Primary Headaches (Migraines, Tension, Cluster Headaches)NCT06841627
Osteopathic Manual Therapy (OMT) and Brain Structure and Function in Primary Headache Patients: A Pilot Study
A study testing Osteopathic Manipulative Therapy in people with Primary Headaches (Migraines, Tension, Cluster Headaches), run by Edward Via Virginia College of Osteopathic Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Headaches (Migraines, Tension, Cluster Headaches)
- What is being tested?
- Osteopathic Manipulative Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2025to 5 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Auburn University MRI Center and Edward Via College of Medicine
Auburn, Alabama, 36832
About this study
Official title: 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.
- Being tested
- Osteopathic Manipulative Therapy
- Keywords
- Migraine, Headaches, Osteopathic Manipulative Treatment, Brain, OMT
- Medical subject headings
- Migraine Disorders, Cluster Headache, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| OMT Treatment Group | Experimental | Not described Receives: Other: Osteopathic Manipulative Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 5 weeks
Secondary outcomes (4)
Headache Impact Test - 6 (HIT-6)
The HIT-6 (Headache Impact Test-6) measures how headaches affect daily life, including pain severity, frequency, and impact on work and social activities.
Measured: From enrollment to the end of treatment at 5 weeks
Short Form -36 (SF-36)
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.
Measured: From enrollment to the end of treatment at 5 weeks
Depression Anxiety and Stress Scale 21 (DASS-21)
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.
Measured: From enrollment to the end of treatment at 5 weeks
Headache intensity
Headache intensity will be measured by an 11 point numerical rating scale from 0 (no pain) to 10 (worst possible pain).
Measured: From enrollment to the end of treatment at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start5 Aug 2025
- Primary completion1 Oct 2025
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Headaches (Migraines, Tension, Cluster Headaches)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Via Virginia College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Auburn University
- Responsible party
- Sponsor
- Investigators
- Daniel Cawley, DC, Principal investigator, Edward Via College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841627
- Sponsor's protocol ID
- STUDY00000226
- Other IDs
- 2254326-1
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Mechanism of Osteopathic Manual Therapy (OMT) on Brain Structure and Function in Primary Headache Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT06841627
- Acronym / sponsor ID
- STUDY00000226
- Keywords
- Migraine, Headaches, Osteopathic Manipulative Treatment, Brain, OMT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Edward Via Virginia College of Osteopathic MedicineUniversity, hospital or other
- Collaborators
- Auburn University
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OMT Treatment Group | Experimental | Other: Osteopathic Manipulative Therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative TherapyEvaluation 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. | Other | OMT Treatment Group |
Primary outcome
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.
4 secondary outcomes
Headache Impact Test - 6 (HIT-6)
Time frame: 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
Depression Anxiety and Stress Scale 21 (DASS-21)
Time frame: From enrollment to the end of treatment at 5 weeks
Headache intensity
Time frame: From enrollment to the end of treatment at 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Cawley, DC principal investigator
Edward Via College of Osteopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Therapy in people with Primary Headaches (Migraines, Tension, Cluster Headaches), run by Edward Via Virginia College of Osteopathic Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Structural and Functional Changes (time frame: From enrollment to the end of treatment at 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.