NCT06471426 · Edward Via Virginia College of Osteopathic Medicine
The Effect of Osteopathic Treatment on Craniocervico-Mandibular Dysfunction
What this study is about
The goal of this clinical trial is to measure the effects of osteopathic manipulative treatment (OMT) on tissues of the craniocervico-mandibular unit (CCMU) in individuals with neck pain and headaches. The main questions to answer are: 1. How does OMT affect CCMU muscle stiffness 2. How does OMT affect jaw motion 3. How does OMT affect autonomic function 4.
View original scientific description
The goal of this clinical trial is to measure the effects of osteopathic manipulative treatment (OMT) on tissues of the craniocervico-mandibular unit (CCMU) in individuals with neck pain and headaches. The main questions to answer are: 1. How does OMT affect CCMU muscle stiffness 2. How does OMT affect jaw motion 3. How does OMT affect autonomic function 4. Is pain pressure threshold affected by OMT of the CCMU Participants will undergo the following interventions: 1. Photos taken to measure head and neck angles 2. Ultrasound 3. Smooth Pursuit Neck Torsion Test 4. Motion Capture 5. Autonomic Protocol 6. Algometry 7.
Interventions
OTHER
Osteopathic Manipulative Treatment
The following methods of evaluation and treatment will be utilized on all subjects: Indirect myofascial release to the cervical region, osteopathic cranial manipulation, sacral articular technique.
Primary outcome measures
Muscle Stiffness
Time frame: 4-6 weeks
Using Shear Wave Elastography to measure stiffness (kPa) changes in the masseter, trapezius, sternocleidomastoid, and semispinalis capitis and cervicis
Eye tracking changes measured by a smooth pursuit neck torsion test (SPNT)
Time frame: 4-6 weeks
Ratio of (eye velocity) to (on-screen moving red dot velocity) in degrees/second. This measurement will be taken in 3 different positions, neutral, 45ᵒ of left head rotation, and 45ᵒ of right head rotation.
Changes in jaw morphometrics during motion using a 9 -marker setup and capturing motion using VICON motion capture system
Time frame: 4-6 weeks
Measurement of jaw morphometry during the following motions: depression, elevation, right and left lateral excursion, and protrusion. Investigators will measure motion morphometrics of cervical rotation, flexion, extension, and lateral flexion. Reflective skin markers will be used as X/Y/Z coordinates for morphometric analysis.
Changes in autonomic function during divided attention test, Valsalva maneuver, cold pressor test, and deep breathing via HRV
Time frame: 4-6 weeks
Heart rate variability (HRV) in milliseconds (ms)
Changes in autonomic function during divided attention test, Valsalva maneuver, cold pressor test, and deep breathing via GSR
Time frame: 4-6 weeks
Galvanic skin response (GSR) in micro-Siemens (uS)
Changes in autonomic function during divided attention test, Valsalva maneuver, cold pressor test, and deep breathing via pupillary changes
Time frame: 4-6 weeks
Pupil size changes measured in millimeters (mm)
Pain pressure threshold (PPT)
Time frame: 4-6 weeks
Using algometry to measure PPT (kilograms per square centimeter (kg/cm2)) in the following locations bilaterally: 2cm lateral and superior to the C2 spinous process, masseter 2.5cm anterior and 1.5cm inferior to the tragus of the ear, and over the middle of the thenar eminence.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- male and female subjects 19-65 years old
- neck pain and/or headaches of \> 1 month duration
Exclusion criteria
- prior cervical or thoracic spinal surgery
- diagnosis cervical radiculopathy or pinched nerve in the neck
- diagnosis of jaw disease or dysfunction
- diagnosis of connective tissue or muscle disorders
- diagnosis of cancer
- previous spinal cord injury
- Inflammatory arthritis and fibromyalgia
- eye movement disorder
- known pregnancy (hormonal changes affecting tissues could be a confounding variable)
- tobacco use
- known diabetes or prediabetes
- allergy to ultrasound gel (propylene glycol)
- history of manual therapy treatment within the past 2 weeks
- history of injection for pain within the past month
- currently taking muscle relaxers
Where
- Auburn, Alabama
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2026 · Source of record for eligibility and locations