About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
male and female subjects 19-65 years old
neck pain and/or headaches of > 1 month duration
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Osteopathic Manipulative Treatment
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Muscle Stiffness
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)
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
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
Heart rate variability (HRV) in milliseconds (ms)
Secondary outcomes
Duration, intensity and frequency of neck pain, headaches, and dizziness
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.
Neck Disability Index (NDI)
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.
Depression, Anxiety, Stress Scale (DASS-21)
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.
Headache Impact Test (HIT-6)
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.
Sponsors and contacts
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