Exploring the Mechanism of Osteopathic Manual Therapy (OMT) on Brain Structure and Function in Primary Headache Patients: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Brain Structural and Functional Changes
Study Overview
Brief Summary
Chronic headaches are associated with changes in brain structure and function that may be associated with increased suffering and disability. Understanding how Osteopathic Manipulative Therapy (OMT) affects these changes would reveal new insight into how the brain processes pain and returns to normal function. Also, demonstrating these changes would provide evidence regarding how OMT causes a reduction in pain and disability, supporting the recommendation for OMT as a primary treatment option for headaches.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •current diagnosis of primary headache (migraine, tension-type, cluster) from a healthcare provider
- •have experienced at least one headache episode a month for the previous 1 year (or longer)
- •age of PH onset was less than 50 years, currently taking medication for headaches.
Exclusion Criteria
- •presence of headaches due to some other underlying medical condition (secondary headaches)
- •traumatic brain injury
- •fibromyalgia, epilepsy
- •diagnosis of a neurodegenerative disorder
- •history of brain tumor or cancer
- •history of cervical radiculopathy (pinched nerve in the neck)
- •currently undergoing manual therapy type treatment or have a a treatment within 2 weeks of enrollment(chiropractic, OMT, massage, PT)
- •currently pregnant
- •have had an injection to treat headaches within the previous 3 months from study enrollment
- •contraindications to MRI.
Arms & Interventions
OMT Treatment Group
Intervention: Osteopathic Manipulative Therapy (Other)
Outcomes
Primary Outcomes
Brain Structural and Functional Changes
Time Frame: From enrollment to the end of treatment at 5 weeks
Structural MRI will assess physical changes in brain anatomy, including differences in the size, shape, or density of specific brain regions. For example, changes in gray matter volume or white matter integrity may indicate neuroplasticity changes response to an OMT. Functional MRI (fMRI) will measure brain activity by detecting changes in blood flow within the central pain network. When a specific brain region becomes more active, it requires more oxygen, which fMRI can detect. This will help determine whether the intervention alters brain function, such as increased activation in areas involved in movement, memory, or pain processing. Magnetic Resonance Spectroscopy (MRS), unlike standard MRI, which provides images of brain structures, will analyze chemical changes in the brain. It detects levels of important brain metabolites involved in neural signaling neuronal health.
Secondary Outcomes
- Headache Impact Test - 6 (HIT-6)(From enrollment to the end of treatment at 5 weeks)
- Short Form -36 (SF-36)(From enrollment to the end of treatment at 5 weeks)
- Depression Anxiety and Stress Scale 21 (DASS-21)(From enrollment to the end of treatment at 5 weeks)
- Headache intensity(From enrollment to the end of treatment at 5 weeks)