NCT04124458

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Allevio Pain Management Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-02
• Primary completion: 2025-10-31
• Completion: 2025-12-31
• First posted: 2019-10-11
• Last updated: 2022-02-15