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

November 3, 2018 updated by: David Spinner, Icahn School of Medicine at Mount Sinai

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryoablation
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.
Device: Cryoablation
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.
Other Names:
  • Iovera
Active Comparator: Lidocaine
Ultrasound guided perineural lidocaine injection. Under ultrasound guidance, roughly 3cc of 2% lidocaine will be injected near the neuroma.
Drug: Lidocaine
Roughly 3cc of lidocaine will be injected near the intermetatarsal neuroma under ultrasound visualization.
Other Names:
  • xylocaine
Placebo Comparator: Saline
Ultrasound guided perineural normal saline injection. Under ultrasound guidance, roughly 3cc of normal saline will be injected near the neuroma.
Drug: Saline
Roughly 3cc of saline will be injected near the intermetatarsal neuroma under ultrasound visualization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Numeric Pain Rating Scale
Time Frame: up to 12 weeks
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower extremity functional scale (LEFS)
Time Frame: up to 12 weeks
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.
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: David Spinner, DO, Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (Estimate)

July 20, 2016

Study Record Updates

Last Update Posted (Actual)

November 6, 2018

Last Update Submitted That Met QC Criteria

November 3, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 16-1139

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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