Efficacy of Electroacupuncture Combined With Auricular Acupressure in Patients With Chronic Low Back Pain Due to Lumbar Spondylosis With Kidney Yin Deficiency Syndrome: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- The change of the Visual Analog Scale (VAS) Score
研究概览
简要总结
Chronic low back pain (CLBP) due to lumbar spondylosis is a leading cause of disability, significantly impacting the quality of life in middle-aged and elderly populations. While electroacupuncture (EA) and auricular acupressure (AA) are recognized as safe, non-pharmacological therapies, high-quality clinical evidence specifically evaluating their combined effects on CLBP patients with TCM "Kidney Yin deficiency" syndrome remains limited.This randomized controlled trial aims to evaluate the efficacy and safety of combining EA with AA (utilizing Vaccaria segetalis seeds) compared to EA combined with sham AA. The study will focus on 76 eligible patients at Le Van Thinh Hospital. Primary objectives are to measure changes in pain intensity (VAS) and functional improvement (ODI) at three intervals: baseline (T0), after 7 days (T1), and upon completion of the 14-day intervention (T2). The findings are expected to provide an evidence-based foundation for an integrated treatment approach to manage chronic lumbar pain effectively.
详细描述
76 eligible patients with CLBP due to lumbar spondylosis (Kidney Yin deficiency syndrome) will be enrolled in this study. Participants will be randomly assigned to either the experimental or control group using a computer-generated randomization list (Microsoft Excel 365) with a 1:1 allocation ratio. Allocation concealment will be ensured using opaque, sealed envelopes.
- The experimental group will receive 20 minutes of electroacupuncture combined with auricular acupressure at Shenmen (TF4), Subcortex (AT4), Lumbar spine (AH9), and Kidney (CO10) acupoints.
- The control group will receive 20 minutes of electroacupuncture combined with sham auricular acupressure at Anus (HX5), Shoulder (SF4), Lung (CO14), and Tooth (LO1) acupoints.
- Both groups will undergo interventions once a day, 5 times a week, for 2 weeks (total 10 sessions). Clinical outcomes including the Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and adverse events will be evaluated at baseline (T0), day 7 (T1), and day 14 (T2).
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)
盲法说明
Participants in both groups receive identical patches and seeds, differing only in acupoint locations to ensure blinding. Outcome assessors and data analysts are blinded to group assignments. The acupuncturist, who also performs the seed pressing instead of the participants, is not blinded.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 70 years.
- •Low back pain persisting for ≥ 12 weeks.
- •Pain intensity: 30 ≤ VAS ≤
- •Disability index: ODI ≥ 10%.
- •Diagnosed with Lumbar Spondylosis by a physician, supported by clinical signs (mechanical pain) and imaging (X-ray or MRI showing degeneration).
- •Diagnosed with Kidney Yin deficiency syndrome by a certified TCM physician, exhibiting symptoms such as: lower back/knee soreness, afternoon fever/hot flashes, night sweats, tinnitus, dry mouth, red tongue, or rapid/fine pulse.
- •Voluntary consent to participate.
排除标准
- •Contraindications to auricular acupressure (e.g., ear skin infection) or electroacupuncture (e.g., pregnancy, severe heart failure, surgical indications, pacemakers, metal implants).
- •Specific causes of low back pain (e.g., infection, tumor, osteoporosis, ankylosing spondylitis, fracture).
- •Disc herniation with surgical indications (e.g., muscle atrophy, severe limb weakness, or sphincter dysfunction).
- •Currently participating in other interventional studies.
- •Currently taking medications that may affect study outcomes (painkillers, muscle relaxants, antidepressants, TCM drugs).
研究组 & 干预措施
Experimental Group
Electroacupuncture + Auricular Acupressure
干预措施: Electroacupuncture (Device)
Experimental Group
Electroacupuncture + Auricular Acupressure
干预措施: Auricular Acupressure (Device)
Sham Comparator Group
Electroacupuncture + Sham Auricular Acupressure
干预措施: Electroacupuncture (Device)
Sham Comparator Group
Electroacupuncture + Sham Auricular Acupressure
干预措施: Sham Auricular Acupressure (Device)
结局指标
主要结局
The change of the Visual Analog Scale (VAS) Score
时间窗: Assessments are conducted before intervention and after each intervention week: Baseline (T0), Day 7 (T1), and Day 14 (T2).
Change in Pain Intensity measured by the Visual Analog Scale (VAS) Pain intensity will be assessed using a Visual Analogue Scale (VAS). It consists of a 100 mm horizontal line, without graduations, anchored at each end by descriptors: "0 mm" indicating "no pain" and "100 mm" indicating "worst possible pain". Pain Classification: Patients will be classified into 4 categories based on their measured VAS scores: 0 mm (No pain), 1 - 30 mm (Mild pain), 31 - 70 mm (Moderate pain), and 71 - 100 mm (Severe pain, including very severe and worst possible pain).
次要结局
- The change of the Oswestry Disability Index (ODI) percentage(Assessments are conducted before intervention and after each intervention week: Baseline (T0), Day 7 (T1), and Day 14 (T2).)
- Incidence of intervention-related adverse events(Monitored continuously throughout the 14-day intervention period.)
研究者
Nguyen Le Viet Hung
MD, PhD
University of Medicine and Pharmacy at Ho Chi Minh City