Ignite Creation Date:
2024-07-17 @ 10:56 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471426
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-10
Brief Title:
The Effect of Osteopathic Treatment on Craniocervico-Mandibular Dysfunction
Sponsor:
Edward Via Virginia College of Osteopathic Medicine
Organization:
Edward Via Virginia College of Osteopathic Medicine
Study Overview
Official Title:
The Effect of Osteopathic Treatment on Craniocervico-Mandibular Dysfunction
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None