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

Not Applicable

Not yet recruiting

• Conditions: Primary Headaches (includes Migraines, Tension, Cluster Headaches)

• Registration Number: NCT06841627
• Lead Sponsor: Edward Via Virginia College of Osteopathic Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-19
• Study First Posted: 2025-02-24
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18
• Study Start: 2025-04-01
• Primary Completion: 2026-02
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Brain Structural and Functional Changes	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 Outcome Measures

Name	Time	Method
Headache Impact Test - 6 (HIT-6)	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.
Short Form -36 (SF-36)	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.
Depression Anxiety and Stress Scale 21 (DASS-21)	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.
Headache intensity	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).

Trial Locations

Locations (1)

Auburn University MRI Center and Edward Via College of Medicine; 🇺🇸 Auburn, Alabama, United States