Nerve Pain
Conditions
Brief summary
Study an ultrasound guided approach to radiofrequency ablation of the occipital nerve that makes it possible to see the needle during treatment procedure. It is hoped this will reduce the amount of pain after the standard of care procedure.
Interventions
PROCEDUREUltrasound Guided Approach
All enrolled patients will receive the new ultrasound-guided approach to occipital nerve radiofrequency ablation
Sponsors
University of Kansas Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients between the ages of 18-80 with a diagnosis of occipital neuralgia or migraine overlying the occipital region. * A diagnosis of occipital neuralgia will be based on the International Classification of Headache Disorders (ICHD), whose criteria include: paroxysmal stabbing pain in the distribution of the GON, tenderness over the affected nerve, and relief of pain for at least 3 hours after bupivacaine local anesthetic block of the affected nerve. * Patients may also be included if they have a diagnosis of migraine based on the ICHD criteria with predominance of pain over the occipital region that responded to occipital nerve block. * Patients must have failed oral medications including NSAIDs, opioids, and anticonvulsants for the management of their pain. * Failed treatment will be \<50% pain reduction with oral medication. * Patients must report headache frequency of at least 10 days per month.
Exclusion criteria
* Patients will be excluded from the trial if they have an unstable medical or psychological condition, * are pregnant, * have an implanted cardiac pacemaker or defibrillator that could not be disabled, * have had a craniotomy or scar tissue overlying the site from a previous surgery, * have a history of cervical spine fusion, * have evidence of elevated ICP or intracranial tumor, * or have previous RFA treatment of the greater or lesser occipital nerve.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction pain scores reported using an 11-point numeric rating scale (NRS) | 18 Months | Pain scores will be assessed 0-10 at the beginning of the study and at the end. We will compare mean pain scores pre-intervention and post-intervention, and we expect mean pain scores will decrease by 4 points on the NRS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of headache days | 18 months | We will compare frequency of headache days pre-intervention and post-intervention |
| Frequency of moderate-severe headaches | 18 months | We will compare frequency of moderate-severe headaches days pre-intervention and post-intervention |
| Use of acute pain medications | 18 Months | We will compare frequency of Use of acute pain medications pre-intervention and post-intervention |
Countries
United States
Contacts
Primary ContactTimothy Sowder, MD
Backup ContactManuel Clark
Outcome results
None listed