The Definition of Intractable Headache

Educational Objectives

The goal of this program is to improve the management of intractable headaches. After hearing and assimilating this program, the clinician will be better able to:

1. Explain the importance of defining refractory or intractable headaches in patients with chronic headache.
2. Identify and treat patients with refractory or intractable headaches.

Summary

Definitions: intractable — “not easily relieved or cured”; may never improve; never-ending, daily, continuous; refractory — “resistant to a process or stimulus”; not yielding to treatment; lack of treatment response; failure to respond to or inability to tolerate current evidence-based treatments

Aspects of definition: severity — moderate to severe headache daily vs mild headaches daily; response to medications — multiple medications ineffective or not tolerated; ineffectiveness of acute vs preventive medicines; disability — daily, mild tension-type headache without disability vs daily moderate to severe headache with disability 7 to 8 days per mo; medication overuse — can reduce effectiveness of preventive medication; question whether patients should be considered as having intractable headache or should stop overusing medications before headache defined; frequency — severe episodic migraine 10 to 12 days per mo with no effective acute medication vs daily continuous headache

Criteria: 2 most important criteria for defining population with intractable headache are response to medication and disability

Importance of defining populations: population with chronic migraine (CM) that responds well to treatment different population than those with CM that cannot tolerate standard of care and may need more aggressive therapy; thus, definition important to both patients and treating clinicians; importance to research — desirable to know number of patients with intractable headache and how to identify appropriate patients for studies

Patient populations: CM/chronic cluster — high-disability group; high-frequency episodic migraine — several headaches per mo; disability level can be almost equal to CM; lack of response to medication can raise disability level further, affecting quality of life (QOL); may qualify as refractory group

Disability: headaches must significantly interfere with function or QOL; intractable or refractory headache (RH) must have effects besides disease itself (eg, missing life events); patients must have attempted therapies other than medications, such as lifestyle modification and trigger management, before being considered refractory to treatment; optimize mood disorders, sleep dysfunction, and improve management of stress and weight; eliminate modifiable triggers

Failure of treatment: allow ≈3 mo for medication to work; adequate trial indicates medication ineffective or causing significant side effects or dysfunction; for migraine headaches, failure of 2 to 4 medications in different categories considered adequate trial; for cluster headache, 4 preventive medications must be failed to be considered refractory; general consensus holds that patient with migraine should have tried at least triptan and ergotamine as abortive medications, and NSAID or combination analgesic, before being considered refractory

Medication overuse: in United States, patients with overuse who may have attempted to withdraw may be considered to have RH; in Europe, patients must undergo detoxification before considered to have RH; anxiety — increases with number of headaches; some overlap between pathophysiology of migraine and of anxiety and depression; more pain increases disability and anxiety about pain; more so than cluster headaches, migraines can occur at any time, which also increases anxiety, leading to overuse of medication; important to manage patient’s anxiety before diagnosing RH; management ideally involves behavioral therapy in addition to medications

American Headache Society (AHS): surveys — 91% of members said refractory migraine needed definition, and 87% said nonmigraine RH did as well; 86% said these should be added to International Classification of Headache Disorders; >78% wanted “inadequate response to multiple abortive and preventive medications” included in definition; 63% would limit RH to headaches >50% of mo (would not include episodic disease); >50% said disability should be addressed; diagnostic criteria for refractory migraine — not included in international criteria, but reflect current practice; features in AHS definition — failed adequate trials of medications in ≥2 of 4 drugs classes; tried adequate trials of abortive medication; adequate trial consists of ≥2 mo of optimal or maximum tolerated dose unless terminated early because of adverse effects; includes medication overuse; includes Migraine Disability Assessment (MIDAS) score; looks at disability over past 3 mo (eg, missed work) and QOL measures

European Headache Federation; definition of refractory CM includes failure of 3 preventive medications at specific doses and notes importance of treating psychiatric or other comorbidities; medication overuse excluded; requires that secondary headaches ruled out and patients have extensive workup; efficacy of drug defined as >50% reduction of headache days; defines refractory cluster headache by appropriate dose, length of time, and failure of ≥4 drug classes; severity of RH classified by failure of increasing number of drugs from both abortive and preventive classes

Studies: 5.1% of consecutive patients seen at headache center had refractory (R) CM; most were women; some had medication overuse; most had CM; RCM with medication overuse had higher rate of disability than RCM without medication overuse; rating scale study — point system assigned to patients with RCM; scale divided into mild, moderate, and severe; patients followed for 10 yr; study showed patients generally improved over 10 yr in all categories, including pain and QOL; however, less improvement seen in patients in severe group

Readings

Irimia P et al: Refractory migraine in a headache clinic population. BMC Neurol 2011 Aug 1;11:94; Lipton RB et al: OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine over one year of treatment: Pooled results from the PREEMPT randomized clinical trial program. Cephalalgia 2016 Aug;36(9):899-908; Martelletti P et al: Refractory chronic migraine: a consensus statement on clinical definition from the European Headache Federation J Headache Pain. 2014 Aug 28;15:47; Robbins L: Refractory chronic migraine: long-term follow-up using a refractory rating scale. J Headache Pain 2012 Apr;13(3):225-9; Schulman EA, Brahin EJ et al: Refractory headache: historical perspective, need, and purposes for an operational definition. Headache 2008 Jun;48(6):770-7; Silberstein SD et al: Defining the pharmacologically intractable headache for clinical trials and clinical practice. Headache 2010 Oct;50(9):1499-506.

Disclosures

For this program, the following has been disclosed: Dr. Ailani is on the Speakers’ Bureau for Allergan, Avanir, and Eli Lilly and Co. and is on the advisory panel for Eli Lilly and Co. In her lecture, Dr. Ailani presents information that is related to the off-label or investigational use of a therapy, product, or device.

Acknowledgements

Dr. Ailani was recorded at Headache Update 2017, held July 13-16, 2017 in Lake Buena Vista, FL, and presented by Diamond Headache Clinic Research and Educational Foundation, Presence Saint Joseph Hospital, and Primary Care Network. For information on upcoming CME programs from Diamond Headache Clinic Research and Educational Foundation, Presence Saint Joseph Hospital, and Primary Care Network, please visit dhc-fdn.org. The Audio Digest Foundation thanks Dr. Ailani and the sponsors for their cooperation in the production of this program.

CME/CE INFO

Accreditation:

The Audio- Digest Foundation is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The Audio- Digest Foundation designates this enduring material for a maximum of 0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Audio Digest Foundation is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's (ANCC's) Commission on Accreditation. Audio Digest Foundation designates this activity for 0 CE contact hours.

Lecture ID:

NE090802

Expiration:

This CME course qualifies for AMA PRA Category 1 Credits™ for 3 years from the date of publication.

Instructions:

To earn CME/CE credit for this course, you must complete all the following components in the order recommended: (1) Review introductory course content, including Educational Objectives and Faculty/Planner Disclosures; (2) Listen to the audio program and review accompanying learning materials; (3) Complete posttest (only after completing Step 2) and earn a passing score of at least 80%. Taking the course Pretest and completing the Evaluation Survey are strongly recommended (but not mandatory) components of completing this CME/CE course.

Estimated time to complete this CME/CE course:

Approximately 2x the length of the recorded lecture to account for time spent studying accompanying learning materials and completing tests.