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

NCT06841627 | Completed

• 2 other identifiers: STUDY000002262254326-1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Headaches (Migraines, Tension, Cluster Headaches)

Keywords

Migraine; Headaches; Osteopathic Manipulative Treatment; Brain; OMT

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

Study Arms (1)

OMT Treatment Group

EXPERIMENTAL

Other: Osteopathic Manipulative Therapy

Interventions

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.

OMT Treatment Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edward Via Virginia College of Osteopathic Medicine: lead
• Auburn University MRI Research Center: collaborator

Study Sites (1)

Auburn University MRI Center and Edward Via College of Medicine

Auburn, Alabama, 36832, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Cluster Headache; Headache

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trigeminal Autonomic Cephalalgias; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Daniel Cawley, DC

  Edward Via College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 24, 2025
• Study Start: August 5, 2025
• Primary Completion: October 1, 2025
• Study Completion: May 5, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)