Acupuncture on GB26 to Treat Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 114
- 主要终点
- Change in Numerical Rating Scale (NRS) score
研究概览
简要总结
This study evaluates the effecacy of acupoint GB26 based acupuncture treatment in patients with chronic low back pain. Half of the participants will partake in a 2-week acupuncture intervention, while the other half will receive a placebo treatment. The investigators hypothesize that acupuncture on GB26 reduces disability and pain more than the control intervention.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (both male and female) with non-specific low back pain for more than three months.
- •Age range: between 20 and 60 years.
- •Willingness of the patient to participate in the study, and written informed consent signed and personally dated by the patient.
- •Chronic non-specific low back pain clinically diagnosed as repeated lumbar sourness and swelling pain or a chronic progressive process, accompanied by (i) X-ray examination to exclude lumbar vertebrate fractures, spondylolysis, spondylolisthesis and severe osteoporosis, and/or (ii) MRI with normal signal or low nucleus pulposus signal.
排除标准
- •Age less than 20 or greater than 60 years
- •Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections)
- •Complicated back problems (e.g., prior back surgery, medico-legal 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 treatment difficult (e.g., paralysis, psychoses, or other severe psychiatric problems based on the judgment of a physician investigator and/or a T score >60 on the psychological assessments performed during Session 1)
- •Prior acupuncture treatment for back pain; 1 year minimum for any other condition.
- •The intent to undergo surgery during the time of involvement in the study.
- •History of cardiac, respiratory, or nervous system disease that, in the judgment of a physician investigator, precludes participation in the study because of a heightened potential for adverse outcome (e.g., asthma, claustrophobia)
- •Presence of any contraindications to MRI scanning (e.g., cardiac pacemaker, metal implants, fear of closed spaces, pregnancy)
- •Active substance abuse disorders within the last 24 months, based on subject self-report
- •Radicular knee pain extending below the knee
研究组 & 干预措施
Deep acupuncture on GB26
干预措施: acupuncture (Other)
Superficial acupuncture on GB26
干预措施: acupuncture (Other)
waiting list
结局指标
主要结局
Change in Numerical Rating Scale (NRS) score
时间窗: Change from baseline NRS score at 1 weeks, 2 weeks, 4 weeks and 12 weeks
The NRS will ask patients to rate their pain intensity on an 11-point scale where 0 indicates no pain and 10 indicates worst imaginable pain
Change in Oswestry Low Back Pain Disability Questionnaire (OLDPDQ) score
时间窗: Change from baseline NRS score at 1 weeks, 2 weeks, 4 weeks and 12 weeks
The OLDPDQ score is considered the 'gold standard' of low back functional outcome tools. The questionnaire is composed of ten sections (addressing pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling); for each section the possible score is 5 and, thus, the total possible score is 50. The final score is calculated as \[(sum of individual scores) / 50\] \*100 (%), and is interpreted as minimal disability (0% to 20%), moderate disability (21% to 40%), severe disability (41% to 60%), crippled (61% to 80%) or patients are either bed-bound or exaggerating their symptoms (81% to 100%).
次要结局
未报告次要终点
研究者
Tang Lewei
Principal Investigator
Wenzhou Medical University