Chiropractic Care for Episodic Migraine

NCT06229834 | Recruiting DMC

• 2 other identifiers: 2023P003554R01AT012228-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Episodic Migraine

Keywords

migraine; headache disorder

Outcome Measures

Primary Outcomes (3)

• Recruitment feasibility (average number of participants per month)

  Each site will be able to recruit 30 participants within 16 months

  16 months

• Retention feasibility (proportion of participants not lost to follow-up)

  Retention will be quantified by the proportion of subjects who record their migraines for at least 26 out of 28 days and all questionnaires at each outcome assessment.

  20 weeks

• Intervention adherence feasibility

  Adherence will be calculated as the proportion of subjects who attend at least 80% of the chiropractic care visits or 80% of the one-on-one headache health education video-conferences.

  15 weeks

Secondary Outcomes (12)

• Number of days with migraine headaches

  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

  Change from baseline to initial follow-up (16 weeks) and change from baseline to final follow-up (20 weeks).

• Average severity of migraine attacks

  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)

  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

  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.

Study Arms (2)

Chiropractic Care

EXPERIMENTAL

4 sessions of chiropractic care (6 sessions of chiropractic care over 3-5 weeks followed by 8 sessions of chiropractic care over 12 weeks); participants will be allowed to continue usual care throughout the study.

Procedure: Chiropractic Care

Headache Health Education (HHE)

OTHER

Participants randomized to Headache Health Education (HHE) will receive 14 interactive 15-minute education sessions delivered via videoconference.

Behavioral: Headache Health Education

Interventions

Chiropractic Care PROCEDURE

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; bracing and supports.

Chiropractic Care

Headache Health Education BEHAVIORAL

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 covered will focus on pre-defined migraine-specific topics, compared with the control for our pilot study, in addition to greater contact time, HHE will be delivered in a more interactive manner utilizing active learning principles known to support adult learning. We will also utilize publicly available short videos (e.g., from the American Headache Society) followed by scripted discussions with the participant. Example topics include the physiology of migraine or the contribution of life.

Headache Health Education (HHE)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Palmer College of Chiropractic: collaborator
• Yale University: collaborator
• VA Connecticut Healthcare System: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Osher Center for Integrative Health, Mass General Brigham

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (15)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Rist PM, Bernstein C, Kowalski M, Osypiuk K, Connor JP, Vining R, Long CR, Macklin EA, Wayne PM. Multimodal chiropractic care for migraine: A pilot randomized controlled trial. Cephalalgia. 2021 Mar;41(3):318-328. doi: 10.1177/0333102420963844. Epub 2020 Oct 13.

  PMID: 33050719 BACKGROUND

• Rist PM, Buring JE, Ridker PM, Kase CS, Kurth T, Rexrode KM. Lipid levels and the risk of hemorrhagic stroke among women. Neurology. 2019 May 7;92(19):e2286-e2294. doi: 10.1212/WNL.0000000000007454. Epub 2019 Apr 10.

  PMID: 30971484 BACKGROUND

• Rist PM, Hernandez A, Bernstein C, Kowalski M, Osypiuk K, Vining R, Long CR, Goertz C, Song R, Wayne PM. The Impact of Spinal Manipulation on Migraine Pain and Disability: A Systematic Review and Meta-Analysis. Headache. 2019 Apr;59(4):532-542. doi: 10.1111/head.13501. Epub 2019 Mar 14.

  PMID: 30973196 BACKGROUND

• Wayne PM, Bernstein C, Kowalski M, Connor JP, Osypiuk K, Long CR, Vining R, Macklin E, Rist PM. The Integrative Migraine Pain Alleviation through Chiropractic Therapy (IMPACT) trial: Study rationale, design and intervention validation. Contemp Clin Trials Commun. 2020 Jan 22;17:100531. doi: 10.1016/j.conctc.2020.100531. eCollection 2020 Mar.

  PMID: 32043014 BACKGROUND

• Wayne PM, Buring JE, Davis RB, Connors EM, Bonato P, Patritti B, Fischer M, Yeh GY, Cohen CJ, Carroll D, Kiel DP. Tai Chi for osteopenic women: design and rationale of a pragmatic randomized controlled trial. BMC Musculoskelet Disord. 2010 Mar 1;11:40. doi: 10.1186/1471-2474-11-40.

  PMID: 20193083 BACKGROUND

• Wayne PM, Gagnon MM, Macklin EA, Travison TG, Manor B, Lachman M, Thomas CP, Lipsitz LA. The Mind Body-Wellness in Supportive Housing (Mi-WiSH) study: Design and rationale of a cluster randomized controlled trial of Tai Chi in senior housing. Contemp Clin Trials. 2017 Sep;60:96-104. doi: 10.1016/j.cct.2017.07.005. Epub 2017 Jul 8.

  PMID: 28694204 BACKGROUND

• Wayne PM, Manor B, Novak V, Costa MD, Hausdorff JM, Goldberger AL, Ahn AC, Yeh GY, Peng CK, Lough M, Davis RB, Quilty MT, Lipsitz LA. A systems biology approach to studying Tai Chi, physiological complexity and healthy aging: design and rationale of a pragmatic randomized controlled trial. Contemp Clin Trials. 2013 Jan;34(1):21-34. doi: 10.1016/j.cct.2012.09.006. Epub 2012 Sep 29.

  PMID: 23026349 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Headache Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Pamela M Rist, ScD

CONTACT

617-278-0835; prist@mail.harvard.edu

Viviane Nguyen, BS

CONTACT

617-525-9836; Vnguyen11@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: While participants, treating chiropractors, study coordinators, and research assistants will be unblinded to treatment assignment, study investigators who are not involved in providing chiropractic care treatments or monitoring adverse events will be blinded. The blinding of these investigators and the programmer will only be broken after approval of the final statistical analysis plan and locking of the trial data.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: 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 (Osher Clinic, BWH, and VA Medical Center, West Haven, CT). We will recruit and randomize 60 individuals (30 per site). Individuals will be randomized (1:1) to: 1) 14 sessions of CC (6 sessions of chiropractic care over 3-5 weeks followed by 8 sessions of chiropractic care (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. Individuals will be followed for 4 weeks after the end of their intervention period.

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 29, 2024
• Study Start: March 22, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)