Cryoablation versus steroid plus lidocaine injection for 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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 105 Years |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT05501262 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Portland, Oregon
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.