Imaging of neuroinflammation in migraine with aura: A [11C]PBR28 PET/MRI study.
Daniel S Albrecht, Caterina Mainero, Eri Ichijo...
https://pubmed.ncbi.nlm.nih.gov/30918090Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06229834
Chiropractic Care for Episodic Migraine
Led by Brigham and Women's Hospital · Updated on 2025-07-09
60
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
P
Palmer College of Chiropractic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Migraine is a chronic intermittent headache disorder that ranks among the top five causes of years lived with disability. Many people with migraines are interested in non-drug and integrative treatments to reduce how often and how severely they experience attacks. This research aims to study chiropractic care as a possible treatment option for episodic migraine, helping to prepare for a larger future trial that will fully evaluate this approach. The study is a pilot randomized trial with two groups. One group will receive 14 chiropractic care sessions, starting with 6 visits over 3-5 weeks followed by 8 visits over 12 weeks. The chiropractic care includes posture correction exercises, spinal manipulation, soft tissue relaxation, breathing and relaxation techniques, stretches, ergonomic advice, and supports. The other group will receive 14 interactive 15-minute headache health education sessions via video conference. Both groups will continue their usual medical care throughout the study. Participants will be involved for about 24 weeks, including baseline and follow-up periods. Researchers will collect data on migraine frequency, severity, duration, medication use, disability, quality of life, and exercise habits. They will also assess recruitment and retention rates, adherence to treatments, and participant expectations. The study includes various questionnaires and diaries to monitor these outcomes, supporting the development of a larger trial in the future.
CONDITIONS
Brief Title
Chiropractic Care for Episodic Migraine
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18-65 years
- Confirmed diagnosis of migraine with or without aura not meeting criteria for chronic migraine
- History of migraines for at least one year
- Completed at least 26 headache diary days out of 28
- Migraine frequency of 4 to 13 days per month during run-in period
- Stable medication dose for migraine or non-migraine pain conditions for at least 2 months prior
- Willing and able to complete all study procedures and be randomized
- Fluent in English
- Access to and ability to use a smartphone, computer, or tablet
- Has or willing to create a working email address
You will not qualify if you...
- Not a Veteran (VAMC only)
- Received botulinum toxin treatment for headache or neck pain within 4 months before baseline
- Received chiropractic care within 3 months before baseline
- Received behavioral interventions for headache within past 3 months
- Used neuromodulation or investigational headache medications/devices within 2-3 months before screening
- Diagnosis of medication overuse headache
- Traumatic brain injury within 1 year before screening or worsening migraine
- Head or neck trauma within past year causing neurological or musculoskeletal symptoms requiring treatment
- Medical, neurologic, or psychiatric conditions that interfere with study participation or safety
- Psychiatric hospitalization within last 6 months
- Receiving hospice or palliative care
- History of carotid or vertebral artery dissection
- Presence of carotid bruits
- Contraindications for spinal manipulation or mobilization (e.g., spinal instability, malignancy, fractures, hematomas, inflammatory arthritis, bone-weakening disorders)
- Vertebrobasilar insufficiency syndrome
- Aneurysm involving major blood vessel in manipulation area
- History of stroke
- On anticoagulant therapy or with bleeding disorders
- Cervical spine congenital anomalies or prior cervical spine surgery
- Current alcohol or substance use disorder within past 6 months
- Hormone replacement therapy less than 6 months or unstable dose
- Significant cognitive impairment
- Currently pregnant or planning pregnancy within 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - 4 weeks
Participants complete a 4-week run-in phase during which baseline migraine frequency and severity are recorded before randomization.
Diary entries completed daily
Treatment
Duration - Approximately 15 weeks
Participants are randomized to receive either chiropractic care consisting of 14 visits over approximately 15 weeks or 14 interactive 15-minute headache health education sessions delivered via videoconference, both in addition to usual medical care.
14 visits for chiropractic care or 14 virtual education sessions
Follow-up
Duration - Up to 5 weeks
Participants are monitored for retention, adherence, and migraine outcomes for up to 5 weeks after treatment completion.
Follow-up assessments during scheduled visits
Trial Site Locations
Total: 1 location
1
Osher Center for Integrative Health, Mass General Brigham
Boston, Massachusetts, United States, 02215
Actively Recruiting
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Research Team
P
Pamela M Rist, ScD
V
Viviane Nguyen, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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