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NCT Number: NCT06841627

Osteopathic Manual Therapy (OMT) and Brain Structure and Function in Primary Headache Patients: A Pilot Study

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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Key information

Conditions

Primary Headaches (Migraines, Tension, Cluster Headaches) Brain Diseases Central Nervous System Diseases Cluster Headache Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Trigeminal Autonomic Cephalalgias

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auburn University MRI Center and Edward Via College of Medicine

Auburn, Alabama, 36832, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Headache Impact Test - 6 (HIT-6)

    Time frame: 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.

  2. Short Form -36 (SF-36)

    Time frame: 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.

  3. Depression Anxiety and Stress Scale 21 (DASS-21)

    Time frame: 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.

  4. Headache intensity

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Edward Via Virginia College of Osteopathic Medicine

Other

Collaborators

  • Auburn University

Registry information

Official study title

Exploring the Mechanism of Osteopathic Manual Therapy (OMT) on Brain Structure and Function in Primary Headache Patients: A Pilot Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 24, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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