Occipital Nerve RF Between Occipital Nerve Block And Occipital Nerve Radiofrequency Ablation
- Conditions
- HeadacheOccipital Neuralgia
- Interventions
- Device: Radiofrequency ablation
- Registration Number
- NCT04124458
- Lead Sponsor
- Allevio Pain Management Clinic
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pulsed Radiofrequency Ablation 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. Bilateral Occipital Nerve Block Radiofrequency ablation 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.
- Primary Outcome Measures
Name Time Method Quality of life assessment: Short Form Brief Pain Inventory (BPI-SF) 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
- Secondary Outcome Measures
Name Time Method Quality of life assessment: General Anxiety Disorder Questionnaire (GAD) Baseline, every 3 months up to 6 months measured by General Anxiety Disorder Questionnaire (GAD)
Quality of life assessment: Patients self-reported perceived duration of effect (PSPDE) Baseline, every 3 months up to 6 months measured by Patients self-reported perceived duration of effect (PSPDE)
Quality of life assessment: Global Improvement and Satisfaction score measured by PGIC) Baseline, every 3 months up to 6 months measured by Global Improvement and Satisfaction score measured by PGIC)
At Least of 30% decrease in the pain score 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
Quality of life assessment Baseline, every 3 months up to 6 months measured by Beck's Depression Inventory (BDI)