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Patient Experience

Validation of practice based evidence for • 54 yo male with a history of refractory increased effective management of after 2004 deployment • Started in 1992 with parachute jump, hard landing, hit head to Chronic and Occipital the left, with Loss of Consciousness (LOC)- 2004- Improvised in the Post 9/11 Combat Veteran explosive Device (IED) blast with LOC • Described as Left hemi-cranial throbbing/aching associated with photophobia/phonophobia, Nausea/Vomiting & worse Karen Williams,MSN, RN, FNP-BC with exertion. Rated as 10/10 Neurology/ Clinic • Occurring 2-4 times per month lasting 3-6 days Central Texas Veterans Health Care System ~ (up to 24 days per month debilitating headache, plus a daily posterior headache)

Overview of the Headache Population Conceptual Framework

• The Headache clinic was established in November 2013 • The Headache Clinic utilizes a • Incorporate multiple modalities: Chronic Care Model • Patient population: • Traditional and Alternative • Medication • Refractory headache patients- most have failed Primary Care • Botox treatments, many have also failed Neurology, all seeking • Occipital blocks alternatives • Acupuncture • Common types of headache- Migraine, Occipital Neuralgia, • Cefaly/Alpha-stim Tension, Cervical degeneration • Relaxation techniques • Common co-occurring diagnosis- prior hx of head and/or neck • Aromatherapy (Peppermint , PTSD, Insomnia, Anxiety/Depression, Musculoskeletal oil) pain, • Patient education (continual)

Study Purpose

• Headache clinic utilizes: o Onabotulinum A (BOTOX) every 12 weeks o Occipital blocks every 4-8 weeks as needed o Treating combat veteran with a history of: • traumatic brain injury(TBI) • neck trauma/whiplash with chronic migraine (CM) • occipital neuralgia o Based on the available evidence /anecdotally this seemed to be very effective o Validation through empirical practice based evidence was needed

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Study Disclaimer Background • This study: • CM in the post 9/11 combat veteran with a history of TBI- is 20% or • Was been reviewed and approved by the Central Texas Veterans more: even after 11 years of treatment (Couch & Stewart 2016; Patil et al., 2011) Health Care System (CTVHCS) Institutional Review Board and University of Alabama at Tuscaloosa • General population CM rate is 4 - 5% (Munakata et al., 2009) • This material is the result of work supported by resources at the • CM causes: reduced work and quality of life, increase in ER and Central Texas Veterans Health Care System primary visits (Munakata et al., 2009) • Does not necessarily express the views of the Department of • Young population: average age of post 9/11 combat with CM 29-30 Veterans Affairs or the United States Government nor does mention years of age (Altalib et al., 2016) of trade names, commercial products, or organizations imply endorsement by the U.S. Government

(Onabotulinumtoxin A “Botox”) Injection Paradigm Knowledge Gap 31 injections into 7 muscle groups • Current treatments- medications for prevention (Topiramate) and Onabotulinum Toxin A (BOTOX)(Yerry, Kuehn, & Finkel, 2015) • Treatments failure- wear off of Botox before 12 weeks and do not fully address the occipital neuralgia • Occipital neuralgia is common after traumatic brain injury (TBI)/neck trauma and may be part of the CM (Ducic, Sinkin, & Crutchfield, 2015; Zaremski, Herman, Clugston, Hurley, & Ahn, 2015) • Occipital Blocks have been an effective treatment for occipital neuralgia and short term relief of CM (Cuadrado et.al, 2016; Gul, Ozon, Karadas, Koc, &; Inan, 2016)

Blumenfeld et. al, Headache 2010;50:1406-1418. 10

Cutaneous innervation of the head and neck

The sensory distribution of the trigeminal nerve (cranial nerve V) and its Occipital three divisions (V1, V2, V3) are show along with Nerve branches of the cervical Anatomy spinal nerves that innervate cutaneous regions of the head and neck.

Image courtesy of UpToDate

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Occipital Block Injection Sites Methodology

• Retrospective review of post 9/11 combat veterans – seen in the headache clinic between Jan 1, 2014- Dec 31, 2015 • History of TBI or neck trauma/whiplash • Findings of CM & Occipital Neuralgia • Treated with Botox and Occipital Blocks • 282 patient charts reviewed > 137 Dx w/CM & Occipital neuralgia > 107 excluded (did not fit all the criteria) > 30 were included GON aiming slightly up maintaining a subcutaneous course LOC aiming lateral and up, maintaining a subcutaneous course Occipital block consisted of 1 to 1 ratio of 1% Lidocaine & 0.5% Bupivacaine, 1 mL into the greater and 0.5 mL into the lesser 13

60% Data Collection 20 • Number of self-reported headache days per month (28 days) 18 18 o The month prior to treatment in the headache clinic 16 o 6 months after treatment in the headache clinic o Mean and 95% confidence interval for # of Headache days/month for pre and post 14 intervention for each subject was computed 12 o Binomial mixed regression model- to determine if the mean # of headache days is 20% significantly lower post intervention 10 17% • Dependent Variables: headache days per month (28 days) 8

• Independent variables: age, gender, head or neck trauma, headache 6 3% types (migraine, tension, occipital neuralgia, medication overuse), 6 4 5 comorbid diseases (mood disorders of anxiety, depression or PTSD, Number of Veterans in each age range musculoskeletal pain, insomnia), prior headache treatments and 2 treatments in the headache clinic of Botox and occipital blocks Veteran ages ranged0 from 27 to 55.4 years of age. [27, 34.1] (34.1, 41.2] (41.2, 48.3] 80% were between the ages of 27 and 41.2 years Patient age

8 PRIOR PREVENTATIVE MEDICATION TREATMENTS

7 Topiramate Divalproex TCA Inderal Verapamil Gabapentin 7

6 6 5 5 23 4 4 9 3 3 3 3

Number ofVeterans 2 2 2 2

1 1 1 1 14 1 19 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2014 Year of Headache Onset Number in the graphic represents the number of veterans who had taken the medication for Headaches started after the head or neck trauma migraine prevention prior to treatment in the headache clinic. 13 veterans had trials of 3 or more medications.

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Comorbid Conditions Gender Distribution of Patients Treated 30

25 25

21 21 20

10 15 Veteran 10

6 20 5 5

0 PTSD Anxiety Depression MSK Insomnia Medical Diagnosis # of Males # of Females Some patients were diagnosed with PTSD & Anxiety or Depression PTSD = Post-traumatic Stress Disorder MSK = Musculoskeletal Disorder

Pre-Post Headache Frequency Results 30

25 • Mean number of headache days in the month prior to treatment was 24.1 (22.0, 25.7)* 20 • Mean number of headache days in the month post-treatment was 12.9 (9.7, 16.4)* 15

• Mean difference in number of headache days (pre-treatment minus 10 post-treatment) was 11.2 (8.2, 14.2)* • Findings were clinically and statistically significant Number of Headache days 5

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Veterans *Numbers in parenthesis are the 95% Confidence Interval Headaches Pre Headaches Post *6 patients did not have a reduction in number of headache days, but did have a reduction in severity of headaches

Limitations/Needs Final Thoughts

• Results are promising in treating CM and Occipital neuralgia with Botox and • Post 9/11 combat veterans, with a history of TBI or neck Occipital Blocks trauma/whiplash with findings of CM and occipital neuralgia, • Limitations: who have not had satisfactory relief of • Inability to have treatment and control group their CM with conventional medical • small sample size (N=30) treatment, may have a reduction in the • self report for only one month pre and post treatment number of days of headache after • Needs: treatment with occipital blocks and Botox • Long term study • In other words: it may reduce the headache • Larger cohort controlled for confounders burden and improve quality of life • Additional studies for CM/Occipital neuralgia treatment in the veteran population

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Karen Williams [email protected]

Central Texas Veterans Health Care System 1901 Veterans Memorial Drive Temple, TX 76504

References References

• Altalib, H. H., Fenton, B. T., Sico, J., Goulet, J. L., Bathulapalli, H., Mohammad, A., . . . • Cuadrado, M. L., Aledo-Serrano, A., Navarro, P., Lopez-Ruiz, P., Fernandez-de-Las-Penas, C., Haskell, S. (2016). Increase in migraine diagnoses and guideline-concordant treatment in Gonzalez-Suarez, I., . . . Fernandez-Perez, C. (2016). Short-term effects of greater occipital veterans, 2004-2012. Cephalalgia: An International Journal of Headache. Advance on nerve blocks in chronic migraine: A double-blind, randomised, placebo-controlled clinical Line Publication. doi:0333102416631959 trial. Cephalalgia : An International Journal of Headache, doi:0333102416655159 • Ducic, I., Sinkin, J. C., & Crutchfield, K. E. (2015). Interdisciplinary treatment of post- • Blumenfeld, A, Silberstein SD, Dodick DW, Aurora SK, Turkel CC, Binder WJ. Method of and post-traumatic headaches. Microsurgery, 35(8), 603-607. doi:10.1002/micr.22503 injection of OnabotulinumtoxinA for chronic migraine: A safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program. Headache: The Journal of • DoD Worldwide Number for TBI. (2016, Aug). Retrieved from http://dvbic.dcoe. mil/files/tbi- Head and Face Pain. 2010;50(9):1406-1418. https://doi.org/10.1111/j.1526- 4610.2010.017 numbers/DoD-TBI-Worldwide-Totals_2000-2016_Feb-17-2017_v1.0_2017-04-06.pdf 66.x. doi: 10.1111/j.1526-4610.2010.01766.x • Finkel, A. G., Yerry, J. A., Klaric, J. S., Ivins, B. J., Scher, A., & Choi, Y. S. (2016). Headache in military service members with a history of mild traumatic brain injury: A cohort study of • Couch, J. R., & Stewart, K. E. (2016). Headache prevalence at 4–11 years after deployment-related diagnosis and classification. Cephalalgia: An International Journal of Headache. Advance traumatic brain injury in veterans of Iraq and Afghanistan wars and comparison to controls: online publication. doi:0333102416651285 A matched case-controlled study. Headache: The Journal of Head and Face Pain, 56(6), • Gul, H. L., Ozon, A. O., Karadas, O., Koc, G., & Inan, L. E. (2016). The efficacy of greater 1004-1021. doi:10.1111/head.12837 occipital nerve blockade in chronic migraine: A placebo-controlled study. Acta Neurologica Scandinavica, n/a. doi:10.1111/ane.12716

References References

• Headache Classification Committee of the International Headache Society, (IHS). (2013). The • Patil, V. K., St. Andre, J. R., Crisan, E., Smith, B. M., Evans, C. T., Steiner, M. L., & Pape, T. L. international classification of headache disorders, 3rd edition (beta version). Cephalalgia : (2011). Prevalence and treatment of headaches in veterans with mild traumatic brain injury. An International Journal of Headache, 33(9), 629-808. doi:10.1177/0333102413485658 Headache: The Journal of Head & Face Pain, 51, 1112-1121. doi:10.1111/j.1526-4610.201 • Management of Concussion-mild Traumatic Brain Injury (mTBI). Retrieved from http://www. 1.01946.x Healthquality.va.gov/guidelines/Rehab/mtbi • Theeler, B. J., & Erickson, J. C. (2009). Mild head trauma and chronic headaches in returning US • Munakata, J., Hazard, E., Serrano, D., Klingman, D., Rupnow, M. F. T., Tierce, J., . . . soldiers. Headache: The Journal of Head and Face Pain, 49, 529-534. doi:10.1111/j.1526-4 Lipton, R. B. (2009). Economic Burden of Transformed Migraine: Results from the 610.2009.01345.x American Migraine Prevalence and Prevention (AMPP) study. Headache: The Journal of • Theeler, B. J., Flynn, F. G., & Erickson, J. C. (2012). Chronic daily headache in U.S. soldiers after Head and Face Pain, 49, 498-508. doi:10.1111/j.1526-4610.2009.01369.x concussion. Headache: The Journal of Head and Face Pain, 52, 732-738. doi:10.1111/j.152 • National Center for Veterans Analysis and Statistics. (2016, May). Profile of Post - 9/11 Veterans: 6-4610.2012.02112.x 2014. Retrieved from http://www.va.gov/vetdata/Veteran_Population.asp • Vos, T., Flaxman, A. D., Naghavi, M., Lozano, R., Michaud, C., Ezzati, M., . . . Atkinson, C. (2013). Years Lived with Disability (YLDs) for 1160 Sequelae of 289 Diseases and 1990-2010: A Systematic Analysis for the Global Burden of Disease Study 2010. Lancet, 380 North American Edition (9859), 2163-2196. doi:10.1016/S0140-6736(12)61729-2

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References

• Yerry, J. A., Kuehn, D., & Finkel, A. G. (2015). Onabotulinum toxin A for the treatment of headache in service members with a history of mild traumatic brain injury: A cohort study. Headache: The Journal of Head & Face Pain, 55, 395-406. doi:10.1111/head.12495 • Zaremski, J. L., Herman, D. C., Clugston, J. R., Hurley, R. W., & Ahn, A. H. (2015). Occipital neuralgia as a sequela of sports concussion: A case series and review of the literature. Current Sports Medicine Reports (American College of Sports Medicine), 14(1), 16-19. doi:10.1249/JSR

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