Effect of Acupoint Application With Yanqing Zhitong Ointment for Chronic Non-specific Low Back Pain: a Non-inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- McGill pain questionnaire
研究概览
简要总结
This is a non-inferiority randomized controlled trial, recruiting 150 patients with chronic non-specific low back pain. The patients will be randomly assigned either to Yanqing Zhitong Ointment acupoint application group (Treatment Group) or the acupuncture group (Control Group) in a 1:1 ratio.
详细描述
This is a non-inferiority randomized controlled trial, 150 patients with chronic non-specific low back pain were randomly assigned to acupoint application group and acupuncture group in a 1:1 ratio. The main acupoints are Ashi points, Shenshu(BL23), Guanyuanshu(BL26). The primary outcome measure is the change of McGill Pain Questionnaire (MPQ) before and after treatment.
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
- Single (Outcomes Assessor)
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
- •Diagnosed with non-specific low back pain
- •Aage from 18 to 65
- •VAS between 4 and 7
- •No other treatment in the past 3 months
- •No other simultaneous relevant treatment
- •Voluntarily joining this study with informed consents
排除标准
- •Pregnant women
- •With skin ulcers or contusion wounds
- •Past history of severe allergy to transdermal preparations
- •Complicated with serious diseases
研究组 & 干预措施
Acupoint application with Yanqing Zhitong Ointment
Acupoint selection: Ashi points, Shenshu (BL23), Guanyuanshu (BL26) Operation: Stick to each acupoint for about 4 hours. If there is a burning sensation or obvious itching or other discomfort on the part after application, it can be removed in advance.
Treatment Duration: Three times a week( Monday, Wednesday, and Friday), for four weeks
干预措施: Yanqing Zhitong Ointment Acupoint application (Other)
Acupuncture
Acupoint selection: Ashi points, Shenshu (BL23), Guanyuanshu (BL26) Operation: Disposable stainless steel needles (0.25mm×25mm) are used. The needles are retained for 20 mins afte Deqi.
Treatment Duration: Three times a week( Monday, Wednesday, and Friday), for four weeks
干预措施: Acupuncture (Other)
结局指标
主要结局
McGill pain questionnaire
时间窗: Change from baseline to Week 4
MPQ is a multi-factor pain score scale, which establishes a three-dimensional structure of the nature of pain. MPQ has a higher evaluation dimension and can evaluate the multi-dimensional factors of pain. The higher the score, the more severe the pain.
次要结局
- Tenderness threshold(Change from baseline to Week 4 and Week 8)
- Item Short Form Health Survey (SF-36)(Change from baseline to Week 4 and Week 8)
- McGill pain questionnaire(Change from baseline to Week 8 (follow-up))
- Oswestry Dysfunction Index (ODI)(Change from baseline to Week 4 and Week 8)
研究者
ZhanYJ
Shanghai University of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine