Efficacy of Electroacupuncture Combined With Auricular Acupressure for Chronic Low Back Pain.

Официальное название

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.

Обзор

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.

Подробное описание

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).

Вмешательства

• Устройство Electroacupuncture
  Using sterile, single-use 0.30x25mm needles, the investigator will perform acupuncture at Jiaji L2-S1 (Ex-B2), Shenshu (BL23), Weizhong (BL40), Sanyinjiao (SP6), and Fuliu (KI7). A reinforcing method will be applied with perpendicular insertion at a depth of 0.4 - 0.8 cm. After achieving the 'Deqi' sensation, needles will be connected to a KWD-808-I device to deliver a biphasic spike pulse (continuous wave) at a frequency of 100Hz for 20 minutes, with intensity adjusted to patient tolerance.
• Устройство Auricular Acupressure
  Using Vaccaria segetalis seeds at Shenmen (TF4), Subcortex (AT4), Lumbar spine (AH9), Kidney (CO10). The seeds are applied using skin-colored adhesive patches. The acupuncturist will manually press each ear point for 5 minutes during the electroacupuncture session (total 20 mins). Frequency: 1 session/day, 5 sessions/week, for 2 weeks.
• Устройство Sham Auricular Acupressure
  Using the exact same Vaccaria segetalis seeds and identical adhesive patches to ensure participants cannot visually or physically tell the difference from the real treatment. Seeds are placed at non-specific points: Anus (HX5), Shoulder (SF4), Lung (CO14), Tooth (LO1). The acupuncturist will manually press each point for 5 minutes (total 20 mins). Frequency: 1 session/day, 5 sessions/week, for 2 weeks.

Первичные конечные точки

• The change of the Visual Analog Scale (VAS) Score [Срок оценки: Assessments are conducted before intervention and after each intervention week: Baseline (T0), Day 7 (T1), and Day 14 (T2).]

Вторичные конечные точки (2)

• The change of the Oswestry Disability Index (ODI) percentage [Срок оценки: 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 [Срок оценки: Monitored continuously throughout the 14-day intervention period.]

Критерии участия

Критерии включения

• Age between 40 and 70 years.
• Low back pain persisting for ≥ 12 weeks.
• Pain intensity: 30 ≤ VAS ≤ 70.
• 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.

Критерии исключения

• 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).

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Вьетнам · 1 центр

• Department of Physical Therapy, Le Van Thinh Hospital, 130 Le Van Thinh Street — Ho Chi Minh City

Публикации

• Kawi J, Yeh CH, Lukkahatai N, Wu H, Morone NE, Glick R, Schlenk EA, Campbell C, Thrul J, Huang X, Wang H, Jia HM, Christo P, Johnson C. Auricular point acupressure for older adults with chronic low back pain: a randomized controlled trial. Pain Med. 2025 Sep 1;26(9):515-526. doi: 10.1093/pm/pnaf035. PMID 40152243
• Mu J, Furlan AD, Lam WY, Hsu MY, Ning Z, Lao L. Acupuncture for chronic nonspecific low back pain. Cochrane Database Syst Rev. 2020 Dec 11;12(12):CD013814. doi: 10.1002/14651858.CD013814. PMID 33306198
• Moura CC, Chaves ECL, Nogueira DA, Iunes DH, Correa HP, Pereira GA, Silvano HM, Azevedo C, Macieira TGR, Chianca TCM. Effects of ear acupuncture combined with cupping therapy on severity and threshold of chronic back pain and physical disability: A randomized clinical trial. J Tradit Complement Med. 2021 Jul 27;12(2):152-161. doi: 10.1016/j.jtcme.2021.07.008. eCollection 2022 Mar. PMID 35528479
• Yang LH, Duan PB, Hou QM, Du SZ, Sun JF, Mei SJ, Wang XQ. Efficacy of Auricular Acupressure for Chronic Low Back Pain: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Evid Based Complement Alternat Med. 2017;2017:6383649. doi: 10.1155/2017/6383649. Epub 2017 Jul 18. PMID 28804504
• Peng K, Feng L, Dai M, Liu W, Pu L, Si Y. Clinical effect observation of the treatment of non-specific low back pain of kidney yin deficiency type by tonifying lung yin and nourishing kidney yin at five acupoints of lung meridian. Yiyao Qianyan. 2025;15(30):83-86
• Oleson T. Auriculotherapy Manual: Chinese and Western Systems of Ear Acupuncture. 4th ed. Elsevier Health Sciences; 2013. 476 p.
• Wang Y. Microacupuncture in Practice. Churchill Livingstone; 2009. Chapter 7, Ear acupuncture; p. 99-138.
• Nguyen DHT, Nguyen ST, Le MQH, Nguyen NNT, Nguyen TH, Le BN, et al. Efficacy of auricular acupuncture combined with electroacupuncture for chronic low back pain: A randomised controlled trial. Vietnam J Sci Technol Eng. 2024. doi: 10.31276/VJSTE.2024.0106.

Идентификаторы

NCT: NCT07530042 · IRB-VN01002/IRB00010293/FWA000

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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