Cryoablation vs Steroid Injections for Morton's Neuroma

Overseen By Dotter Interventional Institute

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Inability to follow-up, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate procedure

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for Morton's neuroma, a painful foot condition often affecting middle-aged women. The study compares cryoablation, which uses extreme cold to reduce pain, with the standard treatment of steroid injections. It aims to determine which method offers better short- and long-term relief after conservative treatments, such as special shoes or inserts, have failed. Individuals who have tried these basic treatments for at least four weeks and have been diagnosed with Morton's neuroma through imaging may be eligible to join. As an unphased trial, this study provides patients the opportunity to explore innovative treatment options beyond standard care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cryoablation, a procedure that freezes nerve tissue to reduce pain, is safe for treating Morton's neuroma. In two small studies, patients who underwent cryoablation experienced significant pain relief with few side effects. Another study found that cryoablation effectively manages nerve pain in the foot. Overall, patients tolerate cryoablation well, and serious side effects are rare. This makes it a promising treatment for those suffering from the discomfort of Morton's neuroma. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatment for Morton's Neuroma, which typically involves steroid and lidocaine injections to reduce inflammation and pain, cryoablation offers a unique approach by using extreme cold to target and destroy the affected nerve tissue. This technique is minimally invasive and may provide longer-lasting relief by directly addressing the nerve issue rather than just managing symptoms. Researchers are excited about cryoablation because it has the potential to reduce the need for repeated injections and could offer a more definitive solution for patients suffering from this painful condition.

What evidence suggests that cryoablation and steroid injections could be effective for Morton's neuroma?

Research has shown that cryoablation, a treatment under study in this trial, can effectively treat Morton's neuroma. Two small studies found it safe and helpful in reducing pain from this condition. Cryoablation works by freezing the nerve, stopping the pain signals. In contrast, steroid injections, which participants in another arm of this trial will receive, commonly provide long-term pain relief in only about 30% of cases. Cryoablation offers a promising alternative, especially for those who haven't found relief with other treatments. ^{1 2 3 4 6}

Who Is on the Research Team?

Claire Kaufman

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have Morton's neuroma, a painful foot condition, and haven't improved after four weeks of non-surgical treatments like orthotics. Participants must be able to consent and complete surveys. Those with other foot issues on imaging or unable to follow the study plan can't join.

Inclusion Criteria

Able to consent and complete questionnaires

You have tried using special shoe inserts, proper shoes, and/or metatarsal pads for four weeks, but they did not help.

You had an X-ray and ultrasound to confirm the presence and location of a Morton's neuroma, and no other issues were found.

Exclusion Criteria

Inability to follow-up or to comply with the follow-up protocol

You have another medical condition that could explain the symptoms found on imaging tests.

Unwillingness to be randomized

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either steroid and lidocaine injection or steroid and lidocaine injection with cryoablation

Immediate procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Cryoablation
• Steroid

Trial Overview The study compares two treatments for Morton's neuroma: cryoablation (freezing nerves) and steroid injections combined with lidocaine (a numbing agent). It aims to see which method better relieves pain in the short and long term after conservative methods fail.

How Is the Trial Designed?

Group I: Study Experimental Treatment 1 Intervention

Steroid and lidocaine injection with cryoablation

Group II: Standard of Care Active Control 1 Intervention

Steroid and lidocaine injection

Cryoablation is already approved in United States, European Union for the following indications:

Approved in United States as Cryoablation for:

• Liver cancer
• Kidney cancer
• Bone cancer
• Pain management

Approved in European Union as Cryoablation for:

• Liver cancer
• Kidney cancer
• Bone cancer
• Pain management

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Society of Interventional Radiology Foundation

Collaborator

Trials

6

Recruited

2,300+

Published Research Related to This Trial

A case of Morton neuroma was successfully treated with a local steroid injection, resulting in near complete regression of the lesion as shown by follow-up MRI.

This case is notable as it is the first report of such a significant reduction in size of Morton neuroma following steroid infiltration, highlighting the potential efficacy of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Regression of Morton neuroma after local injection of steroids]. Haddad-Zebouni, S., Elia, D., Aoun, N., et al.[2019]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1051044324000393

Comparative Effectiveness of Cryoablation with Steroid ... Cryoablation is efficacious for neuropathic pain and has been shown in 2 small studies to be safe and effective for treatment of Morton neuroma (6,7). The ...

2. jfasap.com jfasap.com/abstractArticleContentBrowse/JFASAP/34042/JPJ/fullText

Cryoablation of Morton's Neuroma: An Early Clinical and ... Cryoablation (CA) has shown promising results; however, there are limited published studies in the literature. The purpose of this study was to assess the ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27189181/

Percutaneous MR-Guided Cryoablation of Morton's Neuroma Lesion size and location, procedural (technical success, procedural time, complications) and clinical outcomes ... Technical success was 100 %.

4. nice.org.uk nice.org.uk/consultations/1849/4/summary-of-key-evidence-on-percutaneous-image-guided-cryoablation-of-peripheral-neuroma-for-chronic

Percutaneous image-guided cryoablation of peripheral ... Key efficacy findings. Number of patients analysed: 20. Clinical outcome in patients with Morton's neuroma. Patient. Pain before treatment. Treatment response.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05501262

Study Details | NCT05501262 | Comparative Effectiveness ... Surgical resection has a reported 51-85% success rate with 14-21% rate of complication; recurrent pain, numbness/loss of sensation, and subsequent stump ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8807464/

Icing the Pain–Ultrasound-Guided Cryoablation of ... Ultrasound-guided cryoablation of a sensitized stump neuroma was effective and safe for pain alleviation with very good long-term results.