Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Low Back Pain Intensity
研究概览
简要总结
This proposal aims to investigate the treatment effect and underlying mechanism of transcutaneous acupuncture stimulation on chronic low back pain. We believe that this study, if successful, will provide new treatment options for chronic low back pain, reduce the use of opioid analgesics in chronic pain management, and enhance our understanding of the underlying mechanism of nerve stimulation treatment, as well as the pathophysiology and development of chronic pain.
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, Investigator)
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
- •Volunteers 18-65 years of age.
- •Meet the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by a referring physician.
- •Received stable treatment or no treatment in the past month.
- •At least a 10th grade English-reading level. English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.
排除标准
- •Specific causes of back pain (e.g., epidural abscess, compression fracture, spondyloarthropathy, malignancy, cauda equina syndrome) or radicular pain, radiculopathy, or spinal canal stenosis. Complicated back problems (e.g., prior back surgery, medico-legal issues).
- •Presence of headache/migraine, as well as widespread body pain such as fibromyalgia.
- •The intent to undergo surgery during participation in the study.
- •History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcomes (e.g., asthma or claustrophobia).
- •Presence of any contraindications to MRI scanning (e.g., cardiac pacemaker, metal implants, fear of enclosed spaces, pregnancy, cannot lie still in fMRI scanner).
- •Conditions that might confound longitudinal effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis).
- •Pregnant or lactating.
- •Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1).
- •Active substance abuse disorders within the last 24 months (based on subject self-report).
- •Use of prescription steroids for pain during the past six months.
- •Presence of any other acute or chronic pain disorder.
- •Any medical conditions, such as peripheral neuropathy, that could affect the results of QST.
研究组 & 干预措施
Ear stimulation (Location 1)
干预措施: Stimulation at Location 1 (Other)
Ear stimulation (Location 2)
干预措施: Stimulation at Location 2 (Other)
结局指标
主要结局
Low Back Pain Intensity
时间窗: 1 month
This is a uni-dimensional measure of chronic low back pain intensity. It uses an 11-point numeric scale (0 indicate no pain, and 10 indicates max level of pain that can be imagined). We will use it to measure the patient's average pain intensity in the past week, which will be measured at the beginning and end of the study.
次要结局
- Roland-Morris Disability Questionnaire Score(1 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Scores(baseline and post-treatment)
- Pain Catastrophizing Scale(baseline and post-treatment)
- The Pennebaker Inventory of Limbic Languidness(Baseline)
- Resting State Functional Connectivity Changes of the PAG(1 month)
研究者
Jian Kong
Physician
Massachusetts General Hospital