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Episodic MigraineNCT06229834

Chiropractic Care for Episodic Migraine

A study testing Chiropractic Care and Headache Health Education in people with Episodic Migraine, run by Brigham and Women's Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Episodic Migraine
What is being tested?
Chiropractic Care and Headache Health Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
22 Mar 2025to 30 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 31Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pamela M Rist, ScD contact

617-278-0835

prist@mail.harvard.edu

Viviane Nguyen, BS contact

617-525-9836

Vnguyen11@bwh.harvard.edu

United States1 site, 1 recruiting

  • Osher Center for Integrative Health, Mass General Brigham

    Boston, Massachusetts, 02215

    Viviane Nguyen, BS, 617-525-9836, vnguyen11@bwh.harvard.edu

    Peter Wayne, PhD, 617-732-6271, pwayne@bwh.harvard.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Chiropractic Care, Headache Health Education
Keywords
migraine, headache disorder
Medical subject headings
Migraine Disorders, Headache Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chiropractic CareProcedure or surgery

    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.

  • Headache Health EducationBehavioural

    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.

Study groups in NCT06229834
Study groupRoleWhat they receive
Chiropractic CareExperimental4 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.
Receives: Procedure: Chiropractic Care
Headache Health Education (HHE)OtherParticipants randomized to Headache Health Education (HHE) will receive 14 interactive 15-minute education sessions delivered via videoconference.
Receives: Behavioral: Headache Health Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment feasibility (average number of participants per month)

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

    Measured: 16 months

  2. 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.

    Measured: 20 weeks

  3. 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.

    Measured: 15 weeks

Secondary outcomes (12)

  1. Number of days with migraine headaches

    Number of migraine headaches as recorded in migraine diaries.

    Measured: 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.

  2. Proportion of responders

    Proportion of individuals who experience a ≥50% reduction in migraine days.

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

  3. Average severity of migraine attacks

    Average severity of migraine attacks (on a 1 to 10 scale) as recorded in migraine diaries.

    Measured: 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.

  4. Average number of hours for a migraine attack (duration)

    Average number of hours a migraine attack lasted as recorded in migraine diaries.

    Measured: 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.

  5. Average number of medications used for a migraine attack

    Average number of medications used to treat a migraine attack as recorded in migraine diaries

    Measured: 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.

  6. Neck Disability Index (NDI)

    Self-report questionnaire used to determine how neck pain impacts daily activities of living and self-related neck pain disability.

    Score range: 10 - 60. Higher scores indicate greater disability.

    Measured: 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.

  7. Headache Related Disability (HIT-6)

    HIT-6 is a validated 6-item assessment that evaluates the impact headaches have on a participant's life. Score range: 36 - 78. Higher scores indicate greater disability.

    Measured: 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.

  8. Migraine Specific Quality of Life Questionnaire, version 2.1 (MSQv2.1)

    Migraine Specific Quality of Life Questionnaire, version 2.1 (MSQv2.1) is a validated 14-item questionnaire; it is one of the most frequently used disability instrument in migraine research and is highly reliable.

    Participants are asked to provide their response to each question using a standard six point Likert-type scale (none of the time; a little bit of the time; some of the time; a good bit of the time; most of the time; all of the time). Each MSQoL v.2.1 dimension is scored independently from 0 to 100 such that a higher score indicates a better quality of life.

    Measured: 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.

  9. Patient-Reported Outcomes Measurement Information System (PROMIS-29)

    PROMIS-29 is a system of validated, highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being.

    PROMIS-29 v2. 0 profile measure assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items for each domain.The patients' answers to the PROMIS-29 are scored from 1-5 (with the exception of the NRS). The sum of the PROMIS results in the raw score, which lies between 4 and 20. There is no total score, but each axis forms its own score.

    Measured: 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.

  10. PTSD Checklist for DSM-5 (PCL-5)

    20-item self-report measure of the DSM-5 symptoms of PTSD. Score range: 0 - 5. Higher scores are associated with greater likelihood of PTSD.

    Measured: 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.

  11. Godin Leisure-Time Exercise Questionnaire (GLTEQ)

    Godin Leisure-Time Exercise Questionnaire will be used to measure the amount and intensity of general exercise during the study period. This validated instrument consists of 4 items measuring the frequency of light, moderate, and vigorous-intensity leisure-time physical activity. In the GLTEQ, individuals are asked to complete a self-explanatory, brief four-item query of usual leisure-time exercise habits.

    Higher score indicate more leisure-time exercise per week.

    Measured: 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.

  12. The Expectations for Complementary and Alternative Medicine Treatments Questionnaire short form (EXPECT)

    EXPECT Questionnaire (short form) is a recently developed and validated questionnaire used to assess individuals' expectations of treatments for chronic pain.

    Score range: 0 - 40. Higher scores indicate higher expectation of recovery after treatment.

    Measured: Assess only at baseline following the 4 weeks run-in phase but before randomization.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2024
  2. Study start22 Mar 2025
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06229834
Sponsor's protocol ID
2023P003554
Other IDs
R01AT012228-01
Status last verified
Jun 2026
First submitted
12 Jan 2024
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Investigators interested in using data from this trial will be directed to contact the multiple principle investigators for data access.

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 27288324

  • 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.

    PubMed 33050719

  • 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.

    PubMed 30971484

  • 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.

    PubMed 30973196

  • 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.

    PubMed 32043014

  • 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.

    PubMed 20193083

  • 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.

    PubMed 28694204

  • 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.

    PubMed 23026349

Questions about this trial

What is this clinical trial studying?

A study testing Chiropractic Care and Headache Health Education in people with Episodic Migraine, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pamela M Rist, ScD (617-278-0835, prist@mail.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment feasibility (average number of participants per month) (time frame: 16 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06229834, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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