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 is testing cryoablation, a treatment that uses extreme cold to destroy nerve tissue, on middle-aged women with Morton's neuroma who haven't found relief from other treatments. The goal is to see if this method is more effective than steroid injections in reducing pain. Cryoablation is a specialized technique for providing long-term pain relief and has been used in various medical fields since its development in 1961.

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 cryoablation safe for treating Morton's neuroma and other conditions?

Cryoablation, used for treating Morton's neuroma and other nerve-related conditions, is generally considered safe with fewer adverse events compared to other nerve treatments. However, steroid injections for Morton's neuroma can cause side effects like fat pad atrophy (thinning of the fat layer under the skin), which can lead to pain and walking difficulties. ^{1 2 3 4 5}

How is cryoablation treatment different from other treatments for Morton's neuroma?

Cryoablation is unique because it uses extreme cold to destroy nerve tissue, guided by imaging techniques like MRI, which can precisely target the affected area. Unlike steroid injections, which can cause side effects like fat pad atrophy, cryoablation avoids these issues by not involving chemicals that alter tissue structure. ^{3 4 5 6 7}

What data supports the effectiveness of cryoablation and steroid injections as treatments for Morton's neuroma?

Research shows that cryoablation, which uses extreme cold to destroy nerve tissue, has been used successfully in treating Morton's neuroma, as seen in a study involving 20 patients. Additionally, steroid injections, which reduce inflammation, have been found effective in treating Morton's neuromas, with their success sometimes depending on the size of the neuroma. ^{3 5 8 9 10}

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+

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. United States pubmed.ncbi.nlm.nih.gov

Percutaneous MR-Guided Cryoablation of Morton's Neuroma: Rationale and Technical Details After the First 20 Patients. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of corticosteroid injection versus size of plantar interdigital neuroma. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Ultrasound-guided radiofrequency ablation for treatment of Morton's neuroma: initial experience. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Ultrasound-guided radiofrequency ablation in the management of interdigital (Morton's) neuroma. [2022]

5. France pubmed.ncbi.nlm.nih.gov

What factors predict the need for further intervention following corticosteroid injection of Morton's neuroma? [2022]

6. England pubmed.ncbi.nlm.nih.gov

Sonographically guided cryoneurolysis: preliminary experience and clinical outcomes. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Percutaneous cryoablation of chondroblastoma and osteoblastoma in pediatric patients. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Plantar fat pad atrophy after corticosteroid injection for an interdigital neuroma: a case report. [2019]

9. France pubmed.ncbi.nlm.nih.gov

[Regression of Morton neuroma after local injection of steroids]. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Corticosteroid Injection for the Treatment of Morton's Neuroma: A Prospective, Double-Blinded, Randomized, Placebo-Controlled Trial. [2022]