treatment - Emergent Adverse Events

    Time frame: 1 year post procedure

    Monitoring for safety of the treatment arm

Study contacts

Contact information is provided by the study sponsor or research team.

Lori L Russell, MSN BSN RN

CONTACT

[email protected]

503-494-7226

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Boston Scientific Corporation
  • Society of Interventional Radiology Foundation

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Aug 15, 2022
Registry last updated
Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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