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

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.

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.

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.

Once eligible, the Redcap will assign the patient to one of the study group. Patients and physician provider will be blinded in the proposed study. Study questionnaires will be completed every three months by patients through RedCap System. Provider physician (here Dr.Rahul Shivaji Pathak) is the person who will perform the procedure.

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.

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.

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.

measured by The Migraine Disability Assessment Test (MIDAS), between minimum of zero and maximum of twenty one

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

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