Recruiting

Osteopathic Treatment

Sponsor:

Edward Via Virginia College of Osteopathic Medicine

Code:

NCT06471426

Conditions

Headache

Neck Pain

Eligibility Criteria

Sex: All

Age: 19 - 65

Healthy Volunteers: Not accepted

Interventions

Osteopathic Manipulative Treatment

Study Details

Brief 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

Conditions

Headache

Neck Pain

Study ID

NCT06471426

Start date

Apr 22, 2024

Status verified date

May, 2026

Completion date

Sep 22, 2026

Anticipated

Primary completion date

Aug 22, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Osteopathic Manipulative Treatment Group

Interventions

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 measure

  • Muscle Stiffness [ Time Frame: 4-6 weeks ]
  • Eye tracking changes measured by a smooth pursuit neck torsion test (SPNT) [ Time Frame: 4-6 weeks ]
  • Changes in jaw morphometrics during motion using a 9 -marker setup and capturing motion using VICON motion capture system [ Time Frame: 4-6 weeks ]
  • Changes in autonomic function during divided attention test, Valsalva maneuver, cold pressor test, and deep breathing via HRV [ Time Frame: 4-6 weeks ]
  • Changes in autonomic function during divided attention test, Valsalva maneuver, cold pressor test, and deep breathing via GSR [ Time Frame: 4-6 weeks ]
  • Changes in autonomic function during divided attention test, Valsalva maneuver, cold pressor test, and deep breathing via pupillary changes [ Time Frame: 4-6 weeks ]
  • Pain pressure threshold (PPT) [ Time Frame: 4-6 weeks ]

Central Contacts and Locations

Central contacts

Daniel Cawley, DC, MSHS, MS

334-442-4105dcawley@auburn.vcom.edu

Locations

Edward Via College of Osteopathic Medicine-Auburn

Recruiting

Auburn, Alabama, United States, 36832

Contacts

Daniel Cawley, DC, MSHS, MS

334-442-4105dcawley@auburn.vcom.edu

More Information

Sponsor

Edward Via Virginia College of Osteopathic Medicine

Last update posted

May 14, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Edward Via Virginia College of Osteopathic Medicine on 2026-05-14.