Electroacupuncture for Sciatica Due to Intervertebral Disc Displacement
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Visual Analog Scale(VAS) of Leg Pain
研究概览
简要总结
This multicenter randomized controlled trial (RCT) will evaluate the therapeutic effectiveness and health-economics of electroacupuncture for sciatica due to intervertebral disc displacement in 3 compared groups: electroacupuncture, electroacupuncture plus traction, electroacupuncture plus traction and medication.
详细描述
This is a multicenter RCT with 3 groups to determine the effectiveness and health economic evaluation of the electroacupuncture for sciatica due to intervertebral disc displacement in a population of adults aged 18-65. 324 participants who meet the inclusion criteria will be randomly allocated into 3 different groups, namely electroacupuncture group, electroacupuncture & traction group, electroacupuncture & traction & oral medication group.
All participants will receive six-week treatment, the participants in electroacupuncture group will receive electroacupuncture only, electroacupuncture & traction group will receive both electroacupuncture and traction, and in electroacupuncture & traction & oral medication group all of the three therapies are adopted.
The statistical analysis will be conducted by a third party who is masked to the allocation of participants.
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
- •Patients who meet the clinical diagnosis of sciatica caused by intervertebral disc displacement;
- •Male or female, aged 18-65;
- •Have completed informed consent form.
排除标准
- •Patients with sciatica caused by diseases such as piriformis syndrome, thickening of ligamentum flavus, acute lumbar strain, contusion, congenital spina bifid, lumbar and sacrum deformity, lumbar sacral vertebra joint disorder or proliferative osteoarthrosis;
- •Patients with urinary and fecal incontinence caused by acute lumbar disc herniation, huge or central type lumbar disc herniation sufferer in need of surgery;
- •Patients who fail to finish the basic treatment course, or have poor adherence;
- •Patients having a poor state, particularly unconsciousness, psychopath, severe osteoporosis, concurrent infection or bleeding susceptibly, or accompany with primary diseases in cardiovascular, digestion or hemopoietic systems and viscera as kidney, liver;
- •Pregnant or lactating women;
- •Patients in other clinical research.
研究组 & 干预措施
Electroacupuncture (EA)
Use Electroacupuncture only
干预措施: Electroacupuncture (EA) (Other)
EA + Traction
Use electroacupuncture and traction together
干预措施: Electroacupuncture (EA) (Other)
EA + Traction
Use electroacupuncture and traction together
干预措施: Traction (Other)
EA + Traction + Oral Medication
Combine electroacupuncture, traction and oral medication (Voltaren and Vitamin B1) together for treatment
干预措施: Traction (Other)
EA + Traction + Oral Medication
Combine electroacupuncture, traction and oral medication (Voltaren and Vitamin B1) together for treatment
干预措施: Electroacupuncture (EA) (Other)
EA + Traction + Oral Medication
Combine electroacupuncture, traction and oral medication (Voltaren and Vitamin B1) together for treatment
干预措施: Voltaren (Drug)
EA + Traction + Oral Medication
Combine electroacupuncture, traction and oral medication (Voltaren and Vitamin B1) together for treatment
干预措施: Vitamin B1 (Drug)
结局指标
主要结局
Visual Analog Scale(VAS) of Leg Pain
时间窗: Change from baseline in VAS of Leg Pain at 6 weeks
次要结局
- The Medical Outcomes Study 36-Item Short -Form Health Survey Questionnaire (SF-36)(Change from baseline in SF-36 at 6 weeks)
- Sciatica Frequency and Bothersome Index (SFBI)(Change from baseline in SFBI at 6 weeks)
- Visual Analog Scale(VAS) of Low Back Pain(Change from baseline in VAS of Low Back Pain at 6 weeks)
- Simplified McGill Pain Questionnaire (ST-MPQ)(Change from baseline in ST-MPQ at 6 weeks)
- Improved Roland Functional questionaire(RDQ)(Change from baseline in RDQ at 6 weeks)
- Likert Overall Recovery Self Rating Scale (7 points)(Change from baseline in Likert Overall Recovery Self Rating Scale at 6 weeks)
研究者
Wu Xi
Principal Investigator
Chengdu University of Traditional Chinese Medicine