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

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Treatments: Lidocaine

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.