Evaluation of Electro-acupuncture - induced Autonomic function in relation to treatment duration among patients with Acute Non-specific Low Back Pain - A Two Arm Clinical Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- HRV
研究概览
简要总结
Electro-acupuncture works by stimulating specific acupuncture points, activating sympathetic nerve fibers, and increasing endogenous opioids, which help reduce pain and inflammation. Treatment durations of 20 and 40 minutes have been shown to effectively reduce pain. By targeting acupuncture points UB-25 and UB-26 with electro-acupuncture, along with GV-4 through normal acupuncture, this treatment aims to enhance autonomic nervous system function, alleviate pain, and promote healing. Increased parasympathetic activity is expected as part of the therapeutic effect, contributing to pain relief and improved healing. The study will compare the efficacy of these two time intervals in providing pain relief and improving autonomic function in patients with acute NSLBP.
This study aims to explore the effects of electro-acupuncture on acute non-specific low back pain (NSLBP). A total of 60 participants will be randomly assigned to two groups, each consisting of 30 individuals. Arm 1 will receive electro-acupuncture with electrical stimulation at UB-25 and UB-26 for 20 minutes, along with normal acupuncture at GV-4, while Arm 2 will undergo the same treatment for 40 minutes. The primary measures for assessing baseline and outcomes will include heart rate variability (HRV) and Algometry, both of which will be recorded before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •The study includes individuals aged 18 years and older who have non-radicular low back pain, restricted to the area above the knee or experiencing somatically referred pain only.
- •Participants must not have received any acupuncture or related therapy in the 7 days prior to study entry.
- •Informed consent must be signed, and participants should score more than 3 on the Visual Analog Scale (VAS) during screening to be eligible for the study.
排除标准
- •The study excludes individuals under the age of eighteen and those with low back pain caused by factors such as tumors, infections, metabolic conditions, inflammatory arthritis, or fractures.
- •Participants with recognized abnormalities, including scoliosis, spondylolisthesis, or spondylolysis, as well as those experiencing pain below the knee or associated with conditions unrelated to the spine (e.g., visceral, vascular, or genito-urinary causes) are also excluded.
- •Individuals who have previously undergone lumbar surgery, have nervous system impairments, or experience back pain linked to multiple areas of extensive multi-site discomfort are not eligible.
- •Additionally, pregnant or lactating women, those who have used any form of acupuncture in the 7 days prior to study entry, individuals with implanted medical devices such as pacemakers, and patients with a known allergy to acupuncture needles or electroacupuncture materials are also excluded from the study.
结局指标
主要结局
HRV
时间窗: 20 minutes and 40 minutes
次要结局
- Algometry(20 minutes and 40 minutes)
研究者
Dr Jebalin Josco J
International Institute Of Yoga And Naturopathy Medical Sciences, Chengalpattu