Predicting Analgesic Response to Acupuncture: A Randomized, Placebo-Controlled, Subject and Assessor Blinded, 100-Subject Clinical Trial of Electro-Acupuncture in the Treatment of Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Roland Morris Disability Questionnaire
研究概览
简要总结
In this placebo controlled, patient and assessor blinded clinical trial, the investigators will administer electroacupuncture vs sham electroacupuncture to patients suffering from chronic low back pain, and monitor their symptoms as well as collecting objective outcome measures. The investigators objective is to identify predictors of pain reduction and functional improvement with electroacupuncture vs placebo.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English Fluency
- •Chronic LBP for ≥ 6 Months
- •Chronicity: cLBP "defined as a back pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months."
- •Location: "between the lower posterior margin of the rib cage and the horizontal gluteal fold
- •Average pain over the last month ≥ 5/10
排除标准
- •Radicular low back pain: defined as sharp (or burning) pain, with a defined territory, radiating down the limb, beyond the knee. Radicular pain may be accompanied by sensory and motor deficit along 1 or more dermatomes. Radicular back pain may also be accompanied by MRI evidence of intervertebral disc protrusion and compression of spinal cord and/or nerve roots.
- •Pending litigation or Worker's compensation related to the low back pain.
- •Currently pregnant or planning to become pregnant (in next 6 months)
- •American Society of Anesthesiologist (ASA) class III or above physical status. ASA class III is defined as "a patient with severe systemic disease." Examples would include poorly controlled diabetes, hypertension, COPD or morbid obesity (BMI ≥ 40).
- •Mental health conditions or treatment for mental health problems that would interfere with study procedures, at the discretion of the study team. For example, psychosis, untreated major depression, ongoing substance abuse, suicidal ideation. These will be assessed by the MINI.
- •Medications: opioids ≥60mg morphine equivalent units/day, benzodiazepines, corticosteroids.
- •Prohibited interventions: during the study period, the following are not permitted
- •Back surgeries
- •Injections with local anesthetics or steroids to the back
- •New chiropractic maneuvers
- •New physical therapy programs
- •New medications for back pain
- •Bleeding disorders at the discretion of the study team.
- •Previous acupuncture treatment in the past 10 years.
- •Medical conditions that would interfere with study procedures (eg. Heart disease or pacemaker, active infection), per discretion of the team
研究组 & 干预措施
Verum Electroacupuncture
Active Intervention
干预措施: Real Acupuncture with Electrical Stimulation (Other)
Placebo Electroacupuncture
Validated Control
干预措施: Simulated Acupuncture with Electrical Stimulation (Other)
结局指标
主要结局
Roland Morris Disability Questionnaire
时间窗: 1 day
Validated functional outcome measure in chronic low back pain with 24 yes/no questions regarding physical function.
Mean back pain intensity by patient-report
时间窗: 7 days
Patient self-reported mean back pain intensity on 11 point (0-10) numerical rating scale (NRS).
次要结局
- Heart Rate Variability(1 month)
- Quantitative Sensory Testing(Tests used are typically stable for 1-2 weeks)
- Physical exam to determine neurological function(1 month)
- Physical exam to assess lumbar spine range of motion(1 month)
- Blood pressure(1 day)
- Physical exam to assess lumbar facet irritation.(1 month)
研究者
Jiang-Ti Kong
Principal Investigator, Instructor - Department of Anesthesia, Pain and Perioperative Medicine
Stanford University