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

NCT ID: NCT04124458

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-02
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Occipital Neuralgia; Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Radiofrequency ablation

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Radiofrequency ablation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allevio Pain Management Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

SHADI BABAZADEH, MD

Role: CONTACT

Shadi.Babazadeh@AllevioClinic.com

+16474788462

References

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Reference Type: BACKGROUND

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Other Identifiers

16397-11:07:0126-08-2019

Identifier Type: -

Identifier Source: org_study_id