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

February 14, 2022 updated by: Allevio Pain Management Clinic

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pulsed 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.
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.
Active Comparator: Bilateral Occipital Nerve Block
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life assessment: Short Form Brief Pain Inventory (BPI-SF)
Time Frame: Change from baseline BPI-SF at 6 months
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
Time Frame: Baseline, every 3 months up to 6 months
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
Time Frame: Baseline, every 3 months up to 6 months
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
Time Frame: Baseline, every 3 months up to 6 months
measured by Beck's Depression Inventory (BDI)
Baseline, every 3 months up to 6 months
Quality of life assessment: General Anxiety Disorder Questionnaire (GAD)
Time Frame: Baseline, every 3 months up to 6 months
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)
Time Frame: Baseline, every 3 months up to 6 months
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)
Time Frame: Baseline, every 3 months up to 6 months
measured by Global Improvement and Satisfaction score measured by PGIC)
Baseline, every 3 months up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allevio Pain Management Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 2, 2023

Primary Completion (Anticipated)

October 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

October 9, 2019

First Submitted That Met QC Criteria

October 10, 2019

First Posted (Actual)

October 11, 2019

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16397-11:07:0126-08-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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