Musculoskeletal Diseases

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Neoplasms

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Bursitis

Pain

Metatarsalgia

Neuroma

Morton Neuroma

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

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Foot Diseases

Neuralgia

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neurologic Manifestations

Patients with intermetatarsal pain have ultrasound and MRI done

Healthy individuals (no forefoot pain) undergo ultrasound and MRI scan of the forefoot.

MRI of the forefoot with contrast (Gadovist)

MRI with contrast

Ultrasound

Sif B Larsen, MD

The aim of this study is to investigate the incidence of intermetatarsal bursitis and Morton's neuroma in patients with metatarsalgia (i.e. pain in the forefoot) and control subjects by diagnostic imaging with ultrasound and MRI.

In a group of patients with intermetatarsal pain found by an orthopedic surgeon, the investigators want to assess the incidences of intermetatarsal bursitis and Morton's neuroma, using diagnostic imaging; ultrasound and MRI.

The hypothesis is, that intermetatarsal bursitis is an overlooked diagnosis in patients with metatarsalgia. As a result of sparse literature and lack of knowledge about this condition with symptoms mimicking Morton's neuroma, a part of patients diagnosed with Morton's neuroma, suffers from intermetatarsal bursitis instead.

Additionally, the investigators want to evaluate the clinical sign opening toes.

Based on clinical photos of the feet, the investigators want to document the presence of opening toes and investigate if there is a correlation with either intermetatarsal bursitis and/or Morton's neuroma.

This is a diagnostic study with a patient and a control group.

US and MRI of the Forefoot: Intermetatarsal Bursitis or Morton's Neuroma

Ultrasound and MRI of the Forefoot: Intermetatarsal Bursitis or Morton's Neuroma

High intensity on T2 weighted images, low signal on T1. Thin peripheral enhancement on T1 contrast enhanced pictures.

Hypoechoic mass between metatarsal heads closest to dorsal surface of foot. Compressible. Activity on power/color doppler.

Low to Intermediate signal in T1 and T2. Contrast enhancement of the nodular focus.

Hypoechoic mass between metatarsal heads closest to plantar surface of foot. Non-compressible. The interdigital nerve can be seen entering the mass. Close relation to the interdigital artery.

Other pathology than intermetatarsal bursitis or Morton's neuroma.

Presence of opening toes/V-sign/spreading toes.

The Danish Rheumatism Association

Hvidovre University Hospital

Bispebjerg Hospital

Gentofte Hospital

Rigshospitalet, Denmark

Principal Investigator

Dermatologic Agents

All Drugs and Chemicals

Capsaicin

ALGRX 4975

Eric Diamond, D.P.M.

Subjects will have painful primary or post-operative intermetatarsal neuroma. Study drug or placebo will be injected into the space containing the neuroma. Subjects will complete weekly assessments for severity of foot pain, a brief pain inventory, and the amount of pain medication taken. Subjects will be seen for a screening visit, a treatment visit, and two follow-up visits after treatment. The last scheduled visit is one month after treatment. Some subjects may be followed by monthly telephone interviews to assess their level of pain over the six-month period following treatment.

Subjects will have painful primary or post-operative intermetatarsal neuroma. Each subject will be randomly allocated to receive either ALGRX 4975 or placebo in a 1:1 ratio. Study drug or placebo will be injected into the intermetatarsal space containing a painful neuroma. Subjects will complete weekly assessments for the Average Foot Pain Severity, the 7 Interference Items of the BPI, and the number of analgesic units taken. Some subjects may be followed by monthly telephone interviews to assess their level of pain over the six-month period following treatment.

Plasma concentrations will be assessed pre-dose and post dose at 5, 10, 15, 20, 30, and 45 min and at 1, 1.5, 2, 2.5, 3 and 4 hours.

Safety will be assessed at baseline and during the study with adverse events (all visits), vital signs (Visit 2 pre and post-injection and Visit 3 or at early termination), and laboratory assessments (hematology, chemistry, urinalysis) and ECG (Screening and Visit 3 or at early termination). The injection site will be examined and assessed by a 6-point scale for erythema, edema, and hemorrhage before the injection and at 1, 2 and 4 hours after the injection. A pain on injection NRS will be assessed immediately post- injection at 15, 30, and 45 minutes and 1, 2, 3, and 4 hours after study drug administration. A sensory examination of the foot will be performed before the injection and 4 hours after the injection and at the completion of the study. If a subject has injection pain, the foot may be wrapped in ice for up to 20 minutes, analgesic medication may be provided.

ALGRX 4975 in the Treatment of Patients With Morton's Neuroma

A Randomized, Double-Blind, Placebo-Controlled Trial of ALGRX 4975 in Subjects With Painful Intermetatarsal Neuroma

AlgoRx Pharmaceuticals

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Respiratory Tract Infections

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
US and MRI of the Forefoot: Intermetatarsal Bursitis or Morton's Neuroma	NCT05685160	Intermetatarsal... Morton Neuroma Intermetatarsal...	MRI with contra... Ultrasound	18 Years -	Rigshospitalet, Denmark
ALGRX 4975 in the Treatment of Patients With Morton's Neuroma	NCT00130962	Neuroma	ALGRX 4975	18 Years -	AlgoRx Pharmaceuticals
ALGRX 4975 in the Treatment of Patients With Morton's Neuroma	NCT00130962	Neuroma	ALGRX 4975	18 Years -	AlgoRx Pharmaceuticals
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

Spots Global Cancer Trial Database for intermetatarsal neuroma