Study Summary
This trial suggests that patients with facet mediated cervicogenic headaches may benefit from a repeat cervical facet radiofrequency neurotomy, with a success rate of 86%.
Eligible Conditions
- Facetogenic Headache
- Cervicogenic Neck Pain
- Chronic Shoulder Pain
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 10 Secondary · Reporting Duration: 6 weeks after RF and if the score was 12 or higher repeat monthly up to 12 weeks
Week 12
Changes in Leeds assessment of neuropathic symptoms and signs
Month 12
Adverse events
At least 30% Changes in Pain Score
At least 50% Changes in Pain Score
Changes in Beck's Depression Inventory
Changes in Changes in Global Improvement and Satisfaction
Changes in Changes in Patients self-reported perceived duration of effect
Changes in General Anxiety Disorder Questionnaire
Changes in The Neck Disability Index
Pain Medications
Quality of life measurement: Neck Disability Index
Quality of life measurement: Short Form Brief Pain Inventory
Quality of life measurement: Visual Analogue Scale
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Pulsed Radiofrequency Ablation
1 of 2
Continuous Radiofrequency Ablation
1 of 2
Active Control
88 Total Participants · 2 Treatment Groups
Primary Treatment: Pulsed Radiofrequency Ablation · No Placebo Group · N/A
Pulsed Radiofrequency Ablation
Procedure
ActiveComparator Group · 1 Intervention: Pulsed Radiofrequency Ablation · Intervention Types: ProcedureContinuous Radiofrequency Ablation
Procedure
ActiveComparator Group · 1 Intervention: Pulsed Radiofrequency Ablation · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks after rf and if the score was 12 or higher repeat monthly up to 12 weeks
Who is running the clinical trial?
Allevio Pain Management ClinicLead Sponsor
3 Previous Clinical Trials
266 Total Patients Enrolled
Eligibility Criteria
Age 18 - 90 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have been experiencing pain for more than three months.
You are experiencing pain in your neck, shoulders, or headaches that originate from your neck.
You have tried different treatments for pain relief in the past but did not get satisfactory results or had trouble tolerating them. These treatments include medication, massage therapy, physiotherapy, and others.
Who else is applying?
What state do they live in?
| Quebec | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Allevio Pain Management Clinic | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
- Chang, Min Cheol. 2017. “Effect of Bipolar Pulsed Radiofrequency on Refractory Chronic Cervical Radicular Pain”. Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/md.0000000000006604.
- Gazelka, Halena M, Sarah Knievel, W. David Mauck, Susan Moeschler, Matthew Pingree, Richard Rho, and Tim Lamer. 2014. “Incidence of Neuropathic Pain After Radiofrequency Denervation of the Third Occipital Nerve”. Journal of Pain Research. Informa UK Limited. doi:10.2147/jpr.s60925.
- Erdine, Serdar, Nuri Suleyman Ozyalcin, Ali Cimen, Mehmet Celik, Gul Koknel Talu, and Rian Disci. 2007. “Comparison of Pulsed Radiofrequency with Conventional Radiofrequency in the Treatment of Idiopathic Trigeminal Neuralgia”. European Journal of Pain. Wiley. doi:10.1016/j.ejpain.2006.04.001.
- Dworkin, Robert H., Dennis C. Turk, Kathleen W. Wyrwich, Dorcas Beaton, Charles S. Cleeland, John T. Farrar, Jennifer A. Haythornthwaite, et al.. 2008. “Interpreting the Clinical Importance of Treatment Outcomes in Chronic Pain Clinical Trials: IMMPACT Recommendations”. The Journal of Pain. Elsevier BV. doi:10.1016/j.jpain.2007.09.005.
- Smith, Ashley Dean, Gwendolen Jull, Geoff Schneider, Bevan Frizzell, Robert Allen Hooper, and Michele Sterling. 2014. “Cervical Radiofrequency Neurotomy Reduces Central Hyperexcitability and Improves Neck Movement in Individuals with Chronic Whiplash”. Pain Medicine. Oxford University Press (OUP). doi:10.1111/pme.12262.
- Chang, Min Cheol, and Seoyon Yang. 2022. “Effectiveness of Pulsed Radiofrequency on the Medial Cervical Branches for Cervical Facet Joint Pain”. World Journal of Clinical Cases. Baishideng Publishing Group Inc.. doi:10.12998/wjcc.v10.i22.7720.
- Vanelderen, Pascal, Tom Rouwette, Pieter De Vooght, Martine Puylaert, René Heylen, Kris Vissers, and Jan Van Zundert. 2010. “Pulsed Radiofrequency for the Treatment of Occipital Neuralgia”. Regional Anesthesia and Pain Medicine. BMJ. doi:10.1097/aap.0b013e3181d24713.
- Govind, J. 2003. “Radiofrequency Neurotomy for the Treatment of Third Occipital Headache”. Journal of Neurology, Neurosurgery & Psychiatry. BMJ. doi:10.1136/jnnp.74.1.88.
- Yin, Way, and Nikolai Bogduk. 2008. “The Nature of Neck Pain in a Private Pain Clinic in the United States”. Pain Medicine. Oxford University Press (OUP). doi:10.1111/j.1526-4637.2007.00369.x.
- Fang, Luo, Wang Tao, Lu Jingjing, and Ji Nan. 2014. “Comparison of High-voltage- with Standard-voltage Pulsed Radiofrequency of Gasserian Ganglion in the Treatment of Idiopathic Trigeminal Neuralgia”. Pain Practice. Wiley. doi:10.1111/papr.12227.
- Cohen, Steven P., B. Lee Peterlin, Larry Fulton, Edward T. Neely, Connie Kurihara, Anita Gupta, Jimmy Mali, et al.. 2015. “Randomized, Double-blind, Comparative-effectiveness Study Comparing Pulsed Radiofrequency to Steroid Injections for Occipital Neuralgia or Migraine with Occipital Nerve Tenderness”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/j.pain.0000000000000373.
- Bogduk, Nikolai, and Jayantilal Govind. 2009. “Cervicogenic Headache: An Assessment of the Evidence on Clinical Diagnosis, Invasive Tests, and Treatment”. The Lancet Neurology. Elsevier BV. doi:10.1016/s1474-4422(09)70209-1.
- MacVicar, John, James M. Borowczyk, Anne M. MacVicar, Brigid M. Loughnan, and Nikolai Bogduk. 2012. “Cervical Medial Branch Radiofrequency Neurotomy in New Zealand”. Pain Medicine. Oxford University Press (OUP). doi:10.1111/j.1526-4637.2012.01351.x.
- Husted, Daniel S., Derek Orton, Jerome Schofferman, and Garrett Kine. 2008. “Effectiveness of Repeated Radiofrequency Neurotomy for Cervical Facet Joint Pain”. Journal of Spinal Disorders & Techniques. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/bsd.0b013e318158971f.
- Gil Faclier, Joseph Kay. Cervical facet radiofrequency neurotomy. Techniques in Regional Anesthesia and Pain Management Volume 4, Issue 3, July 2000, Pages 120-125
- Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale, NJ: L. Erlbaum, 1988.
- Dworkin, Robert H., Dennis C. Turk, Kathleen W. Wyrwich, Dorcas Beaton, Charles S. Cleeland, John T. Farrar, Jennifer A. Haythornthwaite, et al.. 2008. “Interpreting the Clinical Importance of Treatment Outcomes in Chronic Pain Clinical Trials: IMMPACT Recommendations”. The Journal of Pain. Elsevier BV. doi:10.1016/j.jpain.2007.09.005.
- Fang, Luo, Wang Tao, Lu Jingjing, and Ji Nan. 2014. “Comparison of High-voltage- with Standard-voltage Pulsed Radiofrequency of Gasserian Ganglion in the Treatment of Idiopathic Trigeminal Neuralgia”. Pain Practice. Wiley. doi:10.1111/papr.12227.
- Falco FJ, Erhart S, Wargo BW, Bryce DA, Atluri S, Datta S, Hayek SM. Systematic review of diagnostic utility and therapeutic effectiveness of cervical facet joint interventions. Pain Physician. 2009 Mar-Apr;12(2):323-44.
- Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.
- Vanelderen P, Rouwette T, De Vooght P, Puylaert M, Heylen R, Vissers K, Van Zundert J. Pulsed radiofrequency for the treatment of occipital neuralgia: a prospective study with 6 months of follow-up. Reg Anesth Pain Med. 2010 Mar-Apr;35(2):148-51. doi: 10.1097/aap.0b013e3181d24713.
- Erdine S, Ozyalcin NS, Cimen A, Celik M, Talu GK, Disci R. Comparison of pulsed radiofrequency with conventional radiofrequency in the treatment of idiopathic trigeminal neuralgia. Eur J Pain. 2007 Apr;11(3):309-13. doi: 10.1016/j.ejpain.2006.04.001. Epub 2006 Jun 9.
- Govind J, King W, Bailey B, Bogduk N. Radiofrequency neurotomy for the treatment of third occipital headache. J Neurol Neurosurg Psychiatry. 2003 Jan;74(1):88-93. doi: 10.1136/jnnp.74.1.88.
- Bogduk N, Govind J. Cervicogenic headache: an assessment of the evidence on clinical diagnosis, invasive tests, and treatment. Lancet Neurol. 2009 Oct;8(10):959-68. doi: 10.1016/S1474-4422(09)70209-1.
- 2020. "Pulsed vs Continuous Radiofrequency Neurotomy for Cervical Facet Joint Mediated Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04124445.
Frequently Asked Questions
Is enrollment currently available for this research study?
"Affirmative. Records found on clinicaltrials.gov reveal that this medical investigation, which was first posted on February 10th 2020, is actively recruiting patients for participation. At 2 different research sites, approximately 88 people are required to join the study." - Anonymous Online Contributor
Unverified Answer
Are elderly persons of advanced age being considered for inclusion in this medical experiment?
"The qualifications for participation in this clinical trial demand that applicants are between 18 and 90 years of age. There are 22 trials specifically catered to minors and 196 studies targeting the elderly population." - Anonymous Online Contributor
Unverified Answer
Are there any restrictions on who can sign up for this medical experiment?
"This clinical trial is seeking 88 participants who suffer from facial-genic headaches and are between 18 to 90 years old." - Anonymous Online Contributor
Unverified Answer
What is the intended outcome of this medical experiment?
"This clinical trial's primary aim is to assess patients' quality of life via the Neck Disability Index. Secondary objectives are changes in Beck's Depression Inventory, a minimum 30% reduction in pain scores as measured by The Neck Disability Index (ranging from 0-10), and alterations in narcotics usage using Morphine Equivalent Dose. Data will be collected at baseline and every 3 months up until 12 months post treatment." - Anonymous Online Contributor
Unverified Answer
How many people are the maximum amount allowed to join this clinical experiment?
"Affirmative. According to clinicaltrials.gov records, this medical study is currently recruiting participants - the initial post was made on February 10th 2020 and the last edit occurred June 22nd 2022. A total of 88 patients need to be recruited across 2 sites." - Anonymous Online Contributor
Unverified Answer