Effectiveness of Pain Neuroscience Education (PNE) to Veterans With Post-Traumatic Stress and Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
This trial compared traditional pain and stress education plus physical therapy to pain neuroscience education plus physical therapy in individuals with post-traumatic stress and chronic low back pain.
详细描述
Veterans and Service Members with low back pain (LBP) will be recruited for this research. Once Veterans consent to participate in this research, participants will undergo baseline testing. Next, participants will randomly be assigned to one of two types of education: pain neuroscience education or traditional biomedical education. Each Veteran will receive 30 minutes of interactive education once a week for 4 weeks, depending on their group assignment. Following each education session, Veterans will participate in an exercise class that will last approximately 30 minutes. After the 4 week intervention, Veterans will complete the same questionnaires and measures as at the beginning of the program. Veterans will also complete subjective questionnaires at 8 weeks. Finally, healthcare utilization will be measured for 12 months following the research intervention.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain located between the 12th rib and buttocks that in the opinion of the screening examiner is originating from the lumbar region
- •Current episode of back pain duration of 3 months or longer
- •Active duty military or Veteran
- •Read and speak English well enough to provide informed consent and follow study instructions
排除标准
- •History of prior surgery to the lumbosacral spine within the previous 12 months
- •Presence of neurogenic LBP defined by a positive contralateral straight leg raise (reproduction of symptoms below 45 degrees) or reflex, sensation, or strength deficits in a pattern consistent with nerve root compression
- •Medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection, or systemic disease
- •Discharged from physical therapy within the past 3 months for lower back pain
- •Current diagnosis of psychotic conditions or medications (bi-polar, schizophrenia, personality disorder).
- •Substance abuse or psychosis within 6 months of research.
- •Unable to discontinue other active therapies until completion of clinical trial follow-up (8 weeks).
- •Suicidal ideation
- •Current pregnancy
结局指标
主要结局
Numeric Pain Rating Scale (NPRS)
时间窗: 8-weeks
The NPRS is an 11-point scale used to rate subjective pain intensity. The NPRS has been shown to have good validity and reliability. The scale ranges from 0 to 10 and has been shown to have acceptable responsiveness in patients with LBP. This study's scale was anchored at 0, "no pain at all", to 10, "the worst pain you could imagine."
PTSD Check-list for Diagnostic and Statistical Manual of Mental Disorders (DSM 5) (PCL)
时间窗: 8-weeks
The PCL is a 20-item checklist that measures the clusters of symptoms associated with PTSD according to the revised DSM. Scores range from 0-80 with higher numbers indicating higher PTSD symptomology.
Roland-Morris Disability Questionnaire (RMDQ)
时间窗: 8-weeks
The RMDQ is a subjective measure of disability recommended for LBP. Users are asked to identify among 24 activities or statements that are influenced by their back pain. The answers provide a score between 0 and 24, with higher scores representing more disability.
次要结局
- Brief Survey of Pain Attitudes (SOPA-35)(8-weeks)
- "Stressometer"(8-weeks)
- Pain Self-Efficacy Questionnaire (PSEQ)(8-weeks)
- Lumbar Spine Pain Pressure Threshold (PPT)(4-weeks)
- Post-program questionnaire(8-weeks)
- Pain Catastrophizing Scale (PCS)(8-weeks)
- Spinal flexion(4-weeks)
- Healthcare utilization, Invasive Procedures(12-months)
- Suprascapular Pain Pressure Threshold (PPT)(4-weeks)
- Healthcare utilization, Cost(12-months)
研究者
Timothy Benedict
Associate Professor
Keller Army Community Hospital