Electroacupuncture Treatment for Discogenic Low Back Pain

Официальное название

The Efficacy and Safety of Electroacupuncture Compared With Sham Acupuncture in Patients With Discogenic Low Back Pain: A Multicenter Randomized Controlled Trial

Обзор

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.

Вмешательства

• Устройство electroacupuncture group
  According to the acupuncture prescription, the acupuncture doctor carried out acupuncture and lifting and twisting, and "qi" appeared under the needle. Select waist Jiaji point and Shenshu point on the same side to connect a set of electronic needle therapy instrument, the positive pole (red clip) connected to Shenshu point, the negative pole (white clip) connected to waist Jiaji point, after confirming that the electric current intensity of the electric needle instrument returns to zero, open t
• Устройство sham-acupuncture group
  The investigators fixed the foam pad with one hand and inserted a comfort needle with the other, making sure the needle only touched the surface of the skin and did not penetrate the point. After the completion of all acupoint operations, the operator selected the simulated needle insertion points of Jiaji point on the waist and Shenshu point on the same side. An electroacupuncture treatment device designed to connect a circuit interrupt treatment is operated with the electroacupuncture group, a

Первичные конечные точки

• Visual Analogue Scale [Срок оценки: 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]

Вторичные конечные точки (6)

• Oswestry disability index [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Hospital — Пекин

Публикации

• Lee B, Kwon CY, Lee HW, Nielsen A, Wieland LS, Kim TH, Birch S, Alraek T, Lee MS. Needling Point Location Used in Sham Acupuncture for Chronic Nonspecific Low Back Pain: A Systematic Review and Network Meta-Analysis. JAMA Netw Open. 2023 Sep 5;6(9):e2332452. doi: 10.1001/jamanetworkopen.2023.32452. PMID 37672270
• Ma P, Liu X, Liu Z, Guo Y, Zhou K, Bian Z, Sun C, Liu T, Xiong Z, Xie Y, Lu Y, Lao L, He L, Liu B, Liu C, Yan S; SHARE Workgroup. The SHARE: SHam Acupuncture REporting guidelines and a checklist in clinical trials. J Evid Based Med. 2023 Dec;16(4):428-431. doi: 10.1111/jebm.12560. Epub 2023 Oct 31. No abstract available. PMID 37906211
• Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, St PMID 18055266
• Tu JF, Shi GX, Yan SY, Ni GX, Yu FT, Cai GW, Liu ZS, Ma CY, Wang LQ, Yang JW, Zhou XQ, Meng XL, Fu HY, Li J, Wan WJ, Sun TH, Wang XZ, Liu CZ. Acupuncture vs Sham Acupuncture for Chronic Sciatica From Herniated Disk: A Randomized Clinical Trial. JAMA Intern Med. 2024 Dec 1;184(12):1417-1424. doi: 10.1001/jamainternmed.2024.5463. PMID 39401008
• Kreiner DS, Matz P, Bono CM, Cho CH, Easa JE, Ghiselli G, Ghogawala Z, Reitman CA, Resnick DK, Watters WC 3rd, Annaswamy TM, Baisden J, Bartynski WS, Bess S, Brewer RP, Cassidy RC, Cheng DS, Christie SD, Chutkan NB, Cohen BA, Dagenais S, Enix DE, Dougherty P, Golish SR, Gulur P, Hwang SW, Kilincer C, King JA, Lipson AC, Lisi AJ, Meagher RJ, O'Toole JE, Park P, Pekmezci M, Perry DR, Prasad R, Prove PMID 32333996
• Kim G, Kim D, Moon H, Yoon DE, Lee S, Ko SJ, Kim B, Chae Y, Lee IS. Acupuncture and Acupoints for Low Back Pain: Systematic Review and Meta-Analysis. Am J Chin Med. 2023;51(2):223-247. doi: 10.1142/S0192415X23500131. Epub 2022 Dec 31. PMID 36585839
• He Y, Guo X, May BH, Zhang AL, Liu Y, Lu C, Mao JJ, Xue CC, Zhang H. Clinical Evidence for Association of Acupuncture and Acupressure With Improved Cancer Pain: A Systematic Review and Meta-Analysis. JAMA Oncol. 2020 Feb 1;6(2):271-278. doi: 10.1001/jamaoncol.2019.5233. PMID 31855257
• Castellini G, Pillastrini P, Vanti C, Bargeri S, Giagio S, Bordignon E, Fasciani F, Marzioni F, Innocenti T, Chiarotto A, Gianola S, Bertozzi L. Some conservative interventions are more effective than others for people with chronic non-specific neck pain: a systematic review and network meta-analysis. J Physiother. 2022 Oct;68(4):244-254. doi: 10.1016/j.jphys.2022.09.007. Epub 2022 Oct 17. PMID 36266185

Идентификаторы

NCT: NCT06703671 · 2024BJYYEC-KY198-04 · BJ-2024-205

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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