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

May 5, 2026 updated by: Edward Via Virginia College of Osteopathic Medicine

Exploring the Mechanism of Osteopathic Manual Therapy (OMT) on 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Auburn, Alabama, United States, 36832
        • Auburn University MRI Center and Edward Via College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OMT Treatment Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 5 weeks
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.
From enrollment to the end of treatment at 5 weeks
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.
From enrollment to the end of treatment at 5 weeks
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).
From enrollment to the end of treatment at 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edward Via Virginia College of Osteopathic Medicine

Collaborators

Auburn University MRI Research Center

Investigators

  • Principal Investigator: Daniel Cawley, DC, Edward Via College of Osteopathic Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2025

Primary Completion (Actual)

October 1, 2025

Study Completion (Actual)

May 5, 2026

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

February 24, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000226
  • 2254326-1 (Other Identifier: Edward Via College of Osteopathic Medicine)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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