Chiropractic Care for Episodic Migraine

Обзор

Migraine, a chronic intermittent headache disorder, ranks in the top five causes of years lived with disability. One promising non-pharmacologic and integrative treatment for migraine may be chiropractic care due to the co-occurrence of migraine and musculoskeletal complaints. The goal of this application is to perform a pilot study of chiropractic care for episodic migraine to help inform the design of a future, full-scale pragmatic effectiveness trial.

Подробное описание

Migraine, a chronic intermittent headache disorder, ranks in the top five causes for years lived with disability. Due to the high disability burden associated with migraine, individuals who experience migraine often seek treatments to reduce the frequency and severity of their attacks and often express interest in nonpharmacologic and integrative approaches. One promising treatment may be chiropractic care due to the comorbidity of migraine and musculoskeletal complaints.

Our long-term goal is to conduct a multi-site large-scale, fully powered trial evaluating the effectiveness of a validated multimodal chiropractic care intervention to reduce migraine frequency, severity, and disability.

To help inform the design of a large-scale trial with both pragmatic and explanatory features, we propose to conduct a two-arm pilot randomized attention-controlled trial at two sites which are representative of sites to be included in the future large-scale trial. We will recruit and randomize 60 individuals (30 per site) to either 1) 14 visits of chiropractic care (CC) (6 visits of CC over 3-5 weeks followed by 8 visits of CC over 12 weeks); or 2) 14 sessions of headache health education (15-minute 1:1 virtual sessions focused on pre-defined migraine specific topics) - both added to usual medical care. This study will allow us to address the following aims: 1) To train a team of chiropractors from established clinics within two academic medical centers with existing partnerships with headache programs, refine our intervention, and assess the fidelity of intervention protocols; 2) To optimize data collection, data management, and reporting procedures across sites and establish the infrastructure needed for a large-scale trial; 3) To assess the feasibility of recruitment, retention, and adherence across multiple study sites; 4) To assess participant expectations and treatment experience.

Вмешательства

• Процедура Chiropractic Care
  The chiropractic care protocol can be personalized to the patient's clinical needs and follows the scope of chiropractic care practice in the Commonwealth of Massachusetts and the State of Connecticut. Components of the chiropractic intervention include: posture correction / spinal stabilization exercises; soft tissue relaxation techniques; spinal manipulation (i.e. chiropractic adjustment) / mobilization; breathing and relaxation techniques; stretches, self-care; ergonomic modifications; bracin
• Поведенческое Headache Health Education
  Participants randomized to the HHE arm will receive 14 interactive 15-minute education sessions delivered via video conference. To partially control for attention and expectation associated with chiropractic care, participants randomized to the control group will receive a modified version of a headache education intervention we employed in our pilot study. Participants randomized to HHE will receive 14 interactive 15-minute education sessions delivered via VA or MGB Teams. Material to be cover

Первичные конечные точки

• Recruitment feasibility (average number of participants per month) [Срок оценки: 16 months]
• Retention feasibility (proportion of participants not lost to follow-up) [Срок оценки: 20 weeks]
• Intervention adherence feasibility [Срок оценки: 15 weeks]

Вторичные конечные точки (12)

• Number of days with migraine headaches [Срок оценки: Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.]
• Proportion of responders [Срок оценки: Change from baseline to initial follow-up (16 weeks) and change from baseline to final follow-up (20 weeks).]
• Average severity of migraine attacks [Срок оценки: Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.]
• Average number of hours for a migraine attack (duration) [Срок оценки: Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.]
• Average number of medications used for a migraine attack [Срок оценки: Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.]
• Neck Disability Index (NDI) [Срок оценки: Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.]
• Headache Related Disability (HIT-6) [Срок оценки: Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.]
• Migraine Specific Quality of Life Questionnaire, version 2.1 (MSQv2.1) [Срок оценки: Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.]
• Patient-Reported Outcomes Measurement Information System (PROMIS-29) [Срок оценки: Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.]
• PTSD Checklist for DSM-5 (PCL-5) [Срок оценки: Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.]
• Godin Leisure-Time Exercise Questionnaire (GLTEQ) [Срок оценки: Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.]
• The Expectations for Complementary and Alternative Medicine Treatments Questionnaire short form (EXPECT) [Срок оценки: Assess only at baseline following the 4 weeks run-in phase but before randomization.]

Критерии участия

Критерии включения

• Age 18-65 years
• Confirmed diagnosis of migraine with or without aura which does not meet criteria for chronic migraine according to the International Classification for -Headache Disorders (ICHD)-3 guidelines at the screening visit with the study physician
• History of migraines dating for at least one year
• Completion of at least 26 headache diary days out of 28
• Confirmed migraine frequency ≥4 to ≤13 days per month during a run-in period
• If use of medication is applicable, dose must be stable for 2 months prior to study enrollment
• If use of medication for non-migraine pain condition is applicable (with the exception of episodic tension type headache), dose must be stable for 2 months prior to study enrollment
• Willing and able to complete all study procedures and be randomized to either of the two intervention groups
• Fluency in English
• Confirmed access to and proficiency with use of a smartphone, computer, and/or tablet
• Working email address or willingness to create an email account for the study

Критерии исключения

• Non-Veterans (VAMC only)
• Received botulinum toxin treatment for headache and/or neck pain within the 4 months prior to the start of the baseline phase
• Received chiropractic care for any condition within the 3 months prior to the start of the baseline phase
• Received behavioral interventions (e.g., cognitive behavioral therapy, acceptance and commitment therapy, mindfulness, relaxation techniques, hypnosis) within the past 3 months)
• Used neuromodulation (i.e., "headache devices"), procedures for migraine prevention within the 2 months before the baseline period, or investigational medications or headache devices for at least 90 days prior to screening
• Diagnosis of medication overuse headache according to the ICHD-3 guidelines at the screening visit with the study physician
• Traumatic Brain Injury ≤ 1 year before screening visit or worsening of migraine as noted by the screening study physician
• Head or neck trauma within the past year causing neurological or musculoskeletal signs or symptoms requiring treatment
• Any medical, neurologic, or psychiatric condition that the screening study physician deems would lead to difficulty complying with the protocol or negatively impact the safety profile of the interventions
• Psychiatric hospitalization in the last 6 months
• Receiving hospice or palliative care
• History of carotid or vertebral artery dissection
• Presence of carotid bruits
• Presence of contraindications (relative or absolute) for spinal manipulation or mobilization where these procedures cannot be modified for safe administration and are consistent with those published by the World Health Organization (WHO) guidelines, including but not limited to:
• Local spinal hypermobility/instability
• Conditions causing general spinal hypermobility, such as Marfan, Ehlers-Danlos syndrome, and Osteogenesis imperfecta
• Malignancy of the spine or spinal cord
• Frank disc herniation with signs of progressive neurological deficit
• Spinal or intracanalicular hematomas Inflammatory spondyloarthropathies such as rheumatoid arthritis
• Spinal fractures or dislocations
• Avascular necrosis in an area of proposed joint manipulation
• Bone-weakening disorders affecting the spine, such as benign bone tumors, infection, or osteoporosis
• Vertebrobasilar insufficiency syndrome
• Aneurysm involving a major blood vessel in an area of potential joint manipulation
• History of stroke
• Anticoagulant therapy or blood disorders cause significant bleeding tendency
• Cervical spine congenital anomalies that affect the stability or neurologic integrity of the individual or history of cervical spine surgery
• Either self-reported current alcohol or substance use disorder or current alcohol or substance use disorder documented by a treating medical provider within the past 6 months
• Hormone replacement therapy for less than six months, or if prescriptions greater than 6 months in duration must be at a stable dose
• Significant cognitive impairment that would impair participation in the trial
• Currently pregnant or intention to become pregnant within the next six months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Osher Center for Integrative Health, Mass General Brigham — Boston

Публикации

• Albrecht DS, Mainero C, Ichijo E, Ward N, Granziera C, Zurcher NR, Akeju O, Bonnier G, Price J, Hooker JM, Napadow V, Loggia ML, Hadjikhani N. Imaging of neuroinflammation in migraine with aura: A [11C]PBR28 PET/MRI study. Neurology. 2019 Apr 23;92(17):e2038-e2050. doi: 10.1212/WNL.0000000000007371. Epub 2019 Mar 27. PMID 30918090
• Arnold M, Kappeler L, Georgiadis D, Berthet K, Keserue B, Bousser MG, Baumgartner RW. Gender differences in spontaneous cervical artery dissection. Neurology. 2006 Sep 26;67(6):1050-2. doi: 10.1212/01.wnl.0000237341.30854.6a. PMID 17000975
• Ashina S, Bendtsen L, Lyngberg AC, Lipton RB, Hajiyeva N, Jensen R. Prevalence of neck pain in migraine and tension-type headache: a population study. Cephalalgia. 2015 Mar;35(3):211-9. doi: 10.1177/0333102414535110. Epub 2014 May 22. PMID 24853166
• Beaton-Starr M, Rist PM, Connor JP, Wayne PM, Osypiuk K, Bernstein C. Development and Implementation of the Integrative Toolbox for Headache Management. Headache. 2020 Apr;60(4):771-775. doi: 10.1111/head.13743. Epub 2020 Jan 9. PMID 31919834
• Befus DR, Hull S, Strand de Oliveira J, Schmidler GS, Weinberger M, Coeytaux RR. Nonpharmacological Self-Management of Migraine Across Social Locations: An Equity-Oriented, Qualitative Analysis. Glob Adv Health Med. 2019 Jun 13;8:2164956119858034. doi: 10.1177/2164956119858034. eCollection 2019. PMID 31223518
• Bernstein C, Wayne PM, Rist PM, Osypiuk K, Hernandez A, Kowalski M. Integrating Chiropractic Care Into the Treatment of Migraine Headaches in a Tertiary Care Hospital: A Case Series. Glob Adv Health Med. 2019 Mar 28;8:2164956119835778. doi: 10.1177/2164956119835778. eCollection 2019. PMID 30944771
• Connor JP, Bernstein C, Kilgore K, Rist PM, Osypiuk K, Kowalski M, Wayne PM. Perceptions of Chiropractic Care Among Women With Migraine: A Qualitative Substudy Using a Grounded-Theory Framework. J Manipulative Physiol Ther. 2021 Feb;44(2):154-163. doi: 10.1016/j.jmpt.2020.07.001. Epub 2021 Jan 9. PMID 33431279
• Lisi AJ, Brandt CA. Trends in the Use and Characteristics of Chiropractic Services in the Department of Veterans Affairs. J Manipulative Physiol Ther. 2016 Jun;39(5):381-386. doi: 10.1016/j.jmpt.2016.04.005. PMID 27288324

Идентификаторы

NCT: NCT06229834 · 2023P003554 · R01AT012228-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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