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

Headache Clinical Trial

Official title:

A Comparison of Pain Control AND Quality of Life Improvement Between Occipital Nerve Block And Occipital Nerve Radiofrequency Ablation: A Double-Blind Single Center Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04124458
• Other study ID #: 16397-11:07:0126-08-2019
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2022
• Source: Allevio Pain Management Clinic
• Contact: SHADI BABAZADEH, MD
• Phone: +16474788462
• Email: Shadi.Babazadeh[@]AllevioClinic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

During the first visit the investigator will assess potential subject's eligibility. Screening and recruitment, and randomization, and administer questionnaires will be performed by research coordinator. 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 bilateral Occipital RF or bilateral Occipital Block.

Participants will be asked to complete the follow-up questionnaires at baseline, 3 and 6 months. On their last study visit, participants will have an exit interview, in addition to completing study measures.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Headache
• Neuralgia
• Occipital Neuralgia

Intervention

Device:
• Radiofrequency ablation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allevio Pain Management Clinic

References & Publications (12)

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

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

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 stu — View Citation

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. Review. — View Citation

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, — View Citation

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. — View Citation

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. — View Citation

Inan N, Inan LE, Coskun Ö, Tunç 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. — View Citation

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. eCollection 2016. — View Citation

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. — View Citation

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 — View Citation

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. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At Least of 30% decrease in the pain score	measured by Visual Analog Scale (VAS), between minimum of zero and maximum of ten	Baseline, every 3 months up to 6 months
Secondary	At Least of 30% decrease in the pain score	measured by The Migraine Disability Assessment Test (MIDAS), between minimum of zero and maximum of twenty one	Baseline, every 3 months up to 6 months
Secondary	Quality of life assessment	measured by Beck's Depression Inventory (BDI)	Baseline, every 3 months up to 6 months
Secondary	Quality of life assessment: General Anxiety Disorder Questionnaire (GAD)	measured by General Anxiety Disorder Questionnaire (GAD)	Baseline, every 3 months up to 6 months
Secondary	Quality of life assessment: Patients self-reported perceived duration of effect (PSPDE)	measured by Patients self-reported perceived duration of effect (PSPDE)	Baseline, every 3 months up to 6 months
Secondary	Quality of life assessment: Global Improvement and Satisfaction score measured by PGIC)	measured by Global Improvement and Satisfaction score measured by PGIC)	Baseline, every 3 months up to 6 months