Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-17 @ 12:34 PM
Study NCT ID:
NCT02838758
Status:
COMPLETED
Last Update Posted:
2018-11-06
First Post:
2016-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compare Ultrasound Assisted Cold Therapy and Lidocaine Injection to Treat Morton's Neuroma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070607', 'term': 'Morton Neuroma'}], 'ancestors': [{'id': 'D037061', 'term': 'Metatarsalgia'}, {'id': 'D005534', 'term': 'Foot Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003452', 'term': 'Cryosurgery'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-03', 'studyFirstSubmitDate': '2016-07-18', 'studyFirstSubmitQcDate': '2016-07-19', 'lastUpdatePostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Pain Rating Scale', 'timeFrame': 'up to 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Lower extremity functional scale (LEFS)', 'timeFrame': 'up to 12 weeks', '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Morton's neuroma", 'Intermetatarsal neuroma', 'forefoot pain', 'ultrasound guided cryoablation', 'ultrasound guided perineural lidocaine injection'], 'conditions': ['Intermetatarsal Neuroma']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', '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"}, {'pmid': '21600450', 'type': 'BACKGROUND', '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.'}, {'pmid': '15266472', 'type': 'BACKGROUND', '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."}, {'pmid': '9167928', 'type': 'BACKGROUND', '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."}, {'pmid': '11568193', 'type': 'BACKGROUND', '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.'}, {'pmid': '22134434', 'type': 'BACKGROUND', '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."}, {'pmid': '17054881', 'type': 'BACKGROUND', '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."}, {'pmid': '26427837', 'type': 'BACKGROUND', '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.'}, {'pmid': '25255705', 'type': 'BACKGROUND', '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.'}, {'pmid': '24972918', 'type': 'BACKGROUND', '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.'}, {'pmid': '12400711', 'type': 'BACKGROUND', '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.'}, {'pmid': '19935984', 'type': 'BACKGROUND', '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.'}, {'pmid': '23988804', 'type': 'BACKGROUND', '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.'}, {'pmid': '11460801', 'type': 'BACKGROUND', '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.'}, {'pmid': '4827166', 'type': 'BACKGROUND', '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.'}, {'pmid': '10493758', 'type': 'BACKGROUND', '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.'}, {'pmid': '7965019', 'type': 'BACKGROUND', '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.'}, {'pmid': '18036166', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nStudy 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Between the ages of 18 and 80 years old\n* 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.\n* No history of systemic inflammatory conditions such as rheumatoid arthritis\n* 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.\n\nExclusion Criteria:\n\n* Diagnosed complex regional pain syndrome (CRPS)\n* 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\n* Intermetatarsal bursitis\n* Metatarsophalangeal joint instability/capsulitis\n* Metatarsal stress fracture\n* Lumbar radiculopathy\n* Tarsal tunnel syndrome\n* Frieberg's infraction\n* Painful callosities associated with toe deformities\n* Peripheral neuropathy\n* Diabetes mellitus and peripheral vascular diseases\n* Insufficient command of English to complete self-¬report instruments."}, 'identificationModule': {'nctId': 'NCT02838758', 'briefTitle': "Compare Ultrasound Assisted Cold Therapy and Lidocaine Injection to Treat Morton's Neuroma", 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'A 3-arm Randomized Controlled Study Comparing Ultrasound-guided Cryoablation, Ultrasound-guided Perineural Lidocaine and Ultrasound-guided Perineural Saline to Treat Intermetatarsal Neuroma', 'orgStudyIdInfo': {'id': 'GCO 16-1139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cryoablation', '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.', 'interventionNames': ['Device: Cryoablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine', 'description': 'Ultrasound guided perineural lidocaine injection. Under ultrasound guidance, roughly 3cc of 2% lidocaine will be injected near the neuroma.', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Ultrasound guided perineural normal saline injection. Under ultrasound guidance, roughly 3cc of normal saline will be injected near the neuroma.', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Cryoablation', 'type': 'DEVICE', 'otherNames': ['Iovera'], '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.', 'armGroupLabels': ['Cryoablation']}, {'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['xylocaine'], 'description': 'Roughly 3cc of lidocaine will be injected near the intermetatarsal neuroma under ultrasound visualization.', 'armGroupLabels': ['Lidocaine']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'Roughly 3cc of saline will be injected near the intermetatarsal neuroma under ultrasound visualization.', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'David Spinner, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'David Spinner', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}