AzTrials
AzTrials

Chronic Low Back Pain (CLBP)NCT07530042

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

A study testing Electroacupuncture and Auricular Acupressure in people with Chronic Low Back Pain (CLBP) and Lumbar Spondylosis, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 40 to 70 years
What is being tested?
Electroacupuncture and Auricular Acupressure
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
1 siteVietnam
Study dates
20 Apr 2026to 30 Oct 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

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

    Ho Chi Minh City, Binh Trung Ward

Other trials in Vietnam

About this study

Official title: 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.

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.

Read the detailed description

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).
Being tested
Electroacupuncture, Auricular Acupressure, Sham Auricular Acupressure
Keywords
Electroacupuncture, Auricular Acupressure, Kidney Yin Deficiency
Medical subject headings
Spondylosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElectroacupunctureDevice

    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.

  • Auricular AcupressureDevice

    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 AcupressureDevice

    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.

Study groups in NCT07530042
Study groupRoleWhat they receive
Experimental GroupExperimentalElectroacupuncture + Auricular Acupressure
Receives: Device: Electroacupuncture; Device: Auricular Acupressure
Sham Comparator GroupSham comparatorElectroacupuncture + Sham Auricular Acupressure
Receives: Device: Electroacupuncture; Device: Sham Auricular Acupressure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Assessments are conducted before intervention and after each intervention week: Baseline (T0), Day 7 (T1), and Day 14 (T2).

Secondary outcomes (2)

  1. 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.

    Measured: Assessments are conducted before intervention and after each intervention week: Baseline (T0), Day 7 (T1), and Day 14 (T2).

  2. 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.

    Measured: Monitored continuously throughout the 14-day intervention period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2026
  2. Study start20 Apr 2026
  3. Primary completion30 Oct 2026
  4. Study completion30 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07530042
Sponsor's protocol ID
IRB-VN01002/IRB00010293/FWA000
Status last verified
Oct 2026
First submitted
8 Apr 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Institutional policy and participant privacy.

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

  • 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.

    PubMed 22811745

  • 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.

    PubMed 30673051

  • 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.

    PubMed 32186108

  • 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.

    PubMed 35405631

  • 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.

    PubMed 31433010

  • 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.

    PubMed 32333996

Questions about this trial

What is this clinical trial studying?

A study testing Electroacupuncture and Auricular Acupressure in people with Chronic Low Back Pain (CLBP) and Lumbar Spondylosis, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change of the Visual Analog Scale (VAS) Score (time frame: Assessments are conducted before intervention and after each intervention week: Baseline (T0), Day 7 (T1), and Day 14 (T2).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07530042, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in