The Effect of Osteopathic Treatment on Craniocervico-Mandibular Dysfunction (NCT06471426) | Clinical Trial Compass
RecruitingNot Applicable
The Effect of Osteopathic Treatment on Craniocervico-Mandibular Dysfunction
United States30 participantsStarted 2024-04-22
Plain-language summary
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. Surveys
Who can participate
Age range
19 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Muscle Stiffness
Timeframe: 4-6 weeks
2
Eye tracking changes measured by a smooth pursuit neck torsion test (SPNT)
Timeframe: 4-6 weeks
3
Changes in jaw morphometrics during motion using a 9 -marker setup and capturing motion using VICON motion capture system
Timeframe: 4-6 weeks
4
Changes in autonomic function during divided attention test, Valsalva maneuver, cold pressor test, and deep breathing via HRV
Timeframe: 4-6 weeks
5
Changes in autonomic function during divided attention test, Valsalva maneuver, cold pressor test, and deep breathing via GSR
Timeframe: 4-6 weeks
6
Changes in autonomic function during divided attention test, Valsalva maneuver, cold pressor test, and deep breathing via pupillary changes
Timeframe: 4-6 weeks
7
Pain pressure threshold (PPT)
Timeframe: 4-6 weeks
Trial details
NCT IDNCT06471426
SponsorEdward Via Virginia College of Osteopathic Medicine