CompletedPhase 1

Compare Ultrasound Assisted Cold Therapy and Lidocaine Injection to Treat Morton's Neuroma

United States10 participantsStarted 2016-07

Plain-language summary

The purpose of this study is to evaluate the effectiveness of a device that delivers freezing temperature compared to injecting lidocaine (an anesthetic medication) in providing pain relief to patients with disorganized nerve bundle between the toes, also known as Morton's neuroma. The same ultrasound technology that the obstetricians use to visualize a fetus inside a pregnant woman will be used to help the study physician to locate the Morton's neuroma while precisely delivering the freezing temperature and lidocaine near the nerve.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Between the ages of 18 and 80 years old * Magnetic Resonance Imaging (MRI) confirmed diagnosis of Morton's neuroma - Refractory (greater than 3 month) symptoms to multiple conservative management, including physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDS) and foot orthotics. * No history of systemic inflammatory conditions such as rheumatoid arthritis * Able to give written informed consent - Subject has been on a stable dose of analgesic mediation (or not on analgesic medication) for at least 3 weeks and is agreeable to remaining on current regimen for the duration of the study. Exclusion Criteria: * Diagnosed complex regional pain syndrome (CRPS) * Pregnancy - History of intolerance, hypersensitivity or known allergy to lidocaine - Recent history of recent surgical intermetatarsal neuronectomy (within previous 6 months) - Coagulation disorder - Current infection * Intermetatarsal bursitis * Metatarsophalangeal joint instability/capsulitis * Metatarsal stress fracture * Lumbar radiculopathy * Tarsal tunnel syndrome * Frieberg's infraction * Painful callosities associated with toe deformities * Peripheral neuropathy * Diabetes mellitus and peripheral vascular diseases * Insufficient command of English to complete self-¬report instruments.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Numeric Pain Rating Scale

Timeframe: up to 12 weeks

Trial details

NCT IDNCT02838758

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06-01

View on ClinicalTrials.gov More Intermetatarsal Neuroma trials