HeadacheNCT06471426
The Effect of Osteopathic Treatment on Craniocervico-Mandibular Dysfunction
A study testing Osteopathic Manipulative Treatment in people with Headache and Neck Pain, run by Edward Via Virginia College of Osteopathic Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- What is being tested?
- Osteopathic Manipulative Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2024to 22 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and female subjects 19-65 years old
- neck pain and/or headaches of > 1 month duration
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Edward Via College of Osteopathic Medicine-Auburn
Auburn, Alabama, 36832
About this study
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:
- How does OMT affect CCMU muscle stiffness
- How does OMT affect jaw motion
- How does OMT affect autonomic function
- Is pain pressure threshold affected by OMT of the CCMU
Participants will undergo the following interventions:
- Photos taken to measure head and neck angles
- Ultrasound
- Smooth Pursuit Neck Torsion Test
- Motion Capture
- Autonomic Protocol
- Algometry
- Surveys
Read the 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.
- Being tested
- Osteopathic Manipulative Treatment
- Medical subject headings
- Headache, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manipulative Treatment Group | Experimental | Not described Receives: Other: Osteopathic Manipulative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Stiffness
Using Shear Wave Elastography to measure stiffness (kPa) changes in the masseter, trapezius, sternocleidomastoid, and semispinalis capitis and cervicis
Measured: 4-6 weeks
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.
Measured: 4-6 weeks
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.
Measured: 4-6 weeks
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)
Measured: 4-6 weeks
Changes in autonomic function during divided attention test, Valsalva maneuver, cold pressor test, and deep breathing via GSR
Galvanic skin response (GSR) in micro-Siemens (uS)
Measured: 4-6 weeks
Changes in autonomic function during divided attention test, Valsalva maneuver, cold pressor test, and deep breathing via pupillary changes
Pupil size changes measured in millimeters (mm)
Measured: 4-6 weeks
Pain pressure threshold (PPT)
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.
Measured: 4-6 weeks
Secondary outcomes (5)
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.
Measured: 7 weeks
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.
Measured: 7 weeks
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.
Measured: 7 weeks
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.
Measured: 7 weeks
Visual Disturbance Survey
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.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start22 Apr 2024
- Primary completion22 Aug 2026
- Study completion22 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will utilize a pretest-posttest design which will measure changes in the following in response to a 4-week OMT intervention.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Via Virginia College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Cawley, Edward Via Virginia College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471426
- Sponsor's protocol ID
- 2024-033
- Status last verified
- Sep 2026
- First submitted
- 10 Jun 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abouelhuda AM, Kim HS, Kim SY, Kim YK. Association between headache and temporomandibular disorder. J Korean Assoc Oral Maxillofac Surg. 2017 Dec;43(6):363-367. doi: 10.5125/jkaoms.2017.43.6.363. Epub 2017 Dec 26.
PubMed 29333365Ariens GA, Bongers PM, Douwes M, Miedema MC, Hoogendoorn WE, van der Wal G, Bouter LM, van Mechelen W. Are neck flexion, neck rotation, and sitting at work risk factors for neck pain? Results of a prospective cohort study. Occup Environ Med. 2001 Mar;58(3):200-7. doi: 10.1136/oem.58.3.200.
PubMed 11171934da Costa DR, de Lima Ferreira AP, Pereira TA, Porporatti AL, Conti PC, Costa YM, Bonjardim LR. Neck disability is associated with masticatory myofascial pain and regional muscle sensitivity. Arch Oral Biol. 2015 May;60(5):745-52. doi: 10.1016/j.archoralbio.2015.02.009. Epub 2015 Feb 21.
PubMed 25748395Elbinoune I, Amine B, Shyen S, Gueddari S, Abouqal R, Hajjaj-Hassouni N. Chronic neck pain and anxiety-depression: prevalence and associated risk factors. Pan Afr Med J. 2016 May 27;24:89. doi: 10.11604/pamj.2016.24.89.8831. eCollection 2016.
PubMed 27642428Kazeminasab S, Nejadghaderi SA, Amiri P, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Neck pain: global epidemiology, trends and risk factors. BMC Musculoskelet Disord. 2022 Jan 3;23(1):26. doi: 10.1186/s12891-021-04957-4.
PubMed 34980079Kim DH, Kim CJ, Son SM. Neck Pain in Adults with Forward Head Posture: Effects of Craniovertebral Angle and Cervical Range of Motion. Osong Public Health Res Perspect. 2018 Dec;9(6):309-313. doi: 10.24171/j.phrp.2018.9.6.04.
PubMed 30584494Silveira A, Gadotti IC, Armijo-Olivo S, Biasotto-Gonzalez DA, Magee D. Jaw dysfunction is associated with neck disability and muscle tenderness in subjects with and without chronic temporomandibular disorders. Biomed Res Int. 2015;2015:512792. doi: 10.1155/2015/512792. Epub 2015 Mar 26.
PubMed 25883963Sojka A, Stelcer B, Roy M, Mojs E, Prylinski M. Is there a relationship between psychological factors and TMD? Brain Behav. 2019 Sep;9(9):e01360. doi: 10.1002/brb3.1360. Epub 2019 Jul 24.
PubMed 31339236Treleaven J, Takasaki H. Characteristics of visual disturbances reported by subjects with neck pain. Man Ther. 2014 Jun;19(3):203-7. doi: 10.1016/j.math.2014.01.005. Epub 2014 Jan 27.
PubMed 24521926Vos CJ, Verhagen AP, Koes BW. Reliability and responsiveness of the Dutch version of the Neck Disability Index in patients with acute neck pain in general practice. Eur Spine J. 2006 Nov;15(11):1729-36. doi: 10.1007/s00586-006-0119-7. Epub 2006 May 3.
PubMed 16670840
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Osteopathic Treatment on Craniocervico-Mandibular Dysfunction
- ClinicalTrials.gov ID
- NCT06471426
- Acronym / sponsor ID
- 2024-033
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Edward Via Virginia College of Osteopathic MedicineUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 22 Aug 2026 (actual)
- Study completion
- 22 Aug 2026 (actual)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How does OMT affect CCMU muscle stiffness
- How does OMT affect jaw motion
- How does OMT affect autonomic function
- Is pain pressure threshold affected by OMT of the CCMU
Participants will undergo the following interventions:
- Photos taken to measure head and neck angles
- Ultrasound
- Smooth Pursuit Neck Torsion Test
- Motion Capture
- Autonomic Protocol
- Algometry
- Surveys
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will utilize a pretest-posttest design which will measure changes in the following in response to a 4-week OMT intervention.
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manipulative Treatment Group | Experimental | Other: Osteopathic Manipulative Treatment |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- male and female subjects 19-65 years old
- neck pain and/or headaches of > 1 month duration
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative TreatmentThe 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. | Other | Osteopathic Manipulative Treatment Group |
Primary outcome
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.
5 secondary outcomes
Duration, intensity and frequency of neck pain, headaches, and dizziness
Time frame: 7 weeks
Neck Disability Index (NDI)
Time frame: 7 weeks
Depression, Anxiety, Stress Scale (DASS-21)
Time frame: 7 weeks
Headache Impact Test (HIT-6)
Time frame: 7 weeks
Visual Disturbance Survey
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 29333365Abouelhuda AM, Kim HS, Kim SY, Kim YK. Association between headache and temporomandibular disorder. J Korean Assoc Oral Maxillofac Surg. 2017 Dec;43(6):363-367. doi: 10.5125/jkaoms.2017.43.6.363. Epub 2017 Dec 26.
- Background: PubMed 11171934Ariens GA, Bongers PM, Douwes M, Miedema MC, Hoogendoorn WE, van der Wal G, Bouter LM, van Mechelen W. Are neck flexion, neck rotation, and sitting at work risk factors for neck pain? Results of a prospective cohort study. Occup Environ Med. 2001 Mar;58(3):200-7. doi: 10.1136/oem.58.3.200.
- Background: PubMed 25748395da Costa DR, de Lima Ferreira AP, Pereira TA, Porporatti AL, Conti PC, Costa YM, Bonjardim LR. Neck disability is associated with masticatory myofascial pain and regional muscle sensitivity. Arch Oral Biol. 2015 May;60(5):745-52. doi: 10.1016/j.archoralbio.2015.02.009. Epub 2015 Feb 21.
- Background: PubMed 27642428Elbinoune I, Amine B, Shyen S, Gueddari S, Abouqal R, Hajjaj-Hassouni N. Chronic neck pain and anxiety-depression: prevalence and associated risk factors. Pan Afr Med J. 2016 May 27;24:89. doi: 10.11604/pamj.2016.24.89.8831. eCollection 2016.
- Background: PubMed 34980079Kazeminasab S, Nejadghaderi SA, Amiri P, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Neck pain: global epidemiology, trends and risk factors. BMC Musculoskelet Disord. 2022 Jan 3;23(1):26. doi: 10.1186/s12891-021-04957-4.
- Background: PubMed 30584494Kim DH, Kim CJ, Son SM. Neck Pain in Adults with Forward Head Posture: Effects of Craniovertebral Angle and Cervical Range of Motion. Osong Public Health Res Perspect. 2018 Dec;9(6):309-313. doi: 10.24171/j.phrp.2018.9.6.04.
- Background: PubMed 25883963Silveira A, Gadotti IC, Armijo-Olivo S, Biasotto-Gonzalez DA, Magee D. Jaw dysfunction is associated with neck disability and muscle tenderness in subjects with and without chronic temporomandibular disorders. Biomed Res Int. 2015;2015:512792. doi: 10.1155/2015/512792. Epub 2015 Mar 26.
- Background: PubMed 31339236Sojka A, Stelcer B, Roy M, Mojs E, Prylinski M. Is there a relationship between psychological factors and TMD? Brain Behav. 2019 Sep;9(9):e01360. doi: 10.1002/brb3.1360. Epub 2019 Jul 24.
- Background: PubMed 24521926Treleaven J, Takasaki H. Characteristics of visual disturbances reported by subjects with neck pain. Man Ther. 2014 Jun;19(3):203-7. doi: 10.1016/j.math.2014.01.005. Epub 2014 Jan 27.
- Background: PubMed 16670840Vos CJ, Verhagen AP, Koes BW. Reliability and responsiveness of the Dutch version of the Neck Disability Index in patients with acute neck pain in general practice. Eur Spine J. 2006 Nov;15(11):1729-36. doi: 10.1007/s00586-006-0119-7. Epub 2006 May 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment in people with Headache and Neck Pain, run by Edward Via Virginia College of Osteopathic Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Stiffness (time frame: 4-6 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06471426, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.