Clinical trial NCT04124458: Occipital Nerve RF Between Occipital Nerve Block And Occipital Nerve Radiofrequency Ablation
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Occipital Neuralgia
Headache
Lead sponsor: Allevio Pain Management Clinic
Sponsor class: OTHER
First posted: 2019-10-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Quality of life assessment: Short Form Brief Pain Inventory (BPI-SF)
timeFrame: Change from baseline BPI-SF at 6 months
Secondary outcomes:
measure: At Least of 30% decrease in the pain score
timeFrame: Baseline, every 3 months up to 6 months
measure: At Least of 30% decrease in the pain score
timeFrame: Baseline, every 3 months up to 6 months
measure: Quality of life assessment
timeFrame: Baseline, every 3 months up to 6 months
measure: Quality of life assessment: General Anxiety Disorder Questionnaire (GAD)
timeFrame: Baseline, every 3 months up to 6 months
measure: Quality of life assessment: Patients self-reported perceived duration of effect (PSPDE)
timeFrame: Baseline, every 3 months up to 6 months
measure: Quality of life assessment: Global Improvement and Satisfaction score measured by PGIC)
timeFrame: Baseline, every 3 months up to 6 months
Other outcomes:
Locations:
Study officials:
References:
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