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

Primary Purpose

Intermetatarsal Neuroma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cryoablation
Lidocaine
Saline
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Cryoablation

Lidocaine

Saline

Arm Description

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.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale

Secondary Outcome Measures

Lower extremity functional scale (LEFS)
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.

Full Information

First Posted
July 18, 2016
Last Updated
November 3, 2018
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT02838758
Brief Title
Compare Ultrasound Assisted Cold Therapy and Lidocaine Injection to Treat Morton's Neuroma
Official Title
A 3-arm Randomized Controlled Study Comparing Ultrasound-guided Cryoablation, Ultrasound-guided Perineural Lidocaine and Ultrasound-guided Perineural Saline to Treat Intermetatarsal Neuroma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermetatarsal Neuroma
Keywords
Morton's neuroma, Intermetatarsal neuroma, forefoot pain, ultrasound guided cryoablation, ultrasound guided perineural lidocaine injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cryoablation
Arm Type
Experimental
Arm Description
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.
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Ultrasound guided perineural lidocaine injection. Under ultrasound guidance, roughly 3cc of 2% lidocaine will be injected near the neuroma.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Ultrasound guided perineural normal saline injection. Under ultrasound guidance, roughly 3cc of normal saline will be injected near the neuroma.
Intervention Type
Device
Intervention Name(s)
Cryoablation
Other Intervention Name(s)
Iovera
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
xylocaine
Intervention Description
Roughly 3cc of lidocaine will be injected near the intermetatarsal neuroma under ultrasound visualization.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Roughly 3cc of saline will be injected near the intermetatarsal neuroma under ultrasound visualization.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Lower extremity functional scale (LEFS)
Description
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.
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Spinner, DO
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Miller, SJ, Nakra, A. Morton's neuroma. In McGlamry's Comprehensive Textbook of Foot and Ankle Surgery, 231-252, Lippincott, Williams, &Wilkins, New York, 2001
Results Reference
background
PubMed Identifier
21600450
Citation
Peters PG, Adams SB Jr, Schon LC. Interdigital neuralgia. Foot Ankle Clin. 2011 Jun;16(2):305-15. doi: 10.1016/j.fcl.2011.01.010.
Results Reference
background
PubMed Identifier
15266472
Citation
Thomson CE, Gibson JN, Martin D. Interventions for the treatment of Morton's neuroma. Cochrane Database Syst Rev. 2004;2004(3):CD003118. doi: 10.1002/14651858.CD003118.pub2.
Results Reference
background
PubMed Identifier
9167928
Citation
Okafor B, Shergill G, Angel J. Treatment of Morton's neuroma by neurolysis. Foot Ankle Int. 1997 May;18(5):284-7. doi: 10.1177/107110079701800507.
Results Reference
background
PubMed Identifier
11568193
Citation
Coughlin MJ, Pinsonneault T. Operative treatment of interdigital neuroma. A long-term follow-up study. J Bone Joint Surg Am. 2001 Sep;83(9):1321-8.
Results Reference
background
PubMed Identifier
22134434
Citation
Lee KT, Kim JB, Young KW, Park YU, Kim JS, Jegal H. Long-term results of neurectomy in the treatment of Morton's neuroma: more than 10 years' follow-up. Foot Ankle Spec. 2011 Dec;4(6):349-53. doi: 10.1177/1938640011428510. Epub 2011 Dec 1.
Results Reference
background
PubMed Identifier
17054881
Citation
Su E, Di Carlo E, O'Malley M, Bohne WH, Deland JT, Kennedy JG. The frequency of digital artery resection in Morton interdigital neurectomy. Foot Ankle Int. 2006 Oct;27(10):801-3. doi: 10.1177/107110070602701008.
Results Reference
background
PubMed Identifier
26427837
Citation
Tomasian A, Wallace A, Northrup B, Hillen TJ, Jennings JW. Spine Cryoablation: Pain Palliation and Local Tumor Control for Vertebral Metastases. AJNR Am J Neuroradiol. 2016 Jan;37(1):189-95. doi: 10.3174/ajnr.A4521. Epub 2015 Oct 1.
Results Reference
background
PubMed Identifier
25255705
Citation
Hegg RM, Kurup AN, Schmit GD, Weisbrod AJ, Atwell TD, Olivier KR, Moynihan TJ, Callstrom MR. Cryoablation of sternal metastases for pain palliation and local tumor control. J Vasc Interv Radiol. 2014 Nov;25(11):1665-70. doi: 10.1016/j.jvir.2014.08.011. Epub 2014 Sep 23.
Results Reference
background
PubMed Identifier
24972918
Citation
Prologo JD, Passalacqua M, Patel I, Bohnert N, Corn DJ. Image-guided cryoablation for the treatment of painful musculoskeletal metastatic disease: a single-center experience. Skeletal Radiol. 2014 Nov;43(11):1551-9. doi: 10.1007/s00256-014-1939-x. Epub 2014 Jun 28.
Results Reference
background
PubMed Identifier
12400711
Citation
Caporusso EF, Fallat LM, Savoy-Moore R. Cryogenic neuroablation for the treatment of lower extremity neuromas. J Foot Ankle Surg. 2002 Sep-Oct;41(5):286-90. doi: 10.1016/s1067-2516(02)80046-1.
Results Reference
background
PubMed Identifier
19935984
Citation
Campos NA, Chiles JH, Plunkett AR. Ultrasound-guided cryoablation of genitofemoral nerve for chronic inguinal pain. Pain Physician. 2009 Nov-Dec;12(6):997-1000.
Results Reference
background
PubMed Identifier
23988804
Citation
Connelly NR, Malik A, Madabushi L, Gibson C. Use of ultrasound-guided cryotherapy for the management of chronic pain states. J Clin Anesth. 2013 Dec;25(8):634-6. doi: 10.1016/j.jclinane.2013.05.011. Epub 2013 Aug 27.
Results Reference
background
PubMed Identifier
11460801
Citation
Bridges D, Thompson SW, Rice AS. Mechanisms of neuropathic pain. Br J Anaesth. 2001 Jul;87(1):12-26. doi: 10.1093/bja/87.1.12. No abstract available.
Results Reference
background
PubMed Identifier
4827166
Citation
Wall PD, Gutnick M. Ongoing activity in peripheral nerves: the physiology and pharmacology of impulses originating from a neuroma. Exp Neurol. 1974 Jun;43(3):580-93. doi: 10.1016/0014-4886(74)90197-6. No abstract available.
Results Reference
background
PubMed Identifier
10493758
Citation
Amir R, Michaelis M, Devor M. Membrane potential oscillations in dorsal root ganglion neurons: role in normal electrogenesis and neuropathic pain. J Neurosci. 1999 Oct 1;19(19):8589-96. doi: 10.1523/JNEUROSCI.19-19-08589.1999.
Results Reference
background
PubMed Identifier
7965019
Citation
Matzner O, Devor M. Hyperexcitability at sites of nerve injury depends on voltage-sensitive Na+ channels. J Neurophysiol. 1994 Jul;72(1):349-59. doi: 10.1152/jn.1994.72.1.349.
Results Reference
background
PubMed Identifier
18036166
Citation
Han KR, Kim C, Chae YJ, Kim DW. Efficacy and safety of high concentration lidocaine for trigeminal nerve block in patients with trigeminal neuralgia. Int J Clin Pract. 2008 Feb;62(2):248-54. doi: 10.1111/j.1742-1241.2007.01568.x. Epub 2007 Nov 23.
Results Reference
background

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