NCT01614639已完成不适用
A Physiological fMRI Study of Acupuncture and Perceptions of Pain in Chronic Low Back Pain Patients.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Brain changes to acupuncture
研究概览
简要总结
We are doing this research study to learn about how acupuncture treatment works. This study is being done to look at changes in the brain, NOT to treat pain. We want to learn about brain activity during acupuncture. We will look at brain activity when a heating device touches the skin of a subject before and after the subject has acupuncture, to see what changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meet the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by the referring physician
- •At least 4/10 clinical pain on the 10-point LBP intensity scale on average during the past two weeks prior to enrollment
- •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
- •Must have had a prior evaluation of their low back pain by a health care provider, which may include radiographic studies. Documentation of this evaluation will be obtained from the subject's medical record
排除标准
- •Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections)
- •Radicular pain extending below the knee
- •Complicated back problems (e.g., prior back surgery, medicolegal issues)
- •Possible contraindications for acupuncture (e.g., coagulation disorders, cardiac pacemakers, pregnancy, seizure disorder), and conditions that might confound treatment effects or interpretation of results (e.g., severe fibromyalgia, rheumatoid arthritis)
- •Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator and/or a T score > 60 on the psychological measures assessed during Session 1)
- •Prior acupuncture treatment for back pain; 1 year minimum wait for any condition other condition.
- •Active substance abuse disorder in the past two years, as determined by subject self-report.
- •The intent to undergo surgery during the time of involvement 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 outcome. For example: asthma or claustrophobia.
- •Presence of any contraindications to MRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
- •Unresolved legal/disability/workers compensation claims in connection with low back.
- •Instability of pain ratings in Session 2 or Session
- •Use of more than 60 mg prescription opioids or steroids for pain.
结局指标
主要结局
Brain changes to acupuncture
时间窗: 3 visits
The effects of pain on the brain
次要结局
未报告次要终点
研究者
Robert Edwards
Investigator
Brigham and Women's Hospital
研究点 (2)
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