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

NCT ID: NCT06841627

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-05

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Headaches (Migraines, Tension, Cluster Headaches)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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OMT Treatment Group

Group Type EXPERIMENTAL

Osteopathic Manipulative Therapy

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Auburn University MRI Research Center

UNKNOWN

Sponsor Role collaborator

Edward Via Virginia College of Osteopathic Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Cawley, DC

Role: PRINCIPAL_INVESTIGATOR

Edward Via College of Osteopathic Medicine

Locations

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Auburn University MRI Center and Edward Via College of Medicine

Auburn, Alabama, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Daniel Cawley, DC, MS

Role: CONTACT

1334-442-4105

Adil Bashir, PhD

Role: CONTACT

Facility Contacts

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Daniel Cawley, DC, MS

Role: primary

334-442-4105

Other Identifiers

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2254326-1

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00000226

Identifier Type: -

Identifier Source: org_study_id

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