Feasibility of Implementing Manual Medicine in the Multimodal Management of Veterans and Service Members With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Low-Back Pain Specific Pain Intensity
研究概览
简要总结
The goal of this clinical trial is to learn if adding Osteopathic Manipulative Therapy (OMT) to the usual medical care provided at the VA (usual VA care) improves treatment outcomes in individuals with chronic low back pain (CLBP). OMT is a set of hands-on techniques a doctor uses to move a patient's muscles and joints which include stretching, gentle pressure, resistance and applying forces to specific areas of the body. This feasibility clinical trial aims to learn about the treatment effects (e.g., effect sizes) of adding OMT to the usual medical care provided at the VA (Usual VA Care) in individuals with LBP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older
- •Seeking care for LBP from a participating VA clinic
- •Able to follow study protocol
- •Willing to be randomized to Usual VA Care or Usual VA Care + OMT
- •Individuals with pain primarily in the LBP region lasting > 3 months and present on at least half the days during the past 6 months
- •Pain rating over the past 7 days equal to or greater than 3/10 as indicated on the Numeric Rating Scale for Pain
排除标准
- •Signs of serious pathology as a cause of LBP
- •Underlying systemic or inflammatory conditions
- •Neurological diseases
- •Pregnancy
- •Previous back surgery or spinal fracture within the past year
- •Active workers' compensation or litigation for back pain
- •Any conditions impeding study protocol implementation or contraindication to OMT
- •No PM&R, OMT, chiropractic, or physical treatment where manual techniques are utilized within last 3mo
研究组 & 干预措施
Usual VA Care + OMT Group
Participants in this group will receive your usual VA care plus OMT. The addition of OMT is the research portion of the treatment. During the physician prescribed usual care visits, participants will receive the OMT treatment. During OMT (the research portion), a physician may move participants muscles and joints using hands-on techniques including stretching, gentle pressure and resistance, as well as applying forces to specific areas of the body. While receiving OMT, participants may be asked to change positions such as standing, sitting, or lying on your back, stomach or side. This treatment will be provided by the VA physicians involved in this study.
干预措施: Usual VA Care (Procedure)
Usual VA Care Group
All study participants will receive usual VA care that will be provided by a physiatrist at the Hines VA. After taking their medical history, they will perform a physical exam to assess their conditions. Based on the physical exam, the physicians may recommend more testing and/or treatment procedures.
干预措施: Usual VA Care (Procedure)
Usual VA Care + OMT Group
Participants in this group will receive your usual VA care plus OMT. The addition of OMT is the research portion of the treatment. During the physician prescribed usual care visits, participants will receive the OMT treatment. During OMT (the research portion), a physician may move participants muscles and joints using hands-on techniques including stretching, gentle pressure and resistance, as well as applying forces to specific areas of the body. While receiving OMT, participants may be asked to change positions such as standing, sitting, or lying on your back, stomach or side. This treatment will be provided by the VA physicians involved in this study.
干预措施: Osteopathic manipulative treatment (Procedure)
结局指标
主要结局
Low-Back Pain Specific Pain Intensity
时间窗: Baseline, 12 weeks, and 24 weeks
A numeric pain rating scale (NPRS) question adapted by the BACPAC to obtain pain rating for over last 7 days.
次要结局
- Pain Catastrophizing Scale - Short Form 6 (PCS-6)(Baseline, 12 weeks, and 24 weeks)
- Sleep Duration(Baseline, 12 weeks, and 24 weeks)
- Radicular Pain Questions(Baseline, 12 weeks, and 24 weeks)
- Abbreviated Pain Somatization(Baseline, 12 weeks, and 24 weeks)
- Widespread Pain Inventory(Baseline, 12 weeks, and 24 weeks)
- Low Back Pain Duration and Frequency(Baseline, 12 weeks, and 24 weeks)
- The Tobacco, Alcohol, Prescription medications, and other Substance Part 1 (TAPS1)(Baseline, 12 weeks, and 24 weeks)
- Alcohol Use Disorders Identification Test (AUDIT-C)(Baseline, 12 weeks, and 24 weeks)
- Healing Encounters and Attitudes Lists (HEAL)(Baseline, 12 weeks, and 24 weeks)
- Patients' Global Impression of Change (PGIC)(Baseline, 12 weeks, and 24 weeks)
- Pain, Enjoyment, General Activity Scale (PEG)(Baseline, 12 weeks, and 24 weeks)
- Patient-Reported Outcomes Measurement Information System (PROMIS)(Baseline, 12 weeks, and 24 weeks)
- Patient Health Questionnaire (PHQ-2)(Baseline, 12 weeks, and 24 weeks)
- Healthcare utilization cost(Baseline, 12 weeks, and 24 weeks)
- Generalized Anxiety Disorder 2-item (GAD-2)(Baseline, 12 weeks, and 24 weeks)
- Brief Pain Inventory (BPI)(Baseline, 12 weeks, and 24 weeks)
研究者
Clarence Nicodemus
VA WOC
Edward Hines Jr. VA Hospital