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Treatment of Chronic Migraine and Chronic Tension-Type Headache Treatment of chronic migraine and chronic tension-type headache Draft evidence report February 27, 2017 Health Technology Assessment Program (HTA) Washington State Health Care Authority PO Box 42712 Olympia, WA 98504-2712 (360) 725-5126 www.hca.wa.gov/about-hca/health-technology-assessment [email protected] Treatment of Chronic Migraine and Chronic Tension-Type Headache Provided by: Spectrum Research, Inc. Prepared by: Andrea C. Skelly, PhD, MPH Dena Fischer, DDS, MSD, MS Erika Brodt, BS Cassandra Winter, BS Aaron Ferguson, BS February 28, 2017 With assistance from: Krystle Pagarigan, BS Mark Junge, BS WA – Health Technology Assessment February 28, 2017 This technology assessment report is based on research conducted by a contracted technology assessment center, with updates as contracted by the Washington State Health Care Authority. This report is an independent assessment of the technology question(s) described based on accepted methodological principles. The findings and conclusions contained herein are those of the investigators and authors who are responsible for the content. These findings and conclusions may not necessarily represent the views of the HCA/Agency and thus, no statement in this report shall be construed as an official position or policy of the HCA/Agency. The information in this assessment is intended to assist health care decision makers, clinicians, patients and policy makers in making sound evidence-based decisions that may improve the quality and cost- effectiveness of health care services. Information in this report is not a substitute for sound clinical judgment. Those making decisions regarding the provision of health care services should consider this report in a manner similar to any other medical reference, integrating the information with all other pertinent information to make decisions within the context of individual patient circumstances and resource availability. Treatment of chronic headache: Draft evidence report Page i WA – Health Technology Assessment February 28, 2017 TABLE OF CONTENTS ABBREVIATIONS ......................................................................................................................................... VIII EXECUTIVE SUMMARY ............................................................................................................................... 1-9 1. APPRAISAL ................................................................................................................................................ 1 1.1 BACKGROUND AND RATIONALE ............................................................................................................... 1 1.2 KEY QUESTIONS ................................................................................................................................... 2 1.3 OUTCOMES ASSESSED ........................................................................................................................... 5 1.4 WASHINGTON STATE UTILIZATION AND COST DATA ................................................................................. 15 2. BACKGROUND......................................................................................................................................... 18 2.1. EPIDEMIOLOGY AND BURDEN OF DISEASE ............................................................................................... 18 2.1.1. Headache Classification and Types ................................................................................................. 19 2.1.2. Chronic Migraine ............................................................................................................................. 20 2.1.3. Chronic Tension-Type Headache ..................................................................................................... 22 2.1.4. Chronic Daily Headache, Mixed Headache, Co-existent Migraine and Tension Headache ............. 23 2.2. TECHNOLOGIES/INTERVENTIONS ........................................................................................................... 24 2.2.1. OnabotulinumtoxinA ....................................................................................................................... 24 2.2.2. Acupuncture .................................................................................................................................... 27 2.2.3. Manual Therapies ........................................................................................................................... 28 2.2.4. Massage Therapy ............................................................................................................................ 28 2.2.5. Transcranial Magnetic Stimulation ................................................................................................. 29 2.2.6. Trigger Point Injections ................................................................................................................... 31 2.3. CLINICAL GUIDELINES .......................................................................................................................... 32 2.4. PREVIOUS SYSTEMATIC REVIEW/TECHNOLOGY ASSESSMENTS .................................................................... 37 2.4.1. Previous Health Technology Assessments and Comparative Effectiveness Reviews ...................... 37 2.4.2. AHRQ Report ................................................................................................................................... 37 2.4.3. Previous Systematic Reviews ........................................................................................................... 38 2.5. MEDICARE AND REPRESENTATIVE PRIVATE INSURER COVERAGE POLICIES .................................................... 53 3. THE EVIDENCE ......................................................................................................................................... 60 3.1. METHODS OF THE SYSTEMATIC LITERATURE REVIEW ................................................................................ 60 3.1.1. Objectives ........................................................................................................................................ 60 3.1.2. Key Questions .................................................................................................................................. 60 3.1.3. Inclusion/exclusion criteria .............................................................................................................. 60 3.1.4. Data sources and search strategy ................................................................................................... 65 3.1.5. Data extraction ............................................................................................................................... 67 3.1.6. Quality assessment: Overall Strength of evidence (SoE), Risk of Bias, and QHES evaluation ........ 67 3.1.7. Analysis ........................................................................................................................................... 68 4. RESULTS .................................................................................................................................................. 70 4.1. KEY QUESTION 1: EFFICACY .................................................................................................................. 70 4.1.1. Number of studies retained ............................................................................................................. 70 4.1.2. Chronic Migraine ............................................................................................................................. 71 4.1.2.1. OnabotulinumtoxinA (BoNTA) versus Placebo for Chronic Migraine .............................................. 73 4.1.2.2. OnabotunlinumtoxinA versus Active control for Chronic Migraine ................................................ 85 4.1.2.3. Acupuncture versus Sham for Chronic Migraine ............................................................................. 90 Treatment of chronic headache: Draft evidence report Page ii WA – Health Technology Assessment February 28, 2017 4.1.2.4. Acupuncture versus Active Control for Chronic Migraine................................................................ 90 4.1.2.5. Manual Therapy/Manipulation versus Sham for Chronic Migraine ................................................ 96 4.1.2.6. Manual Therapy/Manipulation versus Active Control for Chronic Migraine .................................. 96 4.1.2.7. Massage versus Sham and versus Active Control for Chronic Migraine ......................................... 99 4.1.2.8. Transcranial Magnetic Stimulation vs. Sham for Chronic Migraine ................................................ 99 4.1.2.9. Transcranial Magnetic Stimulation versus Active Control for Chronic Migraine .......................... 104 4.1.2.10. Trigger Point Injection versus Sham and versus Active Control for Chronic Migraine .................. 104 4.1.3. Chronic Tension-Type Headache ................................................................................................... 104 4.1.3.1. OnabotulinumtoxinA (BoNTA) versus Placebo for Chronic Tension-Type Headache .................... 106 4.1.3.2. OnabotulinumtoxinA versus Active Cotnrol for Chronic Tension-Type Headache ......................... 115 4.1.3.3. Acupuncture versus Sham for Chronic Tension-Type Headache ................................................... 115 4.1.3.4. Acupuncture vs. Active Control for Chronic
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