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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Daniel Cawley, DC, MS
  • Phone Number: 1334-442-4105
  • Email: dcawley@vcom.edu

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Edward Via Virginia College of Osteopathic Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Auburn University MRI Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 5, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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