Osteopathic Manipulative Treatment
ProcedureUp to 4 sessions of osteopathic manipulative treatment (once per week)
NCT Number: NCT02261259
The overall goal of this project is to develop sensitive and objective clinical research tools for the assessment of head-neck motor control. In order to accomplish this goal, the investigators aim to quantify changes in head-neck motor control before and after osteopathic manipulative treatment. The investigators hypothesize that head-neck motor control will improve in neck pain participants after 4-weeks of treatment. Additionally, the investigators will compare position and force head-neck motor control between healthy controls and neck pain patients. The investigators hypothesize that baseline tests of position and force head-neck motor control will be better in healthy individuals than neck pain patients.
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Notify Me21 year–65 year
All sexes
Interventional
Not applicable
MSU Osteopathic Manual Medicine, East Lansing, Michigan, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All participants must meet all of the inclusion criteria to participate in the study. Below is a list of inclusion criteria for ALL participants:
Below is an additional list of inclusion criteria for NECK PAIN participants:
Exclusion criteria
All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation. Exclusion criteria will be self-reported. However, during each treatment session, the physicians will be watching for clinical signs and symptoms not consistent with physical findings that are suggestive of the presence of any of the exclusion criteria. In such a case, further treatment will be discontinued and the subject will be excluded.
Below is a list of exclusion criteria for ALL participants:
History of:
Unresolved symptoms from:
Current diagnosis of:
Conditions recognized by a physician any time during the study:
Below is an additional exclusion criterion for healthy control participants:
Up to 4 sessions of osteopathic manipulative treatment (once per week)
Time frame: Change from baseline to week 4 and from week 4 to 8
Participants will be seated in an upright position with their upper body secured to a backrest and will wear a head harness with an attached position sensor. The angular position of the head will be displayed on a monitor 1 meter in front of the participants and they will be asked to follow a moving target by moving their head. Accuracy will be determined by taking the difference between the target position signal and the actual head position (measured in degrees with string potentiometers).
Time frame: Change from baseline to week 4 and from week 4 to 8
Participants will be seated in an upright position with their upper body secured to a backrest and will be asked to generate force with their head against a fixed pad. The pad will be attached to a load cell that monitors how much force is being generated by their head. The force level will be displayed on a monitor 1 meter in front of the participants and they will be asked to follow a moving target by generating force with their head. Accuracy will be determined by taking the difference between target force signal and the actual head force (measured in Newtons with the load cell).
Time frame: Change from baseline to week 4 and from week 4 to 8
Participants will be sitting upright in a seat mounted to a robotic platform (Mikrolar Hexapod Robot) with their upper body secured to a backrest and will wear a head harness with an attached position sensor. The robotic platform will provide an angular perturbation to the participant about the cervical spine in the sagittal plane while the participant is asked to maintain (stabilize) their head position in the upright posture. Accuracy will be determined by measuring the amount of head displacement (measured in degrees with string potentiometers) during the perturbation trial.
Time frame: Change from baseline to week 4
Participants will be seated in an upright position with their upper body secured to a backrest and will be asked to generate force with their head against a fixed pad. They will be asked to performed 6-seconds isometric exertions in different directions. Surface EMG will be recorded from the sternocliedomastoid, splenius capitis, and upper trapezius muscles. Muscle directionality will be determined by the EMG magnitude in each direction of exertion.
Time frame: Change from week 4 to 8
Participants will be seated in an upright position with their upper body secured to a backrest and will be asked to generate force with their head against a fixed pad. They will be asked to performed 6-seconds isometric exertions in different directions. Surface EMG will be recorded from the sternocliedomastoid, splenius capitis, and upper trapezius muscles. Muscle directionality will be determined by the EMG magnitude in each direction of exertion.
Time frame: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
Assesses weekly changes in physical function, anxiety, depression, fatigue, sleep, satisfaction with social role, and pain with PROMIS-29 questionnaire.
Time frame: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
Assesses weekly changes in the use of medication for treating neck pain, including the type of medication and the quantity of medication (i.e., number of pills) with a questionnaire.
Time frame: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
Assesses weekly changes in functional activities related to neck disability with the Neck Disability Index questionnaire.
Time frame: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Beliefs questionnaire.
Michigan State University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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