Symptoms and General Pathology

All Conditions

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Neoplasms

Musculoskeletal Diseases

Nervous System Diseases

Skin and Connective Tissue Diseases

Pain

Respiratory Tract Infections

Neuroma

Morton Neuroma

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Metatarsalgia

Foot Diseases

Joint Diseases

Neuralgia

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neurologic Manifestations

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Lidocaine

Nitrous Oxide

Anesthetics

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Ultrasound guided perineural cryoablation. The mechanism of therapeutic cryoablation involves using short and repeated cycles of freezing and thawing to cause axonal degeneration and disrupt neuronal activity without damage to epineurium and perineurium.

Ultrasound guided perineural lidocaine injection. Under ultrasound guidance, roughly 3cc of 2% lidocaine will be injected near the neuroma.

Ultrasound guided perineural normal saline injection. Under ultrasound guidance, roughly 3cc of normal saline will be injected near the neuroma.

A minimally invasive cryoablation device. It delivers focused nitrous oxide to the target tissue via a 22-gauge needle to create an approximately 9.4mm by 5.4mm spherical freezing zone of temperature between -20 to -100° C.

Cryoablation

Roughly 3cc of lidocaine will be injected near the intermetatarsal neuroma under ultrasound visualization.

Roughly 3cc of saline will be injected near the intermetatarsal neuroma under ultrasound visualization.

Saline

David Spinner, DO

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.

This study will be a 3-arm randomized single-blinded placebo controlled study in which human subjects with intermetatarsal neuralgia will receive subcutaneous normal saline or subcutaneous lidocaine or ultrasound guided cryoablation. The first follow up will take place 4 weeks post procedure to monitor the magnitude and duration of pain relief. Subjects will then be crossed over. Those who had received saline or lidocaine will receive ultrasound guided cryoablation. Individuals, who had previously been given ultrasound guided cryoablation without any improvement, may opt for another denervation procedure at 4 weeks. All of the participants will be followed up at 3 months post procedure to determine the magnitude and duration of pain relief.

Study procedures will be conducted by the principle investigator who is a Board Certified pain management attending physician and an expert in performing ultrasonography guided interventions The cryoablation device is routinely used to treat various painful pathologies at Mount Sinai and Beth Israel pain management offices. The device manual and instructions will be available at both locations. All research staff has prior experience working with individuals with foot and ankle injuries at Mount Sinai.

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

A 3-arm Randomized Controlled Study Comparing Ultrasound-guided Cryoablation, Ultrasound-guided Perineural Lidocaine and Ultrasound-guided Perineural Saline to Treat Intermetatarsal Neuroma

A 20-item instrument current level of difficulty with each activity. All 20 items are scored with a maximum score 4 for each item. Scoring ranges from 0-80. The lower the score the higher the disability.

Icahn School of Medicine at Mount Sinai

Associate Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Compare Ultrasound Assisted Cold Therapy and Lidocaine Injection to Treat Morton's Neuroma	NCT02838758	Intermetatarsal...	Cryoablation Lidocaine Saline	18 Years - 80 Years	Icahn School of Medicine at Mount Sinai
Compare Ultrasound Assisted Cold Therapy and Lidocaine Injection to Treat Morton's Neuroma	NCT02838758	Intermetatarsal...	Cryoablation Lidocaine Saline	18 Years - 80 Years	Icahn School of Medicine at Mount Sinai

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