Pulsed vs Continuous Radiofrequency Neurotomy for Cervical Facet Joint Mediated Pain

• ClinicalTrials.gov Identifier: NCT04124445
• Recruitment Status: Not yet recruiting
• First Posted: October 11, 2019
• Last Update Posted: October 11, 2019
• Sponsor: Allevio Pain Management Clinic
• Information provided by (Responsible Party): Allevio Pain Management Clinic

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Chronic Cervical Faceto-genic Pain, Including Shoulder Pain and Cervicogenic Headache	Procedure: Pulsed Radiofrequency Ablation	Not Applicable

Detailed Description:

Patients fulfilling eligibility criteria will be randomly allocated to PRF or CRF in a 1:1 ratio. The statistician will use RedCap software to generate random numbers. Patients will be registered to Redcap software and will be concealed from both patients and health care staff. The study coordinator will enter patients' consent and study eligibility information to the Redcap. Once eligible, the Redcap will assign the patient to one of the study group. Patients will be blinded in the proposed study. The assessor is the person who will assess treatment success at the end of the study based on data from completed questionnaires. Questionnaires will be completed every three months by patients through RedCap System. A therapist is the person who will perform the procedure (pain specialist physician). The therapist will not be blinded, because of the nature of intervention.

Patient recruitment is estimated to be completed within 15-24 months. If the required sample size (calculated below) is recruited prior to this time, patient recruitment will be curtailed.

During the first visit the investigator will perform eligibility for neck RF and patient will be received information about the study.

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, and administer questionnaires will be performed by research co-ordinator. Study informed consent form (ICF) can be signed on the RF procedure day. If additional visits will be required to finalize the procedures related to the first visit they will be scheduled accordingly. After randomization the qualified participants will be scheduled for their RF.

For the female subjects between the age of 18-50 a pregnancy test will be asked to obtain on screening visit in order to reduce the risk of pregnancy and potential harm to fetus, unless you had previous tubal ligation, or hysterectomy. Post menopause patients are excluded.

Participants will be asked to complete the follow-up questionnaires at 1, 3, 6, 9, and 12 months.

LANSS questionnaire will be asked to be completed 6 weeks after RF. If the score was 12 or higher, patient will be asked to complete them every 4 weeks after till the score reduce to less than 12. LANSS will be sent to the subjects through RedCap software.

On their last study visit, participants will have an exit interview, in addition to completing study measures.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pulsed vs Continuous Radiofrequency Neurotomy for Cervical Facet Joint Mediated Pain: a Single-blind Randomized Controlled Clinical Trial
• Estimated Study Start Date: December 10, 2019
• Estimated Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: December 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Pulsed Radiofrequency Ablation; 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; 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.; Other Name: Continuous Radiofrequency Ablation
Active Comparator: Continuous Radiofrequency Ablation; 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; 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.; Other Name: Continuous Radiofrequency Ablation

Outcome Measures

Primary Outcome Measures :

1. Quality of life measurement: Visual Analogue Scale [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
   Changes in Visual Analogue Scale (VAS), between minimum of zero and maximum of ten
2. Quality of life measurement: Neck Disability Index [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
   Changes in the Neck Disability Index - AAOS(NDI_AAOS)
3. Quality of life measurement: Short Form Brief Pain Inventory [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
   Changes in the Short Form Brief Pain Inventory (SF-BPI), between minimum of zero and maximum of ten

Secondary Outcome Measures :

1. At least 30% Changes in Pain Score [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
   Proportion of subjects who achieve at least a 30% decrease in the pain score measured by Visual analogue Scale , between minimum of zero and maximum of ten
2. At least 30% Changes in Pain Score [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
   Proportion of subjects who achieve at least a 30% decrease in the pain score measured by Short Form Brief Pain Inventory , between minimum of zero and maximum of ten
3. At least 30% Changes in Pain Score [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
   Proportion of subjects who achieve at least a 30% decrease in the pain score measured by The Neck Disability Index , between minimum of zero and maximum of ten
4. At least 50% Changes in Pain Score [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
   Proportion of subjects who achieve at least a 50% decrease in the pain score measured by The Neck Disability Index
5. At least 50% Changes in Pain Score [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
   Proportion of subjects who achieve at least a 50% decrease in the pain score measured by Short Form Brief Pain Inventory , between minimum of zero and maximum of ten
6. At least 50% Changes in Pain Score [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
   Proportion of subjects who achieve at least a 50% decrease in the pain score measured by Visual analogue Scale , between minimum of zero and maximum of ten
7. Changes in Changes in Global Improvement and Satisfaction [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
   Changes in Global Improvement and Satisfaction score measured by PGIC
8. Changes in The Neck Disability Index [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
   Changes in The Neck Disability Index - AAOS(NDI_AAOS)
9. Changes in General Anxiety Disorder Questionnaire [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
   Changes in General Anxiety Disorder Questionnaire (GAD)
10. Changes in Beck's Depression Inventory [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
    Changes in Beck's Depression Inventory (BDI)
11. Changes in Changes in Patients self-reported perceived duration of effect [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
    Changes in Patients self-reported perceived duration of effect (PSPDE)
12. Adverse events [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
    Safety, assessed by the number, severity and duration of adverse reactions. It will be collected as self-rated health-related complaints by the subject and then confirmed medically. The causality will be assigned by the investigator
13. Pain Medications [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]
    Changes in pain medication use, if it is narcotic, measured by Morphine Equivalent Dose
14. Changes in Leeds assessment of neuropathic symptoms and signs [ Time Frame: 6 weeks after RF and if the score was 12 or higher repeat monthly up to 12 weeks ]
    Changes in the Leeds assessment of neuropathic symptoms and signs (LANSS), between minimum of zero and maximum of twenty four

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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;

Exclusion Criteria:

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);

Contacts and Locations

Locations

Canada, Ontario

Allevio Pain Management Clinic; Not yet recruiting

Toronto, Ontario, Canada, M3B 3S6

Contact: Ramin Safakish, MD. FRCPC 6474788462 Ramin.Safakish@AllevioClinic.com

Contact: Shadi Babazadeh, MD 6474788462 ext Safakish Shadi.Babazadeh@AllevioClinic.com

Principal Investigator: Ramin Safakish, MD. FRCPC

Sub-Investigator: Gil Faclier, MD. FRCPC

Sub-Investigator: Imrat Sohanpal, MD. FRCPC

Sub-Investigator: Rahul Pathak, MD. FRCPC

Sub-Investigator: Nicole Khetani, MD

Sub-Investigator: Praveen Ganty, MD

Sub-Investigator: Ali Mirdamadi, MD

Sub-Investigator: Shadi Babazadeh, MD

Sub-Investigator: Andriy Strilchuk, MD. NP

Sponsors and Collaborators

Allevio Pain Management Clinic

More Information

Publications of Results:

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. Review.

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.

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

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.

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. Review.

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.

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.

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.

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.

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.

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.

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. Epub 2006 Jun 9.

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):2585-94. doi: 10.1097/j.pain.0000000000000373.

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.

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. Epub 2007 Dec 11.

Other Publications:

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

• Responsible Party: Allevio Pain Management Clinic
• ClinicalTrials.gov Identifier: NCT04124445 History of Changes
• Other Study ID Numbers: 16327-16:325610-06-2019
• First Posted: October 11, 2019
• Last Update Posted: October 11, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Results will be published

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Allevio Pain Management Clinic:

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

Additional relevant MeSH terms:

Shoulder Pain; Post-Traumatic Headache; Headache; Pain; Neurologic Manifestations; Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases