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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Electroacupuncture + Auricular Acupressure |
|
| Sham Comparator Group | Sham Comparator | Electroacupuncture + Sham Auricular Acupressure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The change of the Visual Analog Scale (VAS) Score | 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). | Assessments are conducted before intervention and after each intervention week: Baseline (T0), Day 7 (T1), and Day 14 (T2). |
| Measure | Description | Time Frame |
|---|---|---|
| The change of the Oswestry Disability Index (ODI) percentage | Functional disability assessed using the full 10-item questionnaire (including Pain intensity, Personal care, Lifting, Walking, Sitting, Standing, Sleeping, Sex life, Social life, and Traveling). Each item is scored from 0 to 5, and the total score is converted to a percentage (0-100%). Higher percentages indicate greater functional disability. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nguyen Thi Huong Xuan, MD. | Contact | +84388916499 | nthxuan.ths.yhct25@ump.edu.vn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physical Therapy, Le Van Thinh Hospital, 130 Le Van Thinh Street | Ho Chi Minh City | Binh Trung Ward | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40152243 | Background | 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. | |
| 33306198 | Background |
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Institutional policy and participant privacy.
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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.
|
| Auricular Acupressure | Device | 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. |
|
| Sham Auricular Acupressure | Device | 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. |
|
| 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 | The study will closely monitor and document any unexpected adverse events associated with the procedure. These include bleeding, needle breakage, intolerable pain, vasovagal response (needle fainting), allergic contact dermatitis at the seed application site, or subcutaneous hemorrhage. | Monitored continuously throughout the 14-day intervention period. |
| 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. |
| 35528479 | Background | 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. |
| 28804504 | Background | 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. |
| Background | 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 |
| Background | Oleson T. Auriculotherapy Manual: Chinese and Western Systems of Ear Acupuncture. 4th ed. Elsevier Health Sciences; 2013. 476 p. |
| Background | Wang Y. Microacupuncture in Practice. Churchill Livingstone; 2009. Chapter 7, Ear acupuncture; p. 99-138. |
| Background | 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. |
| 22811745 | Background | Yeh CH, Chien LC, Chiang YC, Huang LC. Auricular point acupressure for chronic low back pain: a feasibility study for 1-week treatment. Evid Based Complement Alternat Med. 2012;2012:383257. doi: 10.1155/2012/383257. Epub 2012 Jul 1. |
| 30673051 | Background | Moura CC, Chaves ECL, Chianca TCM, Ruginsk SG, Nogueira DA, Iunes DH. Effects of auricular acupuncture on chronic pain in people with back musculoskeletal disorders: a randomized clinical trial. Rev Esc Enferm USP. 2019 Jan 21;53:e03418. doi: 10.1590/S1980-220X2018009003418. English, Portuguese. |
| 32186108 | Background | Luo Y, Yang M, Liu T, Zhong X, Tang W, Guo M, Hu Y. Effect of hand-ear acupuncture on chronic low-back pain: a randomized controlled trial. J Tradit Chin Med. 2019 Aug;39(4):587-598. |
| 35405631 | Background | Menezes FDS, Chaves ECL, Mantuani APA, Marino LS, Alcantara MAR, Nassif MS, de Castro Moura C, Carvalho LC, Iunes DH. Effects of low-power laser auriculotherapy on chronic spinal pain: Randomized clinical trial. Complement Ther Clin Pract. 2022 Aug;48:101578. doi: 10.1016/j.ctcp.2022.101578. Epub 2022 Mar 29. |
| 31433010 | Background | Moura CC, Chaves ECL, Cardoso ACLR, Nogueira DA, Azevedo C, Chianca TCM. Auricular acupuncture for chronic back pain in adults: a systematic review and metanalysis. Rev Esc Enferm USP. 2019 Aug 19;53:e03461. doi: 10.1590/S1980-220X2018021703461. English, Portuguese. |
| 32333996 | Background | 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, Provenzano DA, Radcliff KE, Rahmathulla G, Reinsel TE, Rich RL Jr, Robbins DS, Rosolowski KA, Sembrano JN, Sharma AK, Stout AA, Taleghani CK, Tauzell RA, Trammell T, Vorobeychik Y, Yahiro AM. Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of low back pain. Spine J. 2020 Jul;20(7):998-1024. doi: 10.1016/j.spinee.2020.04.006. Epub 2020 Apr 22. |
| ID | Term |
|---|---|
| D055009 | Spondylosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D004599 | Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |
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