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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Occipital Neuralgia, Headache

Intervention / Treatment
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* Device: Radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulsed Radiofrequency Ablation<br>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<br>* 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.<br>|
| Active Comparator: Bilateral Occipital Nerve Block<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Quality of life assessment | measured by Beck's Depression Inventory (BDI) | Baseline, every 3 months up to 6 months | 
| Quality of life assessment: General Anxiety Disorder Questionnaire (GAD) | measured by 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) | measured by Patients self-reported perceived duration of effect (PSPDE) | Baseline, every 3 months up to 6 months | 
| 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 |