Study Summary
This trial is comparing the effectiveness of two different types of radiofrequency ablation (RFA) for treating cervical facet pain. The first type is the conventional RFA, which has been studied and shown to be effective in the past. The second type is a newer RFA called Trident, which is designed to be more efficient and safe while still maintaining a large ablative lesion. The trial will compare the two types of RFA in terms of pain relief, functionality, and patient perception of improvement.
Eligible Conditions
- Cervical Facet Joint Pain
- Neck Pain
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 5 Secondary · Reporting Duration: 3, 6, and 12 months
12 month
Pain response
Month 12
Post Procedure Disability Response
Pain
Post Procedure Patient Impression of Change
After procedure
Procedural Radiation Dose
Procedure discomfort
Procedure time
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Conventional Cervical Medial Branch Radiofrequency Ablation
1 of 2
Trident Cervical Medial Branch Radiofrequency Ablation
1 of 2
Active Control
80 Total Participants · 2 Treatment Groups
Primary Treatment: Conventional Cervical Medial Branch Radiofrequency Ablation · No Placebo Group · N/A
Conventional Cervical Medial Branch Radiofrequency Ablation
Procedure
ActiveComparator Group · 1 Intervention: Cervical Medial Branch Radiofrequency Ablation · Intervention Types: ProcedureTrident Cervical Medial Branch Radiofrequency Ablation
Procedure
ActiveComparator Group · 1 Intervention: Cervical Medial Branch Radiofrequency Ablation · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3, 6, and 12 months
Who is running the clinical trial?
University of UtahLead Sponsor
1,000 Previous Clinical Trials
1,782,158 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a positive response to the diagnostic MBB with lidocaine and bupivacaine.
You have neck pain for at least 3 months.
References
- McDonald, Greg J., Susan M. Lord, and Nikolai Bogduk. 1999. “Long-term Follow-up of Patients Treated with Cervical Radiofrequency Neurotomy for Chronic Neck Pain”. Neurosurgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00006123-199907000-00015.
- Cosman, Eric R., Jr, Joseph R. Dolensky, and Ryan A. Hoffman. 2014. “Factors That Affect Radiofrequency Heat Lesion Size”. Pain Medicine. Oxford University Press (OUP). doi:10.1111/pme.12566.
- Finlayson, Roderick J., Atikun Thonnagith, Maria Francisca Elgueta, Jordi Perez, John-Paul B. Etheridge, and De Q.H. Tran. 2017. “Ultrasound-guided Cervical Medial Branch Radiofrequency Neurotomy”. Regional Anesthesia and Pain Medicine. BMJ. doi:10.1097/aap.0000000000000506.
- Lord, Susan M., Leslie Barnsley, Barbara J. Wallis, Gregory J. McDonald, and Nikolai Bogduk. 1996. “Percutaneous Radio-frequency Neurotomy for Chronic Cervical Zygapophyseal-joint Pain”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm199612053352302.
- Bogduk, Nikolai, David J. Kennedy, Yakov Vorobeychik, and Andrew Engel. 2017. “Guidelines for Composing and Assessing a Paper on Treatment of Pain”. Pain Medicine. Oxford University Press (OUP). doi:10.1093/pm/pnx121.
- Pool, Jan J. M., Raymond W. J. G. Ostelo, Jan L. Hoving, Lex M. Bouter, and Henrica C. W. de Vet. 2007. “Minimal Clinically Important Change of the Neck Disability Index and the Numerical Rating Scale for Patients with Neck Pain”. Spine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/brs.0b013e31815cf75b.
- Chow, Jeffrey T. Y., Timothy P. Turkstra, Edmund Yim, and Philip M. Jones. 2018. “Sample Size Calculations for Randomized Clinical Trials Published in Anesthesiology Journals: A Comparison of 2010 Versus 2016”. Canadian Journal of Anesthesia/journal Canadien D'anesthésie. Springer Science and Business Media LLC. doi:10.1007/s12630-018-1109-z.
- Barnsley, Les. 2005. “Percutaneous Radiofrequency Neurotomy for Chronic Neck Pain: Outcomes in a Series of Consecutive Patients”. Pain Medicine. Oxford University Press (OUP). doi:10.1111/j.1526-4637.2005.00047.x.
- Bogduk N E. International Spine Intervention Society. Cervical medial branch thermal radiofrequency neurotomy. Practice Guidelines: Spinal Diagnostic and Treatment Procedures, 2nd edition. 2013. 165-217 p.
- Kovacs, Francisco M, The Spanish Back Pain Research Network, Víctor Abraira, Ana Royuela, Josep Corcoll, Luis Alegre, Miquel Tomás, et al.. 2008. “Minimum Detectable and Minimal Clinically Important Changes for Pain in Patients with Nonspecific Neck Pain”. BMC Musculoskeletal Disorders. Springer Science and Business Media LLC. doi:10.1186/1471-2474-9-43.
- Ebraheim, Nabil A., Steve T. Haman, Rongming Xu, and Richard A. Yeasting. 1998. “The Anatomic Location of the Dorsal Ramus of the Cervical Nerve and Its Relation to the Superior Articular Process of the Lateral Mass”. Spine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00007632-199809150-00009.
- Cohen, Steven P., Scott A. Strassels, Connie Kurihara, Ivan K. Lesnick, Steven R. Hanling, Scott R. Griffith, Chester C. Buckenmaier, and Conner Nguyen. 2011. “Does Sensory Stimulation Threshold Affect Lumbar Facet Radiofrequency Denervation Outcomes? A Prospective Clinical Correlational Study”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0b013e31822dd379.
- BOGDUK, NIKOLAI. 1982. “The Clinical Anatomy of the Cervical Dorsal Rami”. Spine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00007632-198207000-00001.
- Walker, Esteban, and Amy S. Nowacki. 2010. “Understanding Equivalence and Noninferiority Testing”. Journal of General Internal Medicine. Springer Science and Business Media LLC. doi:10.1007/s11606-010-1513-8.
- Harden, R. Norman, Stephan R. Weinland, Thomas A. Remble, Timothy T. Houle, Sean Colio, Susan Steedman, and William G. Kee. 2005. “Medication Quantification Scale Version III: Update in Medication Classes and Revised Detriment Weights by Survey of American Pain Society Physicians”. The Journal of Pain. Elsevier BV. doi:10.1016/j.jpain.2005.01.350.
- Ayearst, Lindsay E, Zoltan Harsanyi, and Kenneth J Michalko. 2012. “The Pain and Sleep Questionnaire Three-item Index (PSQ-3): A Reliable and Valid Measure of the Impact of Pain on Sleep in Chronic Nonmalignant Pain of Various Etiologies”. Pain Research and Management. Hindawi Limited. doi:10.1155/2012/635967.
- Luedtke, Kerstin, Annika Basener, Stephanie Bedei, Rene Castien, Aleksander Chaibi, Deborah Falla, Cesar Fernández-de-las-Peñas, et al.. 2020. “Outcome Measures for Assessing the Effectiveness of Non-pharmacological Interventions in Frequent Episodic or Chronic Migraine: A Delphi Study”. BMJ Open. BMJ. doi:10.1136/bmjopen-2019-029855.
- Julious, Steven A.. 2004. “Sample Sizes for Clinical Trials with Normal Data”. Statistics in Medicine. Wiley. doi:10.1002/sim.1783.
- Barnsley L. Percutaneous radiofrequency neurotomy for chronic neck pain: outcomes in a series of consecutive patients. Pain Med. 2005 Jul-Aug;6(4):282-6. doi: 10.1111/j.1526-4637.2005.00047.x.
- Bogduk N. The clinical anatomy of the cervical dorsal rami. Spine (Phila Pa 1976). 1982 Jul-Aug;7(4):319-30. doi: 10.1097/00007632-198207000-00001.
- Harden RN, Weinland SR, Remble TA, Houle TT, Colio S, Steedman S, Kee WG; American Pain Society Physicians. Medication Quantification Scale Version III: update in medication classes and revised detriment weights by survey of American Pain Society Physicians. J Pain. 2005 Jun;6(6):364-71. doi: 10.1016/j.jpain.2005.01.350.
- Ebraheim NA, Haman ST, Xu R, Yeasting RA. The anatomic location of the dorsal ramus of the cervical nerve and its relation to the superior articular process of the lateral mass. Spine (Phila Pa 1976). 1998 Sep 15;23(18):1968-71. doi: 10.1097/00007632-199809150-00009.
- Walker E, Nowacki AS. Understanding equivalence and noninferiority testing. J Gen Intern Med. 2011 Feb;26(2):192-6. doi: 10.1007/s11606-010-1513-8. Epub 2010 Sep 21.
- Lord SM, Barnsley L, Wallis BJ, McDonald GJ, Bogduk N. Percutaneous radio-frequency neurotomy for chronic cervical zygapophyseal-joint pain. N Engl J Med. 1996 Dec 5;335(23):1721-6. doi: 10.1056/NEJM199612053352302.
- Luedtke K, Basener A, Bedei S, Castien R, Chaibi A, Falla D, Fernandez-de-Las-Penas C, Gustafsson M, Hall T, Jull G, Kropp P, Madsen BK, Schaefer B, Seng E, Steen C, Tuchin P, von Piekartz H, Wollesen B. Outcome measures for assessing the effectiveness of non-pharmacological interventions in frequent episodic or chronic migraine: a Delphi study. BMJ Open. 2020 Feb 12;10(2):e029855. doi: 10.1136/bmjopen-2019-029855.
- Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. doi: 10.1002/sim.1783.
- Ayearst L, Harsanyi Z, Michalko KJ. The Pain and Sleep Questionnaire three-item index (PSQ-3): a reliable and valid measure of the impact of pain on sleep in chronic nonmalignant pain of various etiologies. Pain Res Manag. 2012 Jul-Aug;17(4):281-90. doi: 10.1155/2012/635967.
- McDonald GJ, Lord SM, Bogduk N. Long-term follow-up of patients treated with cervical radiofrequency neurotomy for chronic neck pain. Neurosurgery. 1999 Jul;45(1):61-7; discussion 67-8. doi: 10.1097/00006123-199907000-00015.
- Kovacs FM, Abraira V, Royuela A, Corcoll J, Alegre L, Tomas M, Mir MA, Cano A, Muriel A, Zamora J, Del Real MT, Gestoso M, Mufraggi N; Spanish Back Pain Research Network. Minimum detectable and minimal clinically important changes for pain in patients with nonspecific neck pain. BMC Musculoskelet Disord. 2008 Apr 10;9:43. doi: 10.1186/1471-2474-9-43.
- Pool JJ, Ostelo RW, Hoving JL, Bouter LM, de Vet HC. Minimal clinically important change of the Neck Disability Index and the Numerical Rating Scale for patients with neck pain. Spine (Phila Pa 1976). 2007 Dec 15;32(26):3047-51. doi: 10.1097/BRS.0b013e31815cf75b.
- Taylor Burnham 2022. "Trident Multi-tined Cannula for Cervical MBRFA Compared to the Conventional Cannula". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05424198.
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