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

Allevio Pain Management Clinic

Status: Not yet enrolling

Conditions: Occipital Neuralgia; Headache

Treatments: Device: Radiofrequency ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04124458

16397-11:07:0126-08-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Pulsed Radiofrequency Ablation

Active Comparator group

Description:

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.

Treatment:

Device: Radiofrequency ablation

Bilateral Occipital Nerve Block

Active Comparator group

Description:

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.

Treatment:

Device: Radiofrequency ablation