Morton NeuromaNCT05501262
Comparative Effectiveness of Cryoablation Versus Steroid and Lidocaine Alone for Treatment of Morton's Neuroma
A study testing Cryoablation and Nerve block in people with Morton Neuroma, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Morton Neuroma
- What is being tested?
- Cryoablation and Nerve block
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health Sciences University
Portland, Oregon, 97239
Lori Russell
About this study
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
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.
- Conditions
- Morton Neuroma
- Being tested
- Cryoablation, Nerve block
- Medical subject headings
- Morton Neuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationDevice
Image (ultrasound and fluoroscopic guided) cryoablation will be performed of the Morton's neuroma after nerve block.
Nerve blockProcedure or surgery
Ultrasound and fluoroscopic guided nerve block.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Steroid and lidocaine injection Receives: Procedure: Nerve block |
| Study | Experimental | Steroid and lidocaine injection with cryoablation Receives: Device: Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in quality of life
Will be evaluated using the SF-36 Quality of Life Survey
Measured: 1 year post procedure
Réponse in pain
Will be evaluated using the visual analog scale with 0 as no pain and 10 as the word pain imaginable
Measured: 1 year post procedure
Changes to function
Changes to the modified American Orthopedic Foot and Ankle Society Hallux Metatarsophalangeal--Interphalangeal Scale, higher score is less symptomatic
Measured: 1 year post procedure
Changes pain and function due to neuroma
Changes in Neuroma Scale, higher score is less symptomatic
Measured: 1 year post procedure
Incidence of Treatment - Emergent Adverse Events
Monitoring for safety of the treatment arm
Measured: 1 year post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start25 Jul 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morton NeuromaStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation, Society of Interventional Radiology Foundation
- Responsible party
- Principal investigator, Claire Kaufman, Oregon Health and Science University
- Investigators
- Claire Kaufman, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501262
- Sponsor's protocol ID
- STUDY00024090
- Status last verified
- Oct 2025
- First submitted
- 8 Aug 2022
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Anonymized data may be shared with other researchers via a secure web based portal.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05501262
- Acronym / sponsor ID
- STUDY00024090
- Conditions
- Morton Neuroma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation, Society of Interventional Radiology Foundation
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Procedure: Nerve blockSteroid and lidocaine injection |
| Study | Experimental | Device: CryoablationSteroid and lidocaine injection with cryoablation |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoablationImage (ultrasound and fluoroscopic guided) cryoablation will be performed of the Morton's neuroma after nerve block. | Device | Study |
| Nerve blockUltrasound and fluoroscopic guided nerve block. | Procedure or surgery | Standard of Care |
Primary outcome
Changes in quality of life
Time frame: 1 year post procedure
Will be evaluated using the SF-36 Quality of Life Survey
Réponse in pain
Time frame: 1 year post procedure
Will be evaluated using the visual analog scale with 0 as no pain and 10 as the word pain imaginable
Changes to function
Time frame: 1 year post procedure
Changes to the modified American Orthopedic Foot and Ankle Society Hallux Metatarsophalangeal--Interphalangeal Scale, higher score is less symptomatic
Changes pain and function due to neuroma
Time frame: 1 year post procedure
Changes in Neuroma Scale, higher score is less symptomatic
Incidence of Treatment - Emergent Adverse Events
Time frame: 1 year post procedure
Monitoring for safety of the treatment arm
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Individual participant dataSharing planned: Yes. Anonymized data may be shared with other researchers via a secure web based portal.
Related trials for Morton Neuroma
Not yet recruitingPhase 2
NAC-REPAIR for Post-surgical Pain
Carpal Tunnel Surgery, Trigger Finger Disorder
Enrolling by invitation
US and MRI of the Forefoot: Intermetatarsal Bursitis or Morton's Neuroma
Intermetatarsal Bursitis, Morton Neuroma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claire Kaufman principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation and Nerve block in people with Morton Neuroma, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lori L Russell, MSN BSN RN (503-494-7226, watsonlo@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in quality of life (time frame: 1 year post procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.