The Efficacy and Safety of Electroacupuncture Compared With Sham Acupuncture in Patients With Discogenic Low Back Pain: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
Low back pain (LBP) is a prevalent clinical condition characterized by pain localized between the lower edge of the 12th rib and the gluteal fold.The incidence of LBP has been escalating annually.An epidemiological survey encompassing 204 countries and territories globally projects a stark increase in the affected population, from an estimated 619 million in 2020 to a projected 843 million by 2050.LBP can affect individuals across all age groups, with a lifetime prevalence ranging from 60% to 80%, significantly impairing quality of life. Discogenic low back pain (DLBP), attributed to degenerative changes in the intervertebral discs, is the predominant subtype of LBP, comprising approximately 39% of all LBP cases. Disc degeneration typically initiates in early adulthood and progresses with age, potentially leading to DLBP.As the population ages, DLBP has emerged as a major contributor to disability worldwide, imposing a substantial burden on both individuals and society. Current international guidelines establish the foundation for surgical and pharmacological interventions for DLBP.However, considering the adverse effects and economic implications associated with surgical and medical treatments, there is a growing inclination towards recommending non-pharmacological therapies.These include physiotherapy, self-management, and psychotherapy, with a concurrent reduction in emphasis on pharmacological and surgical options.
Acupuncture and moxibustion are integral components of traditional Chinese medicine, garnering global recognition for their role in restoring the equilibrium of yin and yang within the human body . Electroacupuncture, a modern derivation of traditional acupuncture, has been extensively applied worldwide for the management of various painful conditions, including headache, myofibromyalgia, neck pain, and cancer-related pain. Despite its broad application, a limited number of clinical efficacy and safety studies have been conducted on electroacupuncture for the treatment of discogenic low back pain (DLBP), thereby necessitating a scientific foundation for its therapeutic use .
The present study aims to investigate the clinical efficacy and safety of electroacupuncture in the treatment of DLBP using an evidence-based medical approach. By employing a multicenter, randomized, and sham-controlled study design, this investigation seeks to provide a robust evidence-based medical foundation for the use of electroacupuncture in DLBP treatment.
Participants will be randomly assigned to either the acupuncture group (experimental group) or the sham acupuncture group (control group) in a 1:1 ratio, akin to a lottery drawing. Following enrollment, participants will undergo a 4-week, 12-session intervention, followed by three follow-up visits at 4, 12, and 24 weeks post-treatment. The investigators will assess participants' low back pain, lumbar spine function, and quality of life through telephone communication or on-site questioning at these designated follow-up intervals.
Needling may result in minor bleeding, pain, or hematoma at the needle site, and rare infections or allergic reactions may occur. Adverse reactions to needling, such as dizziness or nerve damage, are exceedingly rare.
Participants in this study may confer direct medical benefits, such as remission of symptoms, or may not, with outcomes ranging from no remission to potential exacerbation of the condition . However, the knowledge gained from this study is anticipated to benefit future people with similar conditions .
In addition to this study , participations may opt for treatment with modern rehabilitation medicine modalities or medications, including shortwave therapy, intermediate frequency therapy, or oral analgesics . This study would not impose any costs beyond the participants' regular medical treatment, and the investigators will cover all study-related medical expenses (including acupuncture treatment costs, needle costs, and scale evaluation costs) . The investigators are legally committed to maintaining the confidentiality of the participants' study records.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, outcome assessors, and statisticians were blinded.
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
- •It meets the diagnostic criteria of discogenic low back pain
- •Betweening 18 and 70 years of age (both 18 and 70) and of either sex
- •Visual analog score (VAS) for low back pain ≥40 mm within the last 1 month
排除标准
- •Patients with symptoms such as lower limb numbness, weakness and claudication as shown by lumbar disc herniation pressing the spinal nerve on imaging
- •Lumbar tuberculosis, tumor, infection, spinal fracture, lumbar spondylolisthesis, severe osteoporosis
- •Patients with a history of spinal and intervertebral disc surgery
- •Patients with rheumatism, rheumatoid disease, systemic lupus erythematosus, hematopoietic system, endocrine system and psychiatric diseases
- •Patients who have received radiofrequency, minimally invasive, ozone, small needle-knife, acupuncture, manipulation, traction, block therapy and other clinical trials within the last 1 month
- •Patients with severe needle fainting intolerance
- •Women who are pregnant, planning pregnancy or breastfeeding
- •People with a history of opioid analgesics, sedatives and hypnotics and alcohol abuse
- •Patients who plan to undergo acupuncture, massage, traction and other treatments related to this disease and other clinical research trials within 3 months of participating in the study
- •Patients with skin damage or infection, concomitant bleeding tendency, tumor metastasis, serious heart disease, or embedded pacemaker
研究组 & 干预措施
electroacupuncture group
In the electroacupuncture group, the acupuncture point prescription is based on the Evidence-based Practice Guidelines for Non-surgical Treatment of lumbar disc Herniation. The best clinical acupuncture treatment strategy was determined by the expert committee.Electroacupuncture was applied to the standard acupoints (BL-23,BL-25,EX-B2,BL-40,GB-34) for 30 min per treatment, and the treatment was performed 3 times per week (with an interval of 1-2 days between treatments), with a total of 12 treatments received over 4 weeks. Point selection and location refer to the current national standard "GB/T 12346-2021 Meridian point Name and Location".
干预措施: electroacupuncture group (Device)
sham-acupuncture group
In the sham-acupuncture group,the prescription of this sham acupuncture scheme was made with reference to SHARE: Report Guidelines and Clinical Trial List of sham acupuncture and Research on acupuncture point Localization in the treatment of chronic low back Pain.Sham-acupuncture treatments were performed on noacupoints (Sham-BL-23,Sham-BL-25,Sham-EX-B2,Sham-BL-40,Sham-GB-34) for a duration of 30 min for each treatment session, and 3 treatments were performed per week (with an interval of 1-2 days between each treatment session), for a total of 12 treatments over 4 weeks.
干预措施: sham-acupuncture group (Device)
结局指标
主要结局
Visual Analogue Scale
时间窗: Measured before treatment, after 2 weeks of treatment, after 4 weeks of treatment, 4 weeks, 12 weeks and 24 weeks after the end of treatment
Visual Analogue Scale is one of the most commonly used single-dimension measurement and evaluation tools for pain intensity. The scale is mainly composed of a 100mm straight line, one end of which means "completely painless" and the other end means "the most severe pain imaginable" or "pain to the extreme." The patient will be asked to place a mark (with a dot) on the line to represent the intensity of the pain they are experiencing at the time.A higher score means a worse result.
次要结局
- Oswestry disability index(Measured before treatment, after 2 weeks of treatment, after 4 weeks of treatment, 4 weeks, 12 weeks and 24 weeks after the end of treatment)
- Japanese Orthopaedic Association scores(Measured before treatment, after 2 weeks of treatment, after 4 weeks of treatment, 4 weeks, 12 weeks and 24 weeks after the end of treatment)
- Hospital Anxiety and Depression Scale(Measured before treatment, after 2 weeks of treatment, after 4 weeks of treatment, 4 weeks, 12 weeks and 24 weeks after the end of treatment)
- the 12-items Short Form Health Survey(Measured before treatment, after 2 weeks of treatment, after 4 weeks of treatment, 4 weeks, 12 weeks and 24 weeks after the end of treatment)
- Number of Participants Experiencing Adverse Reactions During Acupuncture(We will systematically monitor and document any adverse reactions (such as pain, bleeding, infection, etc.) following each session of acupuncture or sham acupuncture within a 4-week, 12-session intervention period. The observational period for this trial)
- Rate of Adverse Reactions During Acupuncture Treatment(Upon the conclusion of the trial, which is anticipated to span approximately 1.5 years, we will compute and report the incidence rate of adverse events based on the tally of occurrences.)