Compare Ultrasound Assisted Cold Therapy and Lidocaine Injection to Treat Morton's Neuroma
Intermetatarsal Neuroma
About this trial
This is an interventional treatment trial for Intermetatarsal Neuroma focused on measuring Morton's neuroma, Intermetatarsal neuroma, forefoot pain, ultrasound guided cryoablation, ultrasound guided perineural lidocaine injection
Eligibility Criteria
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.
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
Cryoablation
Lidocaine
Saline
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.