Brain Plasticity Underlying Back Pain Response to Different Acupuncture Methods
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Pain improvement in patients with lower back pain
研究概览
简要总结
Acupuncture has been used for many years to help relieve pain. However, it is not clear how acupuncture works. We are doing this study to learn about the effects of different forms of acupuncture on chronic low back pain. We are interested in learning about brain activity during pain. We plan to look at brain activity at the beginning and the end of the study, after 6 sessions of acupuncture.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers 18-60 years of age.
- •Meet the Classification Criteria of the 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 11-point LBP intensity scale.
- •Patients must be able to provoke or exacerbate their chronic LBP using our calibrated exercise-like maneuver.
- •Must have had a prior evaluation of their low back pain by a health care provider, which may have included radiographic studies. Documentation of this evaluation will be sought from Partners or outside medical records and kept in the subject's research record.
- •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. cancer, fractures, spinal stenosis, infections),
- •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 acupuncture intervention effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis).
- •Conditions making acupuncture difficult (e.g. paralysis, psychoses),
- •Prior acupuncture treatment for back pain; 1 year wait for any other type.
- •The intent to undergo surgery during the time of involvement in the study.
- •History of cardiac, respiratory, or nervous system disease that, in Dr. Wasan'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.
- •Involvement in workmen's compensation or disability claims.
- •Radicular pain extending below the knee.
- •Active substance abuse disorders within the last 24 months, based on subject self-report.
- •Use of more than 60 mg morphine equivalent prescription opioids or steroids for pain.
研究组 & 干预措施
Traditional Acupuncture
Participants will receive acupuncture over 6 30-minute sessions.
干预措施: Traditional Acupuncture (Procedure)
Laser Acupuncture
Participants will receive laser acupuncture over 6 30-minute sessions.
干预措施: Laser Acupuncture (Procedure)
Wait-List
Subjects will be put on a 6 week wait-list and receive vouchers for acupuncture at a local clinic.
结局指标
主要结局
Pain improvement in patients with lower back pain
时间窗: 6 weeks
Pain rating changes for chronic low back pain after acupuncture sessions.
次要结局
未报告次要终点
研究者
Robert Edwards
Principal Investigator
Brigham and Women's Hospital