NCT05501262 Comparative Effectiveness of Cryoablation Versus Steroid and Lidocaine Alone for Treatment of Morton's Neuroma
| NCT ID | NCT05501262 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oregon Health and Science University |
| Condition | Morton Neuroma |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2022-07-25 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2022-07-25 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Claire Kaufman
PRINCIPAL INVESTIGATOR
Oregon Health and Science University
Frequently Asked Questions
Who can join the NCT05501262 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 105 Years, studying Morton Neuroma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05501262 currently recruiting?
Yes, NCT05501262 is actively recruiting participants. Contact the research team at watsonlo@ohsu.edu for enrollment information.
Where is the NCT05501262 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT05501262 clinical trial?
NCT05501262 is sponsored by Oregon Health and Science University. The principal investigator is Claire Kaufman at Oregon Health and Science University. The trial plans to enroll 32 participants.