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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
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.
Quality of life assessment: Short Form Brief Pain Inventory (BPI-SF)
measured by Short Form Brief Pain Inventory (BPI-SF), between minimum of zero and maximum of ten
Time frame: Change from baseline BPI-SF at 6 months
At Least of 30% decrease in the pain score
measured by Visual Analog Scale (VAS), between minimum of zero and maximum of ten
Time frame: Baseline, every 3 months up to 6 months
At Least of 30% decrease in the pain score
measured by The Migraine Disability Assessment Test (MIDAS), between minimum of zero and maximum of twenty one
Time frame: Baseline, every 3 months up to 6 months
Quality of life assessment
measured by Beck's Depression Inventory (BDI)
Time frame: Baseline, every 3 months up to 6 months
Quality of life assessment: General Anxiety Disorder Questionnaire (GAD)
measured by General Anxiety Disorder Questionnaire (GAD)
Time frame: Baseline, every 3 months up to 6 months
Quality of life assessment: Patients self-reported perceived duration of effect (PSPDE)
measured by Patients self-reported perceived duration of effect (PSPDE)
Time frame: Baseline, every 3 months up to 6 months
Quality of life assessment: Global Improvement and Satisfaction score measured by PGIC)
measured by Global Improvement and Satisfaction score measured by PGIC)
Time frame: Baseline, every 3 months up to 6 months
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