Efficacy of Acupuncture for Discogenic Sciatica: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- change from baseline in mean weekly VAS of leg pain
研究概览
简要总结
This trial is designed to evaluate the efficacy of acupuncture on pain relief for patients with discogenic sciatica compared with sham acupuncture.
详细描述
Background: Sciatica is primarily caused by herniated discs with nerve-root compression. Acupuncture may effectively relieve the pain of discogenic sciatica, but the evidence is limited.
Methods/Design: Sixty patients with discogenic sciatica will be recruited and randomized to receive acupuncture or sham-acupuncture at a 1:1 ratio. Patients in both groups will receive treatment 3 times per week for 4 weeks. The following acupoints will be used: Dachang shu (BL 25), Shenshu (BL 23), Weizhong (BL 40), and Chengshan (BL 57).
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral leg pain diagnosed as discogenic sciatica;
- •Sciatica patients with an average leg pain VAS of 40 mm or higher in the last 24 hours;
- •Aged 18 to 75 years;
- •Leg pains that correlate with CT or MRI findings of lumbar disc herniation;
- •Patients who agree to follow the trial protocol.
排除标准
- •Severe cases with central or giant or ruptured lumbar disc herniation, cauda equina syndrome, foot drop, or surgery requirements;
- •Progressive neurological symptoms after 3 months of strict conservative treatment (e.g., nerve root adhesion, crossed straight-leg testing, or obvious muscle atrophy);
- •Severe cardiovascular, liver, kidney, hematopoietic system diseases, autoimmune diseases, or poor nutritional status;
- •Subjects with cognitive impairment;
- •Subjects who received acupuncture for sciatica within the past month.
研究组 & 干预措施
Acupuncture
Shenshu (BL23) on bilateral sides and Dachangshu (BL25), Weizhong (BL40), and Chengshan (BL57) on the affected side will be applied.
Huatuo Brand needle (0.3*75 mm) will be used for BL25 and Huatuo Brand needle (0.3*40mm) will be used for BL23, BL40 and BL57.
干预措施: Acupuncture (Procedure)
Sham acupuncture
The acupoints will be the same as the acupuncture group. Specially designed sham needles (0.3*25 mm) will be used . The sham needle consists of a needle handle, needle body, blunt tip and a sterile polyethylene cylindrical foam pad (identical to the pads in the acupuncture group).
干预措施: Sham acupuncture (Procedure)
结局指标
主要结局
change from baseline in mean weekly VAS of leg pain
时间窗: Baseline, weeks 1-4, week 16 and week 28
VAS uses a 100-mm line that is labeled at each end, and 0 mm represents no pain, and 100 mm represents unbearable pain. Patients will rate the VAS (average VAS of leg pain in the past 24 hours), and a researcher will record the VAS once weekly, generally at the third weekly treatment. The mean weekly VAS of leg pain over weeks 1-4 will be calculated as the sum VAS of each week divided by the number of weeks assessed.
次要结局
- Change in mean weekly VAS of low back pain(Baseline, weeks 1-4, week 16 and week 28)
- Oswestry disability index(Baseline, week 4, week 16 and week 28)
- Patients' global impressions of improvement(week 4)
- Patients' expectations for acupuncture(baseline)
- Blinded evaluation(week 4)
- Incidence of serious adverse events(up to 28 weeks)
研究者
Qin Yao
Postgraduate
Guang'anmen Hospital of China Academy of Chinese Medical Sciences