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

NCT07530042 | Not Yet Recruiting DMC

• 1 other identifier: IRB-VN01002/IRB00010293/FWA000
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Low Back Pain (CLBP); Lumbar Spondylosis

Keywords

Electroacupuncture; Auricular Acupressure; Kidney Yin Deficiency

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (2)

• The change of the Oswestry Disability Index (ODI) percentage

  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

  Monitored continuously throughout the 14-day intervention period.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Electroacupuncture + Auricular Acupressure

Device: Electroacupuncture; Device: Auricular Acupressure

Sham Comparator Group

SHAM COMPARATOR

Electroacupuncture + Sham Auricular Acupressure

Device: Electroacupuncture; Device: Sham Auricular Acupressure

Interventions

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.

Experimental Group; Sham Comparator Group

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.

Experimental Group

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.

Sham Comparator Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

Department of Physical Therapy, Le Van Thinh Hospital, 130 Le Van Thinh Street

Ho Chi Minh City, Binh Trung Ward, Vietnam

Location

Related Publications (14)

• 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

  BACKGROUND

• Mu J,Furlan AD,Lam WY,Hsu MY,Ning Z,Lao L

  BACKGROUND

• Moura CC,Chaves ECL,Nogueira DA,Iunes DH,Corrêa HP,Pereira GA,Silvano HM,Azevedo C,Macieira TGR,Chianca TCM

  BACKGROUND

• Yang LH,Duan PB,Hou QM,Du SZ,Sun JF,Mei SJ,Wang XQ

  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.

  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.

  PMID: 22811745 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.

  PMID: 30673051 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.

  PMID: 32186108 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.

  PMID: 35405631 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.

  PMID: 31433010 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.

  PMID: 32333996 BACKGROUND

MeSH Terms

Conditions

Spondylosis

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Central Study Contacts

Nguyen Thi Huong Xuan, MD.

CONTACT

+84388916499; nthxuan.ths.yhct25@ump.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)