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

April 8, 2026 updated by: Nguyen Le Viet Hung, University of Medicine and Pharmacy at Ho Chi Minh City

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Vietnam
    • Binh Trung Ward
      • Ho Chi Minh City, Binh Trung Ward, Vietnam
        • Department of Physical Therapy, Le Van Thinh Hospital, 130 Le Van Thinh Street
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Electroacupuncture + Auricular Acupressure
Device: 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.
Device: 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.
Sham Comparator: Sham Comparator Group
Electroacupuncture + Sham Auricular Acupressure
Device: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of the Oswestry Disability Index (ODI) percentage
Time Frame: Assessments are conducted before intervention and after each intervention week: Baseline (T0), Day 7 (T1), and Day 14 (T2).
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.
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
Time Frame: Monitored continuously throughout the 14-day intervention period.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 8, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-VN01002/IRB00010293/FWA000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Institutional policy and participant privacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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