Headache, Occipital Neuralgia
Conditions
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.
Interventions
DEVICERadiofrequency 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.
Sponsors
Allevio Pain Management Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Once eligible, the Redcap will assign the patient to one of the study group. Patients and physician provider will be blinded in the proposed study. Study questionnaires will be completed every three months by patients through RedCap System. Provider physician (here Dr.Rahul Shivaji Pathak) is the person who will perform the procedure.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| At Least of 30% decrease in the pain score | Baseline, every 3 months up to 6 months | measured by Visual Analog Scale (VAS), between minimum of zero and maximum of ten |
| Quality of life assessment | Baseline, every 3 months up to 6 months | measured by Beck's Depression Inventory (BDI) |
| 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) |
Contacts
Primary ContactSHADI BABAZADEH, MD
Outcome results
None listed