Effects of Osteopathic Manipulative Treatment on Neuromuscular Control of the Head-neck System

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Osteopathic Manipulative Treatment on Neuromuscular Control of the Head-neck System

Conditions
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Neck Pain

Intervention / Treatment
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* Procedure: Osteopathic manipulative treatment


Participation Criteria
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Eligibility Criteria
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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: Age 21-65 years Independently ambulatory Able to speak and read English Able to understand study procedures and to comply with them for the entire length of the study. Below is an additional list of inclusion criteria for NECK PAIN participants: Willing to be randomized to either immediate or delayed treatment group. Musculoskeletal pain - primarily in the cervical region lasting longer than 3 months Pain rating greater than or equal to 3 out of 10 as indicated on the Numeric Rating Scale for Pain Neck Disability greater than or equal to 30% as indicated on the Neck Disability Index 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: Inability or unwillingness of individual to give written informed consent. Physical therapy or any other form of manual medicine (e.g., Osteopathic Manipulative Medicine, Chiropractic Manipulation, etc.), acupuncture or spinal injections within one month prior to study enrollment Workers' compensation benefits in the past 3 months or ongoing medical legal issues Possibly pregnant Extreme obesity (BMI>36) Currently using electrical implants (e.g., cardiac pacemakers, drug delivery pumps, etc.) History of: Spinal surgery Spinal fracture Spinal infection (e.g., osteomyelitis) Cancer Unresolved symptoms from: Head trauma Inner ear infection with associated balance and coordination problems Orthostatic hypotension Uncontrolled hypertension Vestibular disorder (e.g. vertigo) Current diagnosis of: Significant spinal deformity (e.g., scoliosis > 20 degrees, torticollis) Ankylosing spondylitis Spondylolisthesis grades III or IV Rheumatoid arthritis Osteoporosis Angina or congestive heart failure symptoms Active bleeding or infection in the back Blindness Seizures Neurologic disease (e.g., Parkinson's disease, multiple sclerosis, cerebral palsy, Alzheimer's disease, amyotrophic lateral sclerosis, stroke or transient ischemic attack in the past year, cervical dystonia) Conditions recognized by a physician any time during the study: Significant or worsening signs of neurologic deficit Symptoms are not consistent with mechanical findings Other conditions impeding protocol implementation Below is an additional exclusion criterion for healthy control participants: • Based on the minimal clinically important difference of 2 points (Childs et al., 2005), healthy controls with 2 points or greater pain on NRS will not be eligible to participate.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate treatment<br>This arm receives osteopathic manipulative treatment shortly after enrollment | Procedure: Osteopathic manipulative treatment<br>* Up to 4 sessions of osteopathic manipulative treatment (once per week)<br>|
| Experimental: Delayed treatment<br>This arm receives osteopathic manipulative treatment approximately 4 weeks after enrollment | Procedure: Osteopathic manipulative treatment<br>* Up to 4 sessions of osteopathic manipulative treatment (once per week)<br>|
| No Intervention: Healthy control (no neck pain)<br>In this arm, healthy controls are tested at baseline. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 4 and from week 4 to 8 in head position tracking accuracy | 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). | Change from baseline to week 4 and from week 4 to 8 | 
| Change from baseline to week 4 and from week 4 to 8 in head force tracking accuracy | 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). | Change from baseline to week 4 and from week 4 to 8 | 
| Change from baseline to week 4 and from week 4 to 8 in head position stabilization accuracy | 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. | Change from baseline to week 4 and from week 4 to 8 | 
| Change from baseline to week 4 in neck force and muscle activation directionality | 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. | Change from baseline to week 4 | 
| Change from week 4 to 8 in neck force and muscle activation directionality | 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. | Change from week 4 to 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) | Assesses weekly changes in physical function, anxiety, depression, fatigue, sleep, satisfaction with social role, and pain with PROMIS-29 questionnaire. | The expected average is weekly for this outcome measure until the end (expected average of 8 weeks). | 
| Change in concomitant medication | 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. | The expected average is weekly for this outcome measure until the end (expected average of 8 weeks). | 
| Change in neck disability | Assesses weekly changes in functional activities related to neck disability with the Neck Disability Index questionnaire. | The expected average is weekly for this outcome measure until the end (expected average of 8 weeks). | 
| Change in fear avoidance behavior | Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Beliefs questionnaire. | The expected average is weekly for this outcome measure until the end (expected average of 8 weeks). |