Efficacy and Safety of Acupuncture for Degenerative Lumbar Spinal Stenosis: Protocol for a Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The change of Modified Roland-Morris Disability Questionnaire (RMDQ) from baseline.
研究概览
简要总结
Degenerative Lumbar spinal stenosis (DLSS) is a major problem for public health and the primary reason the older seek lumbar spine surgery. Acupuncture is safe and maybe effective for DLSS but the evidence is poor. Therefore, an objective assessment of acupuncture efficacy is critical for making informed decisions about its appropriate role for patients. A total of 80 participants meet prior inclusion criteria will be recruited. The participants will be allocated to acupuncture group or placebo needle (unpenetrated acupuncture) group randomly. Twenty-four treatments will be provided over 8 weeks. The primary change of Modified Roland-Morris Disability Questionnaire (RMDQ) and secondary outcomes including the change of Number Rating Scale (NRS); the change of Self-paced Walking test (SPWT); the change of Swiss Spinal Stenosis Questionnaire (SSSQ); the expectations that acupuncture might help participants with DLSS. All outcomes will be assessed at baseline, and/or after 4, 8, 20 and 32 weeks. Statistical analysis will include independent sample t-test, Chi-squared test and non-parametric test. The investigators hope the result of this trial will clarify the value of acupuncture for DLSS and help clinicians make proper decisions.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who meet all of the following conditions will be considered for enrollment. The inclusion criteria are as follows:
- •Pain in the low back, buttock, and/or lower extremity with standing, walking and/or spinal extension. (Using NRS questionnaire to measure pain symptoms, and pain measured by NRS ≥ 4.)
- •Roland-Morris score of at least
- •Mild-moderate-severe lumbar central canal spinal stenosis identified by MRI or CT scan.
- •Lower extremity symptoms consistent with neurogenic claudication.
- •Age 50 to 80 years old.
- •Signed the consent and take part in this trial of his/her willing.
排除标准
- •Congenital stenosis of vertebral canal, serious indications of DLSS (such as segmental muscular atrophy, bowel and bladder disturbances), spinal nerve root canal stenosis, lumbar spondylolysis, lumbar tuberculosis, lumbar vertebral tumors, and vertebral body compression fracture.
- •Spinal instability requiring surgery.
- •Severe vascular, pulmonary or coronary artery disease that limits ambulation including recent myocardial infarction.
- •Participants who have cognitive impairment that may render the subject unable to give informed consent or provide accurate data.
- •Clinical co-morbidities that could interfere with the collection of data concerning pain and function.
- •Acupuncture within the past 30 days.
- •Administered pain control drugs during the week prior to the baseline assessment (e.g.,non-steroidal anti-inflammatory drugs or herbal anti-inflammatory agents).
研究组 & 干预措施
Acupuncture group
Acupuncture has a long time used for chronic pain including low back pain, sciatica, and other pain related to spina via stimulating specific acupuncture points.
干预措施: acupuncture (Device)
Placebo needle group
The placebo needle using in this trial will be unpenetrated needles. Based on our previous research, the placebo needle is a valid control for acupuncture research and may eliminate the placebo effect of acupuncture.
干预措施: placebo needle (Device)
结局指标
主要结局
The change of Modified Roland-Morris Disability Questionnaire (RMDQ) from baseline.
时间窗: Baseline, week 1-4, week 5-8, week 9-20, week 21-32
次要结局
- The change of Number Rating Scale (NRS) from baseline.(Baseline, week1-8, week 9-20, week 21-32)
- The change of Self-paced Walking test (SPWT) from baseline to week 8.(Baseline, week 8.)
- The change of Swiss Spinal Stenosis Questionnaire (SSSQ) from baseline.(Baseline, week 1-4, week 5-8, week 9-20, week 21-32)
- The expectations that acupuncture might help patients DLSS will be recorded at baseline (scale).(Baseline.)
研究者
Qin Zongshi
Dr.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences