Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Proportion of responders
研究概览
简要总结
Lumbar disc herniation with radiculopathy (LDHR) is the local displacement of the intervertebral disc and its contents beyond the edge of the normal intervertebral disc space, resulting in pain, weakness or numbness in the muscle or dermatomal distribution area. Electroacupuncture is based on obtaining the needling sensation manually and applying electrical stimulation of different frequencies and intensities, aiming to enhance the intensity of acupoint stimulation to improve the effect. As a kind of acupoint stimulation therapy, electroacupuncture has shown analgesic effects in animal experiments. However, at present, the clinical evidence of electroacupuncture applied in the treatment of LDHR is still insufficient. Therefore, this randomized, single-blind, sham electroacupuncture controlled trial aims to evaluate the efficacy and safety of electroacupuncture as a treatment for LDHR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 18 to 70 years old.
- •With intervertebral disc protrusion confirmed by a MRI or CT, accompanied by radicular pain in the lower extremities.
- •With a NRS score ≥ 4 points for both low back pain and leg pain, and the pain lasts for at least 3 months;
- •Voluntarily participating the trial and signing the informed consent form.
排除标准
- •Previous surgical treatment of the spine.
- •Received any physical therapy for lumbar disc herniation within the recent 3 months.
- •Complicated with diseases that can cause low back and leg pain.
- •Symptomatic foraminal stenosis caused by severe degenerative diseases, accompanied by severe nerve injuries.
- •Previous severe mental illness, organ failure, or malignant tumor.
- •Planned spinal surgery or other major surgeries within the next 3 months.
- •Pregnancy or lactation.
结局指标
主要结局
Proportion of responders
时间窗: Weeks 8 and 24
Definition of a response: a reduction of at least 2 points in the score of the Numerical Rating Scale for both low back pain and leg pain.
次要结局
- Intensity of low back pain(Weeks 2, 4, 8, 16, and 24)
- Intensity of leg pain(Weeks 2, 4, 8, 16, and 24)
- Level of disability(Weeks 2, 4, 8, 16, and 24)
- Performance status(Weeks 2, 4, 8, 16, and 24)
- Severity of depression(Weeks 2, 4, 8, 16, and 24)
- Severity of anxiety(Weeks 2, 4, 8, 16, and 24)
- Sleep quality(Weeks 2, 4, 8, 16, and 24)
- Pain self-efficacy(Weeks 2, 4, 8, 16, and 24)
- Use of analgesics(Weeks 8 and 24)
- Incidence of lumbar spine surgery(Weeks 8 and 24)
- Incidence of any adverse events(Weeks 8 and 24)
- Incidence of treatment-related adverse events(Weeks 8 and 24)
- Incidence of serious adverse event(Weeks 8 and 24)
研究者
Xu Zhou
Professor
Jiangxi University of Traditional Chinese Medicine