Primary Headaches (Migraines, Tension, Cluster Headaches)
Conditions
Keywords
Migraine, Headaches, Osteopathic Manipulative Treatment, Brain, OMT
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.
Interventions
Evaluation looking for Somatic Dysfunction (SD) involving the head, neck, upper thoracic spine, rib cage and sacroiliac joint. OMT techniques will include a mix of the following: Osteopathic Cranial Manipulative Medicine, Muscle Energy Technique, Facilitated Positional Release, Indirect Myofascial Release, and Counterstrain.
Sponsors
Edward Via Virginia College of Osteopathic Medicine
Auburn University MRI Research Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain Structural and Functional Changes | 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
| Measure | Time frame | Description |
|---|---|---|
| Headache Impact Test - 6 (HIT-6) | From enrollment to the end of treatment at 5 weeks | The HIT-6 (Headache Impact Test-6) measures how headaches affect daily life, including pain severity, frequency, and impact on work and social activities. |
| Short Form -36 (SF-36) | From enrollment to the end of treatment at 5 weeks | The SF-36 (Short Form-36 Health Survey) is a 36 question survey that assesses overall physical and mental well-being, evaluating factors like physical function, pain, energy levels, and emotional health. |
| Depression Anxiety and Stress Scale 21 (DASS-21) | From enrollment to the end of treatment at 5 weeks | The DASS-21 (Depression, Anxiety, and Stress Scale-21) is a 21 question survey that examines emotional well-being by measuring levels of depression, anxiety, and stress. |
| Headache intensity | From enrollment to the end of treatment at 5 weeks | Headache intensity will be measured by an 11 point numerical rating scale from 0 (no pain) to 10 (worst possible pain). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel Cawley, DC
Edward Via College of Osteopathic Medicine
Outcome results
None listed