The Effect of Osteopathic Treatment on Craniocervico-Mandibular Dysfunction

NCT06471426 | Recruiting

• 1 other identifier: 2024-033
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.How does OMT affect CCMU muscle stiffness
2. 2.How does OMT affect jaw motion
3. 3.How does OMT affect autonomic function
4. 4.Is pain pressure threshold affected by OMT of the CCMU
5. 5.Photos taken to measure head and neck angles
6. 6.Ultrasound
7. 7.Smooth Pursuit Neck Torsion Test
8. 8.Motion Capture
9. 9.Autonomic Protocol
10. 10.Algometry
11. 11.Surveys

Conditions

Headache; Neck Pain

Outcome Measures

Primary Outcomes (7)

• Muscle Stiffness

  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)

  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

  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

  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

  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

  Pupil size changes measured in millimeters (mm)

  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.

  4-6 weeks

Secondary Outcomes (5)

• Duration, intensity and frequency of neck pain, headaches, and dizziness

  7 weeks

• Neck Disability Index (NDI)

  7 weeks

• Depression, Anxiety, Stress Scale (DASS-21)

  7 weeks

• Headache Impact Test (HIT-6)

  7 weeks

• Visual Disturbance Survey

  7 weeks

Study Arms (1)

Osteopathic Manipulative Treatment Group

EXPERIMENTAL

Other: Osteopathic Manipulative Treatment

Interventions

Osteopathic Manipulative Treatment OTHER

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.

Osteopathic Manipulative Treatment Group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male and female subjects 19-65 years old
• neck pain and/or headaches of \> 1 month duration

You may not qualify if:

• 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

Sponsors & Collaborators

• Edward Via Virginia College of Osteopathic Medicine: lead

Study Sites (1)

Edward Via College of Osteopathic Medicine-Auburn

Auburn, Alabama, 36832, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 29333365 BACKGROUND

• Ariens 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.

  PMID: 11171934 BACKGROUND

• da 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.

  PMID: 25748395 BACKGROUND

• Elbinoune 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.

  PMID: 27642428 BACKGROUND

• Kazeminasab 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.

  PMID: 34980079 BACKGROUND

• Kim 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.

  PMID: 30584494 BACKGROUND

• Silveira 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.

  PMID: 25883963 BACKGROUND

• Sojka 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.

  PMID: 31339236 BACKGROUND

• Treleaven 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.

  PMID: 24521926 BACKGROUND

• Vos 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.

  PMID: 16670840 BACKGROUND

MeSH Terms

Conditions

Headache; Neck Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Daniel Cawley, DC, MSHS, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study will utilize a pretest-posttest design which will measure changes in the following in response to a 4-week OMT intervention.

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 24, 2024
• Study Start: April 22, 2024
• Primary Completion: December 22, 2025
• Study Completion: April 22, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)