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

Last updated: August 11, 2022
Sponsor: Oregon Health and Science University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05501262
STUDY00024090
  • Ages 18-105
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Age >18 years
  • Able to consent and complete questionnaires
  • Failure of a four-week trial of conservative therapy (includes orthotics, appropriatefootwear, and/or metatarsal pads)
  • X-ray and ultrasound excluding other pathology and confirming the presence andlocation of a Morton's neuroma

Exclusion

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 Design

Total Participants: 32
Study Start date:
July 25, 2022
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Oregon Health Sciences University

    Portland, Oregon 97239
    United States

    Active - Recruiting

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