Osteopathic Manipulative Treatment and Postural Control: Systems Engineering Approach
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 63
- 试验地点
- 6
- 主要终点
- Change in postural control
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 postural control of the trunk. In order to accomplish this goal, we aim to quantify balance performance in an unstable seated task. Specifically, the investigators will quantify balance performance in low back pain participants before and after osteopathic manipulative treatment. The investigators hypothesize that there will be a significant improvement in balance performance after a single session of osteopathic manipulative treatment as well as after 4 sessions of osteopathic manipulative treatment and this improvement will be greater than any learning effect.
A secondary objective of this study is to quantify differences in patient-oriented outcome measures (e.g., self-reported pain, disability) in low back pain participants before and after osteopathic manipulative treatment. The investigators hypothesize that there will be a significant improvement in these self-reported outcomes following osteopathic manipulative treatment. The association between improvement in postural control parameters and patient-oriented measures will also be explored.
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
- 否
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 LBP 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.
- •Willing to be randomized to either immediate or delayed treatment group.
- •Musculoskeletal pain - primarily in the low back region
- •Pain rating equal to or greater than 3 out of10 as indicated on the Numeric Rating Scale for Pain
- •Disability equal to or greater than 26% as indicated on the Oswestry Disability Questionnaire
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:
- •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
- •Obesity (BMI>32)
- •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
- •Cauda equine syndrome
- •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
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)
结局指标
主要结局
Change in postural control
时间窗: Change from baseline to shortly after first treatment (1-2 days), from baseline to an expected average of week 4, and from week 4 to an expected average of week 8.
Postural control will be assessed in an unstable seated task, in which subjects will be asked to balance on a specially designed seat. The average deviations from the neutral seat position will be measured in degrees.
Change in trunk muscle reflex latency
时间窗: Change from baseline to shortly after first treatment (1-2 days), from baseline to an expected average of week 4, and from week 4 to an expected average of week 8.
Subjects will be pulling with their trunk on a cable held by an electromagnet. The electromagnet will be suddenly released. Trunk muscle response to sudden load release will be measured on electromyographical recordings in milliseconds.
次要结局
- Change in Oswestry Disability Index(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 concomitant medication(The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).tcome measure until the end, an 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