Evaluation of the Pain Relief Effect of Battlefield Acupuncture on Patients With Chronic Low Back Pain Due to Lumbar Spine Degeneration.

September 17, 2025 updated by: Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City

A Randomized Control Trail: Evaluation of the Pain Relief Effect of Battlefield Acupuncture on Patients With Chronic Low Back Pain Due to Lumbar Spine Degeneration.

The Global Burden of Disease's 2023 study shows that lower back pain affects over 619 million people worldwide, with projections reaching 843 million by 2050. It is a common symptom of lumbar spine degeneration, with 84.2% of patients experiencing it. To address this issue, Vietnam's Ministry of Health has released guidelines on "Lumbar Spine Pain" (Yêu thống), combining traditional and modern medicine, including acupuncture, to alleviate pain. However, to achieve better treatment outcomes, the combination of multiple interventions, such as different types of acupuncture, is required. Additionally, the USAF's Integrative Medicine and Acupuncture Center released guidelines in 2021 for Battlefield Acupuncture (BFA), a rapid, safe, and effective pain relief method. Internationally, there are studies on BFA for various types of pain, including lower back pain, but none in Vietnam. Therefore, the investigators conducted this study to evaluate the effects of BFA combined with electroacupuncture and pain medication on chronic lower back pain patients with lumbar spine degeneration in Vietnam.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Global Burden of Disease's 2023 study shows that lower back pain affects over 619 million people worldwide, with projections reaching 843 million by 2050. It is a common symptom of lumbar spine degeneration, with 84.2% of patients experiencing it. To address this issue, Vietnam's Ministry of Health has released guidelines on "Lumbar Spine Pain" (Yêu thống), combining traditional and modern medicine, including acupuncture, to alleviate pain. However, to achieve better treatment outcomes, the combination of multiple interventions, such as different types of acupuncture, is required. Additionally, the USAF Integrative Medicine and Acupuncture Center published a guideline in 2021 for BFA ear acupuncture, specifying points to be acupunctured in the following order: Cingulate gyrus, Subcortex, Omega 2, Shen Men, and Zero. Currently, this method has been extensively researched and has shown its potential in both acute and chronic pain, such as chronic musculoskeletal pain in cancer patients, acute back pain in intensive care units, and non-specific chronic back pain. Despite the proven effectiveness in many studies and the publication of detailed guidelines for BFA in the USA, this potential pain relief method has not been evaluated for effectiveness in Vietnam. Therefore, the investigators conducted this study to evaluate the effects of BFA combined with electroacupuncture and pain medication on chronic lower back pain patients with lumbar spine degeneration in Vietnam.

The investigators conduct a single blind randomized control trail, from March 2025 to October 2025, on 60 low-back-pain patients diagnosed with lumbar spine degeneration (or lumbosacral spondylosis). These patients will be randomly divided into two groups: A (intervention group - 30 patients) and B (sham group - 30 patients). The patients in group A will receive ear acupuncture, while the patients in group B will receive sham ear acupuncture. All patients will be treated with electroacupuncture and prescribed pain medication. Each patient will undergo a 10-day course of treatment (3 sessions per week, each session 1 day apart from the previous one). The details of the intervention will be discussed further below. At the end of each session, the investigators will collect Visual Analog Scale (VAS) scores, and the number of pain medications used. At the end of the 5th and the 10th session, the investigators will collect Brief Pain Inventory (BPI) scores.

Study Type

Interventional

Enrollment (Actual)

60

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 Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Traditional Chinese Medicine faculty - Thống Nhất Hospital
      • Ho Chi Minh City, Vietnam
        • University medical center HCMC branch 3

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:

  • Patients aged 20 years and older.
  • Patients diagnosed with lumbar spine degeneration (Imaging and clinical criteria according to the "Guidelines for Diagnosis and Treatment of Musculoskeletal Diseases" - Ministry of Health of Viet Nam 2014; AAFP-2024).
  • Patients with back pain with a VAS score of ≥ 50mm, continuous or recurrent with the same initial diagnosed cause, lasting from the time of initial diagnosis to the time of study participation for ≥ 3 months.
  • Individuals who have never used auricular acupuncture.
  • Voluntarily agree to participate in the study.

Exclusion Criteria:

  • Individuals with cognitive disorders (Glasgow < 13 points).
  • Individuals are allergic to any component of the ear acupressure seeds, or experiencing anxiety, fear of needles, or with a history of acupuncture syncope.
  • Patients with symptoms of saddle anesthesia, urinary or fecal incontinence, paresthesia or muscle atrophy, progressive muscle weakness.
  • History of cancer or currently undergoing cancer treatment, or unexplained weight loss.
  • Patients who are awakened at night due to back pain.
  • Patients contraindicated the medication used in the study: paracetamol.
  • Pregnant or breastfeeding women.
  • Patients are currently experiencing systemic infection.
  • Individuals with unhealed wounds, ear or lumbar region infections.
  • Currently participating in an intervention study with another drug or device.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experiment
Auricular acupuncture + Electro acupuncture + Pain medication
Device: Ear acupuncture

(According to the guidelines provided in the "BFA - Acupuncture Manual" of the USAF Center for Integrative and Complementary Medicine.)

Procedure:

  • Practitioner: Traditional medicine doctor with a practicing certificate.
  • Tools: Khanh Phong auricular acupuncture needles (license: 287/BYTYDCT)
  • Before needling: Disinfect the skin on both outer ears.
  • Insertion depth: Auricular needles penetrate the skin to a depth of 1.3 mm. Insert the auricular needles alternately on the right and left sides at the following acupoints: Cingulate gyrus, Subcortex, Omega 2, Shen Men, and Zero point. The insertion process stops when one of the following three criteria is met: (1) The patient experiences a 40% reduction in pain on the Visual Analog Scale (VAS), (2) The patient refuses to continue the insertion, or (3) A total of 10 needles have been inserted.
  • After needling: Patient may feel slight pain in the ear area or de qi (a sensation of aching, warmth, and redness at the needling site).
Device: Electro-acupuncture

According to the "Guidelines for the Diagnosis and Treatment of Diseases by Traditional Medicine, combining Traditional Medicine with Modern Medicine" - 2020 - Ministry of Health of Viet Nam.

Procedure:

  • Practitioner: Traditional medicine doctor with a practicing certificate.
  • Tools: Khánh Phong ARLO acupuncture needles, size 0.3 x 25 mm (lincense: TKHQ:102664344900)
  • Disinfect the lumbar region skin.
  • Needle insertion: Insert needles perpendicular to the patient's skin, to a depth of 20 mm. Location: Dai truong du (BL25), Than du (BL23), Jiaji at L4-L5, L5-S1 (Ex-B2), Uy trung (BL40), Yeu duong quan (GV3). After insertion, attach the electrode clips to the needle ends.
  • Electric stimulation: Use a current of 100Hz for 20 minutes - mixed wave.
  • Post-needling: Patient may feel a sensation of de qi (aching, warmth, and redness at the needling site).
Drug: Paracetamol 500 mg

According to the "Guidelines for the Diagnosis and Treatment of Diseases by Traditional Medicine, combining Traditional Medicine with Modern Medicine" - 2020 - Ministry of Health of Viet Nam.

  • Prescriber: Traditional medicine doctor with a practicing certificate.
  • Paracetamol 500mg x 9 tablets: Take 1 tablet per dose, to be used when the pain score on the Visual Analog Scale (VAS) is ≥ 30mm, not exceeding 6 tablets/day. (If the patient still has medication from the previous visit, only prescribe the total amount needed to make up 9 tablets).
Sham Comparator: Sham Comparator
Sham ear acupuncture + Electro acupuncture + Pain medication
Device: Electro-acupuncture

According to the "Guidelines for the Diagnosis and Treatment of Diseases by Traditional Medicine, combining Traditional Medicine with Modern Medicine" - 2020 - Ministry of Health of Viet Nam.

Procedure:

  • Practitioner: Traditional medicine doctor with a practicing certificate.
  • Tools: Khánh Phong ARLO acupuncture needles, size 0.3 x 25 mm (lincense: TKHQ:102664344900)
  • Disinfect the lumbar region skin.
  • Needle insertion: Insert needles perpendicular to the patient's skin, to a depth of 20 mm. Location: Dai truong du (BL25), Than du (BL23), Jiaji at L4-L5, L5-S1 (Ex-B2), Uy trung (BL40), Yeu duong quan (GV3). After insertion, attach the electrode clips to the needle ends.
  • Electric stimulation: Use a current of 100Hz for 20 minutes - mixed wave.
  • Post-needling: Patient may feel a sensation of de qi (aching, warmth, and redness at the needling site).
Drug: Paracetamol 500 mg

According to the "Guidelines for the Diagnosis and Treatment of Diseases by Traditional Medicine, combining Traditional Medicine with Modern Medicine" - 2020 - Ministry of Health of Viet Nam.

  • Prescriber: Traditional medicine doctor with a practicing certificate.
  • Paracetamol 500mg x 9 tablets: Take 1 tablet per dose, to be used when the pain score on the Visual Analog Scale (VAS) is ≥ 30mm, not exceeding 6 tablets/day. (If the patient still has medication from the previous visit, only prescribe the total amount needed to make up 9 tablets).
Device: Sham ear acupuncture

Study uses patches with non-skin-penetrating cotton, at the intervention acupoint areas. Using acupoints matching with the intervention group helps reduce the patients' ability to predict their study group, and the non-penetrating and non-rotating cotton ensure that there is no analgesic effect on the lumbar area caused by auriculotherapy.

Acupoint location: Cingulate gyrus, Subcortex, Omega 2, Shen Men, and Zero points

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: Baseline, during procedure
The Visual analog scale is a continuous scale consisting of a horizontal line (HVAS) or a vertical line (VVAS), typically 10 cm (100 mm) in length. The scale is usually anchored at both ends with the descriptors "no pain" (score 0) and "worst imaginable pain" (score 100 [100 mm scale]). To avoid clustering scores around a preferred number, intermediate points should not be numbered or verbally described. The timing of data collection varies between different studies or examinations, but most respondents are asked to report pain intensity "currently" or pain intensity "in the past 24 hours."
Baseline, during procedure
Brief Pain inventory
Time Frame: Baseline, session 1st, session 5th, session 10th

The BPI is a self-assessment scale for sensory aspects and responses to pain. The scale includes two parts: pain intensity and the degree of impact on various aspects of life. The impact is assessed in different areas of daily living such as sleep, mobility, and emotional well-being. The survey period can be either 7 days or 24 hours. IMMPACT (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials) recommends that BPI be used for clinical trials with patients suffering from chronic pain.

BPI begins with a screening question about the location of the pain that the patient feels needs attention. The main sections include pain intensity scale and the impact of pain. A numerical rating scale from 0 to 10 is used for all items. The endpoints for the pain intensity scale are 0 = 'no pain' and 10 = 'pain as bad as you can imagine', while the endpoints for the quality-of-life scale are 0 = 'no impact' and 10 = 'total impact'.
Baseline, session 1st, session 5th, session 10th
Pain medication used
Time Frame: During procedure
The use of pain medications serves as an indicator of the efficacy of acupuncture as a pain-relief intervention. An increased dependence on analgesic medications among patients signifies a diminished therapeutic effect of acupuncture in alleviating pain symptoms.
During procedure

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 (Actual)

March 15, 2025

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

August 31, 2025

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 13, 2025

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2469/DHYD-HDDD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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