Functional Impact of PENS for 65+ Chronic Low Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Roland and Morris questionnaire
研究概览
简要总结
The purpose of this study is to determine whether a form of electrical acupuncture, called percutaneous electrical nerve stimulation (PENS), can reduce pain and disability in older adults with chronic low back pain (LBP). This study will also determine the effects of general conditioning and aerobic exercise (GCAE) on chronic LBP.
详细描述
Each year, a significant number of elderly individuals experience at least one episode of LBP. When LBP becomes chronic, it can lead to functional and emotional impairment, increased health care utilization, and decreased quality of life. Standard treatment for LBP typically consists of non-opioid analgesics and physical therapy; however, analgesic-associated morbidity in older adults often limits their utility. This study will determine the efficacy of PENS treatment, a neuroanatomically guided form of electroacupuncture, and exercise in reducing pain in older adults with chronic LBP.
Participants will be randomly assigned to one of four treatment groups: PENS alone, PENS placebo, PENS plus GCAE, or PENS placebo plus GCAE. The treatments will be given twice weekly for 6 weeks. Pain intensity, physical function, health care utilization, and psychosocial function will be assessed with self-report and performance-based measures. These assessments will be conducted at study start, immediately after the last treatment session, and 6 months after study completion.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low back pain for at least 3 months
- •Able to walk without an assistive device (e.g., cane or walker)
排除标准
- •Serious underlying illness causing back pain
- •Nerve root compression
- •History of back surgery
- •Has pacemaker
- •Current use of blood thinners
- •Major psychiatric disorder
- •Chest pains or heart problems that interfere with daily activity
- •Fibromyalgia
研究组 & 干预措施
Lumbar PENS + exercise
Lumbar PENS twice a week for six weeks combined with general conditioning and aerobic exercise
干预措施: Lumbar PENS + General Conditioning and Aerobic Exercise (Other)
Lumbar PENS
Lumbar PENS twice a week for 6 weeks
干预措施: Lumbar PENS (Other)
Control PENS
Control lumbar PENS twice a week for 6 weeks
干预措施: Control Lumbar PENS (Other)
Control PENS + exercise
Control PENS twice a week for 6 weeks along with general conditioning and aerobic exercise
干预措施: Control PENS + exercise (Other)
结局指标
主要结局
Roland and Morris questionnaire
时间窗: Baseline, post-intervention, 6 months
次要结局
未报告次要终点