Occipital Nerve RF Between Occipital Nerve Block And Occipital Nerve Radiofrequency Ablation

NCT04124458 | Unknown DMC

• 1 other identifier: 16397-11:07:0126-08-2019
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, double blind, single-center, clinical trial. The study will be conducted over a period of 6 months. The study will be conducted at the Allevio Pain Clinic, Toronto, Canada.

Conditions

Occipital Neuralgia; Headache

Outcome Measures

Primary Outcomes (1)

• Quality of life assessment: Short Form Brief Pain Inventory (BPI-SF)

  measured by Short Form Brief Pain Inventory (BPI-SF), between minimum of zero and maximum of ten

  Change from baseline BPI-SF at 6 months

Secondary Outcomes (6)

• At Least of 30% decrease in the pain score

  Baseline, every 3 months up to 6 months

• At Least of 30% decrease in the pain score

  Baseline, every 3 months up to 6 months

• Quality of life assessment

  Baseline, every 3 months up to 6 months

• Quality of life assessment: General Anxiety Disorder Questionnaire (GAD)

  Baseline, every 3 months up to 6 months

• Quality of life assessment: Patients self-reported perceived duration of effect (PSPDE)

  Baseline, every 3 months up to 6 months

Study Arms (2)

Pulsed Radiofrequency Ablation

ACTIVE COMPARATOR

In radiofrequency ablation arm, sensory brunch of occipital nerve will be burn with max allowable temperature: 42 degrees Celsius, real temperature: 41 degrees Celsius, power=65 volts, two cycles of 180 second.

Device: Radiofrequency ablation

Bilateral Occipital Nerve Block

ACTIVE COMPARATOR

In this arm all steps are the same as other arm, except the generator will not be on and patient will have pain relief by injecting numbing medications beside the sensory nerves.

Device: Radiofrequency ablation

Interventions

Radiofrequency ablation DEVICE

In radiofrequency ablation arm, sensory brunch of occipital nerve will be burn with max allowable temperature: 42 degrees Celsius, real temperature: 41 degrees Celsius, power=65 volts, two cycles of 180 second.

Bilateral Occipital Nerve Block; 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
• Confirmed diagnosis of occipital headaches, patients with concurrent other types of headaches will not be excluded (except undiagnosed headaches)
• Duration of occipital headaches \> 3 months

You may not qualify if:

• Non-English speakers;
• Refusal to sign informed consent;
• Allergy to medications which will be used in the study;
• Concurrent undiagnosed headaches
• Current brain tumors
• Current known tumors with known metastasis in other organs
• Occipital blocks within the last 3 months
• Currently receiving treatment with Botox for migraine.
• Patient has RF of occipital nerve/s within the last year

Sponsors & Collaborators

• Allevio Pain Management Clinic: lead

Related Publications (12)

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

  BACKGROUND

• Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.

  PMID: 23771276 RESULT

• Steiner TJ, Paemeleire K, Jensen R, Valade D, Savi L, Lainez MJ, Diener HC, Martelletti P, Couturier EG; European Headache Federation; Lifting The Burden: The Global Campaign to Reduce the Burden of Headache Worldwide; World Health Organization. European principles of management of common headache disorders in primary care. J Headache Pain. 2007 Oct;8 Suppl 1:S3-47. doi: 10.1007/s10194-007-0366-y. No abstract available.

  PMID: 18034215 RESULT

• Stovner Lj, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, Steiner T, Zwart JA. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007 Mar;27(3):193-210. doi: 10.1111/j.1468-2982.2007.01288.x.

  PMID: 17381554 RESULT

• Ducic I, Felder JM 3rd, Fantus SA. A systematic review of peripheral nerve interventional treatments for chronic headaches. Ann Plast Surg. 2014 Apr;72(4):439-45. doi: 10.1097/SAP.0000000000000063.

  PMID: 24374395 RESULT

• Inan N, Inan LE, Coskun O, Tunc T, Ilhan M. Effectiveness of Greater Occipital Nerve Blocks in Migraine Prophylaxis. Noro Psikiyatr Ars. 2016 Mar;53(1):45-48. doi: 10.5152/npa.2015.10003. Epub 2016 Mar 1.

  PMID: 28360765 RESULT

• Okmen K, Dagistan Y, Dagistan E, Kaplan N, Cancan E. Efficacy of the greater occipital nerve block in recurrent migraine type headaches. Neurol Neurochir Pol. 2016;50(3):151-4. doi: 10.1016/j.pjnns.2016.01.015. Epub 2016 Feb 6.

  PMID: 27154440 RESULT

• Hascalovici JR, Robbins MS. Peripheral Nerve Blocks for the Treatment of Headache in Older Adults: A Retrospective Study. Headache. 2017 Jan;57(1):80-86. doi: 10.1111/head.12992. Epub 2016 Nov 30.

  PMID: 27901275 RESULT

• Kim DD, Sibai N. Prolongation of greater occipital neural blockade with 10% lidocaine neurolysis: a case series of a new technique. J Pain Res. 2016 Sep 29;9:721-725. doi: 10.2147/JPR.S112947. eCollection 2016.

  PMID: 27729811 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

• 11. Cervicogenic headache in Headache and Migraine Biology and Management 2015, Pages 203-212. Cooper W, Masih A.

  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

Headache

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

SHADI BABAZADEH, MD

CONTACT

+16474788462; Shadi.Babazadeh@AllevioClinic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Once eligible, the Redcap will assign the patient to one of the study group. Patients and physician provider will be blinded in the proposed study. Study questionnaires will be completed every three months by patients through RedCap System. Provider physician (here Dr.Rahul Shivaji Pathak) is the person who will perform the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, double blind, single-center, clinical trial. Participants will be randomly allocated to P-RF or occipital block intervention groups in a 1:1 ratio using a computer-generated algorithm. The study will be conducted over a period of 6 months, during which patients will make 4 visits (screening, baseline visit (Day 0) and 3, 6 months follow up visits, with ±1-week window). The study will be conducted at the Allevio Pain Clinic, Toronto, Canada. Research Ethics approvals will be sought.

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 11, 2019
• Study Start: January 2, 2023
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 15, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share