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

NCT02838758 | Completed Phase 1 DMC

• 1 other identifier: GCO 16-1139
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermetatarsal Neuroma

Keywords

Morton's neuroma; Intermetatarsal neuroma; forefoot pain; ultrasound guided cryoablation; ultrasound guided perineural lidocaine injection

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating Scale

  up to 12 weeks

Secondary Outcomes (1)

• Lower extremity functional scale (LEFS)

  up to 12 weeks

Study Arms (3)

Cryoablation

EXPERIMENTAL

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

Lidocaine

ACTIVE COMPARATOR

Ultrasound guided perineural lidocaine injection. Under ultrasound guidance, roughly 3cc of 2% lidocaine will be injected near the neuroma.

Drug: Lidocaine

Saline

PLACEBO COMPARATOR

Ultrasound guided perineural normal saline injection. Under ultrasound guidance, roughly 3cc of normal saline will be injected near the neuroma.

Drug: Saline

Interventions

Cryoablation DEVICE

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.

Also known as: Iovera

Cryoablation

Lidocaine DRUG

Roughly 3cc of lidocaine will be injected near the intermetatarsal neuroma under ultrasound visualization.

Also known as: xylocaine

Lidocaine

Saline DRUG

Roughly 3cc of saline will be injected near the intermetatarsal neuroma under ultrasound visualization.

Saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (18)

• 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

  BACKGROUND

• 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.

  PMID: 21600450 BACKGROUND

• 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.

  PMID: 15266472 BACKGROUND

• 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.

  PMID: 9167928 BACKGROUND

• 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.

  PMID: 11568193 BACKGROUND

• 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.

  PMID: 22134434 BACKGROUND

• 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.

  PMID: 17054881 BACKGROUND

• 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.

  PMID: 26427837 BACKGROUND

• 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.

  PMID: 25255705 BACKGROUND

• 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.

  PMID: 24972918 BACKGROUND

• 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.

  PMID: 12400711 BACKGROUND

• 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.

  PMID: 19935984 BACKGROUND

• 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.

  PMID: 23988804 BACKGROUND

• 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.

  PMID: 11460801 BACKGROUND

• 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.

  PMID: 4827166 BACKGROUND

• 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.

  PMID: 10493758 BACKGROUND

• 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.

  PMID: 7965019 BACKGROUND

• 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.

  PMID: 18036166 BACKGROUND

MeSH Terms

Conditions

Morton Neuroma

Interventions

Cryosurgery; Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Metatarsalgia; Foot Diseases; Musculoskeletal Diseases; Joint Diseases; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• David Spinner, DO

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 20, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)