RecruitingNot ApplicableNCT05501262

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


Sponsor

Oregon Health and Science University

Enrollment

32 participants

Start Date

Jul 25, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 105 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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

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Interventions

DEVICECryoablation

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

PROCEDURENerve block

Ultrasound and fluoroscopic guided nerve block.


Locations(1)

Oregon Health Sciences University

Portland, Oregon, United States

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NCT05501262