Effects of Osteopathic Manipulative Treatment on Neuromuscular Control of the Head-neck System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 6
- 主要终点
- Change from baseline to week 4 and from week 4 to 8 in head position tracking accuracy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
- •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
- •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.
研究组 & 干预措施
Immediate treatment
This arm receives osteopathic manipulative treatment shortly after enrollment
干预措施: Osteopathic manipulative treatment (Procedure)
Delayed treatment
This arm receives osteopathic manipulative treatment approximately 4 weeks after enrollment
干预措施: Osteopathic manipulative treatment (Procedure)
Healthy control (no neck pain)
In this arm, healthy controls are tested at baseline.
结局指标
主要结局
Change from baseline to week 4 and from week 4 to 8 in head position tracking accuracy
时间窗: 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).
Change from baseline to week 4 and from week 4 to 8 in head force tracking accuracy
时间窗: 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).
Change from baseline to week 4 and from week 4 to 8 in head position stabilization accuracy
时间窗: 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.
Change from baseline to week 4 in neck force and muscle activation directionality
时间窗: 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.
Change from week 4 to 8 in neck force and muscle activation directionality
时间窗: 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.
次要结局
- Change in concomitant medication(The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).)
- Change in Patient Reported Outcomes Measurement Information System (PROMIS)(The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).)
- Change in neck disability(The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).)
- Change in fear avoidance behavior(The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).)
研究者
Jacek Cholewicki
Walter F. Patenge Professor
Michigan State University