Cryoablation versus steroid plus lidocaine injection for Morton's neuroma
Official 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
Run by Oregon Health and Science University · NCT05501262 · Data updated 2026-11-12
This trial will try whether freezing the nerve (cryoablation) or steroid with lidocaine injections relieve pain and improve function for adults with Morton's neuroma.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 105 Years |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Status | Recruiting |
| Started | July 25, 2022 |
| Main results expected | December 30, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | October 16, 2025 |
| Trial ID | NCT05501262 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with ultrasound-confirmed Morton's neuroma who have failed at least four weeks of conservative therapy and can attend in-person follow-up are ideal candidates.
✕Probably not a fit
People with other foot pathology on imaging, contraindications to cryoablation or steroid/lidocaine injection, or who cannot comply with follow-up are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with imaging-confirmed Morton's neuroma who have not improved with orthotics or other conservative care are randomly assigned to receive either percutaneous cryoablation of the interdigital nerve or a steroid plus lidocaine injection. Procedures and follow-up visits are performed at a single academic center with standardized imaging and pain/function questionnaires collected over time. The study tracks pain relief, functional improvement, and procedure-related complications to compare short- and longer-term outcomes between the two treatments. This head-to-head comparison aims to clarify whether cryoablation offers more durable benefit than injections alone.
Why it matters
Potential benefit: If successful, cryoablation could provide longer-lasting pain relief and reduce the need for repeat injections or surgery for people with Morton's neuroma.
How similar studies have gone: Two small prior studies have reported that cryoablation appears safe and effective for neuropathic foot pain including Morton's neuroma, but larger randomized comparisons are limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Oregon Health Sciences University
Portland, Oregon, United States Recruiting
Study contacts
- Principal investigator: Claire Kaufman — Oregon Health and Science University
- Study coordinator: Lori L Russell, MSN BSN RN
- Email: watsonlo@ohsu.edu
- Phone: 503-494-7226
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.