An interventional study of Osteopathic Manipulative Therapy in Primary Headaches (Migraines, Tension, Cluster Headaches), sponsored by Edward Via Virginia College of Osteopathic Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Edward Via Virginia College of Osteopathic Medicine · Not applicable, Interventional, and Basic science
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's enrollment of 31 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Edward Via Virginia College of Osteopathic Medicine is the lead sponsor of 24 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Osteopathic Manipulative Therapy
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.
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.
Time frame: From enrollment to the end of treatment at 5 weeks
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.
Time frame: From enrollment to the end of treatment at 5 weeks
Short Form -36 (SF-36)
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.
Time frame: 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.
Time frame: 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).
Time frame: From enrollment to the end of treatment at 5 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2025 to primary completion in Oct 2025, 1 month.
Of 309 non-industry interventional studies with no phase under Migraine Disorders, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 1 month is below that.
Counting every sponsor, half of 358 studies reached it within 15 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Edward Via Virginia College of Osteopathic Medicine