Post-Traumatic Headache
Conditions
Brief summary
Anesthetic greater occipital nerve (GON) blockade is a simple, inexpensive, and safe procedure that has demonstrable headache pain suppressing effects. In this study, Veterans with post-traumatic headache will be randomized to receive 0.0%, 0.05%, or 0.5% bupivacaine in bilateral GON blocks and the lasting (i.e., transitional) effects on headache frequency measured in a headache diary.
Detailed description
Military Servicemembers are at elevated risk for traumatic brain injury (TBI) and its consequences, including post-traumatic headache (PTH). The most common phenotype of PTH is migraine, for which there are numerous potential treatments, though these have limitations, including poor efficacy, drug-drug interactions, and intolerable side effects. Therefore, the consideration of other methods to manage PTH in Servicemembers and Veterans is warranted. Anesthetic greater occipital nerve (GON) blockade is a simple, inexpensive, and safe procedure that has demonstrable headache pain suppressing effects in a variety of headache disorders. This intervention is frequently done to provide immediate relief, followed by a period of reduced headache burden. In this second portion of this study, Veterans with chronic post-traumatic headache will be randomized to receive 0.0%, 0.05%, or 0.5% bupivacaine in bilateral GON blocks. They will maintain a headache diary to measure the change in headache frequency over the two months after injection. This design uses information gathered from sub-study 1 of this project (NCT#06069791). In that initial intervention, different concentrations of bupivacaine were examined to consider the intensity and spread of acute and subacute sensations that occur with GON blockade. This allowed us to select a low dose (0.05%) that approximates the sensations of the full dose of 0.5%.
Interventions
DRUGBupivacaine bilateral greater occipital nerve block
Three subcutaneous injections of 1 mL each will be injected on both sides of the occipital region around the greater occipital nerve.
Sponsors
Yale University
VA Connecticut Healthcare System
National Headache Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* United States Military Veterans within VA Connecticut Healthcare System1. * Head injury with headaches that have continued to occur for at least three months after the head injury * At least two headache days per week * Review of the medical record does not reveal another source for headache
Exclusion criteria
* Skull defect * Other contraindication to bupivacaine * Allergy or adverse reaction (e.g., rash, cardiac effects) to amide anesthetics, such as lidocaine * Instruction from clinician to avoid amide anesthetics, such as lidocaine * Pregnant or lack of adequate birth control * Clinical review of the patient's case reveals red flag signs or symptoms (e.g., side-locked pain, unilateral numbness/weakness during headache, rapid ascension to peak pain, syncope during attacks) that warrant further work-up (e.g., MRI, arterial imaging). * Absence of imaging warranted by the standard of clinical care for the head injury with headaches.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in headache days/week in the first month | From one month before to one month after injection | Change in the weekly number of headache days after GON blockade |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in headache days/week over two months | From one month before to two months after injection | Change in number of days per week with headache |
| Change in average headache pain intensity | From one month before to two months after injection | Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe) |
| Change in average attack duration | From one month before to two months after injection | Hours |
| Change in average headache-associated light sensitivity | From one month before to two months after injection | Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe) |
| Change in average headache-associated sound sensitivity | From one month before to two months after injection | Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe) |
| Change in average headache-associated nausea/vomiting | From one month before to two months after injection | Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe) |
| Change in average headache-associated functional impairment | From one month before to two months after injection | Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe) |
| Change in average days/week using headache abortive treatment | From one month before to two months after injection | Number of days per week using an abortive treatment for headache |
| Patient Global Impression of Change scale (PGIC) | From one month before to two months after injection | Scale of 1-7 with higher scores indicating worse outcome. |
| Migraine-Specific Quality of Life questionnaire (v2.1) (MSQ) | From one month before to two months after injection | 0-to-100 scale. Higher scores indicate better quality of life. |
| Migraine Disability Assessment (MIDAS) | From one month before to two months after injection | Score from 0 to 270. Higher scores indicating more severe disability. |
| Number of participants with Adverse events | From one month before to two months after injection | Number of participants with Adverse events that occur during or after injection |
Countries
United States
Contacts
CONTACTEmmanuelle Schindler, MD, PhD
PRINCIPAL_INVESTIGATOREmmanuelle Schindler, MD, PhD
VA Connecticut Healthcare System
Outcome results
None listed