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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Occipital Neuralgia
- Sponsor
- Allevio Pain Management Clinic
- Enrollment
- 70
- Primary Endpoint
- Quality of life assessment: Short Form Brief Pain Inventory (BPI-SF)
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Quality of life assessment: Short Form Brief Pain Inventory (BPI-SF)
Time Frame: 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 Outcomes
- Quality of life assessment: General Anxiety Disorder Questionnaire (GAD)(Baseline, every 3 months up to 6 months)
- Quality of life assessment: Patients self-reported perceived duration of effect (PSPDE)(Baseline, every 3 months up to 6 months)
- Quality of life assessment: Global Improvement and Satisfaction score measured by PGIC)(Baseline, every 3 months up to 6 months)
- At Least of 30% decrease in the pain score(Baseline, every 3 months up to 6 months)
- Quality of life assessment(Baseline, every 3 months up to 6 months)