drugset / Trial / NCT02838758
Compare Ultrasound Assisted Cold Therapy and Lidocaine Injection to Treat Morton's Neuroma
RandomizedCrossoverSingle-blindTreatment
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.
Timeline
- Start
- 2016-07
- Primary completion
- 2018-06-01
- Completion
- 2018-06-01
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lidocaine | Other / unclassified | 3 ml | Subcutaneous |