A Randomized Control Trail: Evaluation of the Pain Relief Effect of Battlefield Acupuncture on Patients With Chronic Low Back Pain Due to Lumbar Spine Degeneration.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Visual Analog Scale
研究概览
简要总结
The Global Burden of Disease's 2023 study shows that lower back pain affects over 619 million people worldwide, with projections reaching 843 million by 2050. It is a common symptom of lumbar spine degeneration, with 84.2% of patients experiencing it. To address this issue, Vietnam's Ministry of Health has released guidelines on "Lumbar Spine Pain" (Yêu thống), combining traditional and modern medicine, including acupuncture, to alleviate pain. However, to achieve better treatment outcomes, the combination of multiple interventions, such as different types of acupuncture, is required. Additionally, the USAF's Integrative Medicine and Acupuncture Center released guidelines in 2021 for Battlefield Acupuncture (BFA), a rapid, safe, and effective pain relief method. Internationally, there are studies on BFA for various types of pain, including lower back pain, but none in Vietnam. Therefore, the investigators conducted this study to evaluate the effects of BFA combined with electroacupuncture and pain medication on chronic lower back pain patients with lumbar spine degeneration in Vietnam.
详细描述
The Global Burden of Disease's 2023 study shows that lower back pain affects over 619 million people worldwide, with projections reaching 843 million by 2050. It is a common symptom of lumbar spine degeneration, with 84.2% of patients experiencing it. To address this issue, Vietnam's Ministry of Health has released guidelines on "Lumbar Spine Pain" (Yêu thống), combining traditional and modern medicine, including acupuncture, to alleviate pain. However, to achieve better treatment outcomes, the combination of multiple interventions, such as different types of acupuncture, is required. Additionally, the USAF Integrative Medicine and Acupuncture Center published a guideline in 2021 for BFA ear acupuncture, specifying points to be acupunctured in the following order: Cingulate gyrus, Subcortex, Omega 2, Shen Men, and Zero. Currently, this method has been extensively researched and has shown its potential in both acute and chronic pain, such as chronic musculoskeletal pain in cancer patients, acute back pain in intensive care units, and non-specific chronic back pain. Despite the proven effectiveness in many studies and the publication of detailed guidelines for BFA in the USA, this potential pain relief method has not been evaluated for effectiveness in Vietnam. Therefore, the investigators conducted this study to evaluate the effects of BFA combined with electroacupuncture and pain medication on chronic lower back pain patients with lumbar spine degeneration in Vietnam.
The investigators conduct a single blind randomized control trail, from March 2025 to October 2025, on 60 low-back-pain patients diagnosed with lumbar spine degeneration (or lumbosacral spondylosis). These patients will be randomly divided into two groups: A (intervention group - 30 patients) and B (sham group - 30 patients). The patients in group A will receive ear acupuncture, while the patients in group B will receive sham ear acupuncture. All patients will be treated with electroacupuncture and prescribed pain medication. Each patient will undergo a 10-day course of treatment (3 sessions per week, each session 1 day apart from the previous one). The details of the intervention will be discussed further below. At the end of each session, the investigators will collect Visual Analog Scale (VAS) scores, and the number of pain medications used. At the end of the 5th and the 10th session, the investigators will collect Brief Pain Inventory (BPI) scores.
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 (Participant)
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20 years and older.
- •Patients diagnosed with lumbar spine degeneration (Imaging and clinical criteria according to the "Guidelines for Diagnosis and Treatment of Musculoskeletal Diseases" - Ministry of Health of Viet Nam 2014; AAFP-2024).
- •Patients with back pain with a VAS score of ≥ 50mm, continuous or recurrent with the same initial diagnosed cause, lasting from the time of initial diagnosis to the time of study participation for ≥ 3 months.
- •Individuals who have never used auricular acupuncture.
- •Voluntarily agree to participate in the study.
排除标准
- •Individuals with cognitive disorders (Glasgow < 13 points).
- •Individuals are allergic to any component of the ear acupressure seeds, or experiencing anxiety, fear of needles, or with a history of acupuncture syncope.
- •Patients with symptoms of saddle anesthesia, urinary or fecal incontinence, paresthesia or muscle atrophy, progressive muscle weakness.
- •History of cancer or currently undergoing cancer treatment, or unexplained weight loss.
- •Patients who are awakened at night due to back pain.
- •Patients contraindicated the medication used in the study: paracetamol.
- •Pregnant or breastfeeding women.
- •Patients are currently experiencing systemic infection.
- •Individuals with unhealed wounds, ear or lumbar region infections.
- •Currently participating in an intervention study with another drug or device.
研究组 & 干预措施
Experiment
Auricular acupuncture + Electro acupuncture + Pain medication
干预措施: Ear acupuncture (Device)
Experiment
Auricular acupuncture + Electro acupuncture + Pain medication
干预措施: Electro-acupuncture (Device)
Experiment
Auricular acupuncture + Electro acupuncture + Pain medication
干预措施: Paracetamol 500 mg (Drug)
Sham Comparator
Sham ear acupuncture + Electro acupuncture + Pain medication
干预措施: Electro-acupuncture (Device)
Sham Comparator
Sham ear acupuncture + Electro acupuncture + Pain medication
干预措施: Sham ear acupuncture (Device)
Sham Comparator
Sham ear acupuncture + Electro acupuncture + Pain medication
干预措施: Paracetamol 500 mg (Drug)
结局指标
主要结局
Visual Analog Scale
时间窗: Baseline, during procedure
The Visual analog scale is a continuous scale consisting of a horizontal line (HVAS) or a vertical line (VVAS), typically 10 cm (100 mm) in length. The scale is usually anchored at both ends with the descriptors "no pain" (score 0) and "worst imaginable pain" (score 100 \[100 mm scale\]). To avoid clustering scores around a preferred number, intermediate points should not be numbered or verbally described. The timing of data collection varies between different studies or examinations, but most respondents are asked to report pain intensity "currently" or pain intensity "in the past 24 hours."
Brief Pain inventory
时间窗: Baseline, session 1st, session 5th, session 10th
The BPI is a self-assessment scale for sensory aspects and responses to pain. The scale includes two parts: pain intensity and the degree of impact on various aspects of life. The impact is assessed in different areas of daily living such as sleep, mobility, and emotional well-being. The survey period can be either 7 days or 24 hours. IMMPACT (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials) recommends that BPI be used for clinical trials with patients suffering from chronic pain. BPI begins with a screening question about the location of the pain that the patient feels needs attention. The main sections include pain intensity scale and the impact of pain. A numerical rating scale from 0 to 10 is used for all items. The endpoints for the pain intensity scale are 0 = 'no pain' and 10 = 'pain as bad as you can imagine', while the endpoints for the quality-of-life scale are 0 = 'no impact' and 10 = 'total impact'.
Pain medication used
时间窗: During procedure
The use of pain medications serves as an indicator of the efficacy of acupuncture as a pain-relief intervention. An increased dependence on analgesic medications among patients signifies a diminished therapeutic effect of acupuncture in alleviating pain symptoms.
次要结局
未报告次要终点
研究者
Bui Pham Minh Man
Doctor of Philosophy
University of Medicine and Pharmacy at Ho Chi Minh City
