The Effect of Osteopathic Treatment on Craniocervico-Mandibular Dysfunction

May 11, 2026 updated by: Daniel Cawley, Edward Via Virginia College of Osteopathic Medicine

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Myofascial pain is a major health problem that results in a decrease in life quality and functioning, and it imposes a burden on healthcare systems. Muscles and joints of the cervical spine contain numerous sensory receptors that are important for the integration of head and neck movements with temporomandibular joint and eye movements. In humans, jaw and neck movements are integrated, possessing a high degree of spatiotemporal consistency. This is necessary to maintain natural jaw function. Because of neural and myofascial connections, dysfunction in one region can cause dysfunction and pain in a neighboring region. Jaw and cervical spine dysfunction have been linked previously. Orofacial pain and temporomandibular joint dysfunction are both associated with increased stiffness of the masticatory muscles and neck disability and muscle tenderness. Also, abnormal craniocervical posture that manifests as forward head malposition with hyperextension of the upper cervical is commonly associated with dysfunction of the CCMU. Considering head and neck postures can influence muscle stiffness and activity, it is plausible that positional changes in the neck, such as poor posture, are part of a larger somatic dysfunction sequela that reflects biomechanical alterations of the CCMU that can eventually lead to chronic pain and dysfunction in eye and jaw motion. In addition to myofascial dysfunction, the role of the autonomic nervous system (ANS) in chronic pain has been documented and is related to dysfunctional pain that continues in the absence of noxious stimuli. Previous studies have demonstrated a correlation between neck pain and temporomandibular dysfunction and pain, impaired eye movements, visual disturbances, and autonomic dysfunction.

Manual therapies have been shown to restore myofascial and autonomic balance. OMT directed at the cervical region can restore balance to both the CCMU and the autonomic nervous system, which can improve function and decrease pain. Treatment of the deep neck muscles, including the suboccipital muscles, is effective at improving neck pain, disability and range of motion. Also, this can manifest as an improvement in jaw and eye motion, and a restoration of balance within the autonomic nervous system. Further research is needed to better understand the role of CCMU dysfunction in chronic pain conditions of the head and neck and to provide a mechanistic understanding of OMT in the treatment of CCMU dysfunction.

The primary objective is to measure the effects of OMT on tissues of the CCMU in individuals with neck pain and headaches. Specifically, investigators will measure the following as part of this objective:

  • Stiffness changes in the masseter, trapezius, sternocleidomastoid, and semispinalis capitis and cervicis.
  • Eye tracking changes measured by a smooth pursuit neck torsion test (SPNT).
  • Changes in jaw morphometrics during motion using a 9 -marker setup and capturing motion using VICON.
  • Changes in autonomic function (heartrate variability, skin conductance, pupillary response) using a battery of tests including divided attention test, Valsalva maneuver, cold pressor test, and deep breathing.
  • Pain pressure threshold measured by algometry.

A secondary objective is to demonstrate a relationship between the clinical presentation of CCMU dysfunction and self-reported complaints of stress, anxiety, pain, and disability and how OMT affects these self-reported measures. To achieve this secondary objective, the investigators will use the following:

  • Self-reported visual disturbances measured by survey.
  • Depression, Anxiety, and Stress measured by Depression, Anxiety, Stress Scale (DASS-21).
  • Average neck pain, headaches, and temporomandibular joint pain duration, intensity and frequency measured by survey.
  • Functional ability measured by the neck disability index (NDI).
  • Headaches measured by the Headache impact test (HIT-6).

This research aims to answer possible mechanisms of OMT intervention in CCMU dysfunction that presents clinically as neck pain, headache, dizziness, and visual disturbances. In addition, the investigators aim to demonstrate a relationship between self-reported measures of pain and disability and dysfunction while demonstrating improvements in these measures because of OMT treatment.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Auburn, Alabama, United States, 36832
        • Recruiting
        • Edward Via College of Osteopathic Medicine-Auburn
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Osteopathic Manipulative Treatment Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4-6 weeks
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.
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
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.
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
Heart rate variability (HRV) in milliseconds (ms)
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
Galvanic skin response (GSR) in micro-Siemens (uS)
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
Pupil size changes measured in millimeters (mm)
4-6 weeks
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.
4-6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration, intensity and frequency of neck pain, headaches, and dizziness
Time Frame: 7 weeks
Using Numerical Rating Scale (NRS) to measure. Scales from 0-10 with 0 indicating no pain and 10 indicating severe pain. Scales from 1-5 with 1 indicating no pain ever and 5 indicating pain always.
7 weeks
Neck Disability Index (NDI)
Time Frame: 7 weeks
10-item patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living. Questions are rated from 0-5 with 0 indicating no neck disability and 5 indicating severe neck disability. The sections are summed for a score range of 0-50 with a higher score indicating greater disability.
7 weeks
Depression, Anxiety, Stress Scale (DASS-21)
Time Frame: 7 weeks
Set of 3 self-reported subscales designed to measure depression, anxiety, and stress in adults. It consists of 21 items, with 7 questions dedicated to each of the subscales. For each question, the answers are scored from 0-4 with 0 being "did not apply to me at all" and 4 being "very much or most of the time." Each question related to the subsets of anxiety, depression, and stress are scored from ranges of (0-20+), (0-28+), and (0-34+), respectively. A lower score indicates normal with a higher score indicating more severe condition.
7 weeks
Headache Impact Test (HIT-6)
Time Frame: 7 weeks
6-item survey developed to assess the impact of headaches on a patient's daily life, including frequency of severe pain and pain related functional limitations. There are 5 choices for each question, which are then scored and totaled for a range from 36-78. A higher score indicates higher impact of headaches on daily life.
7 weeks
Visual Disturbance Survey
Time Frame: 7 weeks
16-item survey that measures self-reported visual complaints. Each visual complaint asks about intensity 0-3 (0=none, 3=severe) and frequency 0-4 (0=never, 4=always). These scores are multiplied to get a score out of 12. A higher score indicates more frequent and severe disturbances for each visual complaint.
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edward Via Virginia College of Osteopathic Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2024

Primary Completion (Estimated)

August 22, 2026

Study Completion (Estimated)

September 22, 2026

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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