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| ID | Type | Description | Link |
|---|---|---|---|
| 2254326-1 | Other Identifier | Edward Via College of Osteopathic Medicine |
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| Name | Class |
|---|---|
| Auburn University MRI Research Center | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OMT Treatment Group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathic Manipulative Therapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Brain Structural and Functional Changes | 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. | From enrollment to the end of treatment at 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Headache Impact Test - 6 (HIT-6) | The HIT-6 (Headache Impact Test-6) measures how headaches affect daily life, including pain severity, frequency, and impact on work and social activities. | From enrollment to the end of treatment at 5 weeks |
| Short Form -36 (SF-36) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Cawley, DC | Edward Via College of Osteopathic Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auburn University MRI Center and Edward Via College of Medicine | Auburn | Alabama | 36832 | United States |
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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. |
| From enrollment to the end of treatment at 5 weeks |
| Depression Anxiety and Stress Scale 21 (DASS-21) | 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. | From enrollment to the end of treatment at 5 weeks |
| Headache intensity | Headache intensity will be measured by an 11 point numerical rating scale from 0 (no pain) to 10 (worst possible pain). | From enrollment to the end of treatment at 5 weeks |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D003027 | Cluster Headache |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D051303 | Trigeminal Autonomic Cephalalgias |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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