Pulsed vs Continuous Radiofrequency Neurotomy for Cervical Facet Joint Mediated Pain

NCT04124445 | Unknown DMC

• 1 other identifier: 16327-16:325610-06-2019
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

Brief Summary

Different studies have revealed different success rates and patient satisfaction after cervical facet C-RF. In a study on 32 patients, with 15 months follow up, 25% had complete pain relief (8). Another study had shown mean pain relief of 12.5 months and 11.5 months following a repeat procedure, with an effectiveness of 95% in 47 patients (8). In one study a success rate of 88% after first RF, and 86% following a repeat RF in 49 patients with facet mediated cervicogenic headache. They regarded the absence of anesthesia in the distribution of the 3rd occipital nerve, a technical failure (9). In a study from New Zealand, demonstrated cervical facet RF as the sole treatment modality, produced 61% -74% complete pain relief with a median duration of 15-17 months in patients who had responded to facet joints diagnostic block (10). One more study in 2012 has demonstrated high voltage P-RF had a higher short-term effect compare to usual voltage, but results are still lower than C-RF (11). A double blind randomized prospective study has illustrated P-RF did not show any success rate in 6 months pain control, whereas C-RF had 95% pain control for trigeminal neuralgia (12). Cohen in a recent study has compared P-RF with steroid injection for occipital neuralgia or migraine with occipital nerve tenderness (13). Six weeks pain relief was 61% in P-RF group, and 36% in steroid injection group, with a positive outcome of 34%, and 26% respectively (13). One study on 2010 had reached to 52.6%, 6 months pain improvement on occipital neuralgia (14).

Conditions

Faceto-genic Neck Pain; Shoulder Pain Chronic; Faceto-genic Headache

Keywords

Faceto-genic Cervical pain; Chronic pain; Pulsed Radiofrequency ablation; Continues Radiofrequency ablation; Medial Brunch Block

Outcome Measures

Primary Outcomes (3)

• Quality of life measurement: Visual Analogue Scale

  Changes in Visual Analogue Scale (VAS), between minimum of zero and maximum of ten

  Beginning of the study , and every 3 months up to 12 months

• Quality of life measurement: Neck Disability Index

  Changes in the Neck Disability Index - AAOS(NDI\_AAOS)

  Beginning of the study , and every 3 months up to 12 months

• Quality of life measurement: Short Form Brief Pain Inventory

  Changes in the Short Form Brief Pain Inventory (SF-BPI), between minimum of zero and maximum of ten

  Beginning of the study , and every 3 months up to 12 months

Secondary Outcomes (14)

• At least 30% Changes in Pain Score

  Beginning of the study , and every 3 months up to 12 months

• At least 30% Changes in Pain Score

  Beginning of the study , and every 3 months up to 12 months

• At least 30% Changes in Pain Score

  Beginning of the study , and every 3 months up to 12 months

• At least 50% Changes in Pain Score

  Beginning of the study , and every 3 months up to 12 months

• At least 50% Changes in Pain Score

  Beginning of the study , and every 3 months up to 12 months

Study Arms (2)

Pulsed Radiofrequency Ablation

ACTIVE COMPARATOR

Radiofrequency ablation of sensory nerves at minimum 3 levels of cervical spine with Maximum allowable temperature 50° rotation: 90.; Pulse rate: 3 Hz; pulse duration: 50 ms; 3 minutes

Procedure: Pulsed Radiofrequency Ablation

Continuous Radiofrequency Ablation

ACTIVE COMPARATOR

Radiofrequency ablation of sensory nerves at minimum 3 levels of cervical spine, burn will be made at 80° for 60 seconds.

Procedure: Pulsed Radiofrequency Ablation

Interventions

Pulsed Radiofrequency Ablation PROCEDURE

Radiofrequency ablation, also called rhizotomy, is a nonsurgical, minimally invasive procedure that uses heat to reduce or stop the transmission of pain. Radiofrequency waves ablate, or "burn," the nerve that is causing the pain, essentially eliminating the transmission of pain signals to the brain.

Also known as: Continuous Radiofrequency Ablation

Continuous Radiofrequency Ablation; Pulsed Radiofrequency Ablation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-90;
• Pain duration \> 3 months
• Cervical, Shoulder pain or cevicogenic Headache per Pain Diagram;
• Two single blinded facet medial branch blocks (MBB) performed 30 days prior to the facet RF;
• Subjects show 50% and more pain relief after each MBB (using VAS for this assessment);
• Unsuccessful or poorly tolerated previous treatments including: pain control medications, chiropractic, osteopathy, massage therapy, physiotherapy, acupuncture, aqua therapy, Botox injection, and trigger point injection;

You may not qualify if:

• Non-English speakers;
• Refusal to sign informed consent;
• Less than 50% pain relief after MBB (using VAS);
• Variation in the dose of concomitant pain control medication less than 4 weeks before the procedure;
• Allergy to medication or radiology contrast;
• Patients with coagulation issues, those currently using anticoagulants and didn't stop them based on Allevio clinic's policy for anticoagulants;
• Pregnant patients;
• Any pain interventions including previous RF, MBB, infusions 90 days prior to the first MBB for the same area (Except failed Botox injection, and trigger point injection);

Sponsors & Collaborators

• Allevio Pain Management Clinic: lead

Study Sites (2)

Allevio Pain Management Clinic

Toronto, Ontario, M3B 3S6, Canada

RECRUITING

Allevio Pain Management

Toronto, Ontario, M3B 3S6, Canada

RECRUITING

Related Publications (16)

• Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale, NJ: L. Erlbaum, 1988.

  BACKGROUND

• 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.

  PMID: 19305483 RESULT

• Yin W, Bogduk N. The nature of neck pain in a private pain clinic in the United States. Pain Med. 2008 Mar;9(2):196-203. doi: 10.1111/j.1526-4637.2007.00369.x.

  PMID: 18298702 RESULT

• Gil Faclier, Joseph Kay. Cervical facet radiofrequency neurotomy. Techniques in Regional Anesthesia and Pain Management Volume 4, Issue 3, July 2000, Pages 120-125

  RESULT

• Smith AD, Jull G, Schneider G, Frizzell B, Hooper RA, Sterling M. Cervical radiofrequency neurotomy reduces central hyperexcitability and improves neck movement in individuals with chronic whiplash. Pain Med. 2014 Jan;15(1):128-41. doi: 10.1111/pme.12262. Epub 2013 Oct 18.

  PMID: 24138594 RESULT

• 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.

  PMID: 19747657 RESULT

• Chang MC. Effect of bipolar pulsed radiofrequency on refractory chronic cervical radicular pain: A report of two cases. Medicine (Baltimore). 2017 Apr;96(15):e6604. doi: 10.1097/MD.0000000000006604.

  PMID: 28403104 RESULT

• Gazelka HM, Knievel S, Mauck WD, Moeschler SM, Pingree MJ, Rho RH, Lamer TJ. Incidence of neuropathic pain after radiofrequency denervation of the third occipital nerve. J Pain Res. 2014 Apr 10;7:195-8. doi: 10.2147/JPR.S60925. eCollection 2014.

  PMID: 24748815 RESULT

• Husted DS, Orton D, Schofferman J, Kine G. Effectiveness of repeated radiofrequency neurotomy for cervical facet joint pain. J Spinal Disord Tech. 2008 Aug;21(6):406-8. doi: 10.1097/BSD.0b013e318158971f.

  PMID: 18679094 RESULT

• 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.

  PMID: 12486273 RESULT

• MacVicar J, Borowczyk JM, MacVicar AM, Loughnan BM, Bogduk N. Cervical medial branch radiofrequency neurotomy in New Zealand. Pain Med. 2012 May;13(5):647-54. doi: 10.1111/j.1526-4637.2012.01351.x. Epub 2012 Mar 28.

  PMID: 22458772 RESULT

• Fang L, Tao W, Jingjing L, Nan J. Comparison of High-voltage- with Standard-voltage Pulsed Radiofrequency of Gasserian Ganglion in the Treatment of Idiopathic Trigeminal Neuralgia. Pain Pract. 2015 Sep;15(7):595-603. doi: 10.1111/papr.12227. Epub 2014 Jun 23.

  PMID: 24954016 RESULT

• 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.

  PMID: 16762570 RESULT

• Cohen SP, Peterlin BL, Fulton L, Neely ET, Kurihara C, Gupta A, Mali J, Fu DC, Jacobs MB, Plunkett AR, Verdun AJ, Stojanovic MP, Hanling S, Constantinescu O, White RL, McLean BC, Pasquina PF, Zhao Z. Randomized, double-blind, comparative-effectiveness study comparing pulsed radiofrequency to steroid injections for occipital neuralgia or migraine with occipital nerve tenderness. Pain. 2015 Dec;156(12):2585-2594. doi: 10.1097/j.pain.0000000000000373.

  PMID: 26447705 RESULT

• 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.

  PMID: 20301822 RESULT

• 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.

  PMID: 18055266 RESULT

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After performing patient's eligibility for neck RF and receiving information about procedure, patients will be book for two MBB 4-6 weeks apart. If the patient was eligible after the second MBB, Patient will be asked to sign Informed consent before screening. Screening and recruitment, and randomization, patients will be scheduled for one of the RF techniques.

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 11, 2019
• Study Start: February 10, 2020
• Primary Completion: December 15, 2025
• Study Completion: December 31, 2025
• Last Updated: June 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)