Spondylosis LumbarNCT06874959
Battlefield Acupuncture as an Adjunct to Electroacupuncture for Chronic Low Back Pain Due to Lumbar Spine Osteoarthritis
A study testing Battlefield Acupuncture (BFA), Electroacupuncture and Paracetamol 500 mg (as-needed) in people with Spondylosis Lumbar, run by Bui Pham Minh Man at 2 sites in Vietnam.
Trial summary
Chronic low back pain due to lumbar spine osteoarthritis is a common and disabling condition. Many patients do not get enough relief from standard treatments. Battlefield Acupuncture (BFA) is a type of ear acupuncture used by the US military for rapid pain relief, but it has not been studied as an add-on to… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Spondylosis Lumbar
- What is being tested?
- Battlefield Acupuncture (BFA), Electroacupuncture and Paracetamol 500 mg (as-needed)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesVietnam
- Study dates
- 15 Mar 2025to 31 Aug 2025
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 years and older.
- Patients diagnosed with lumbar spine osteoarthritis (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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
Traditional Chinese Medicine faculty - Thống Nhất Hospital
Ho Chi Minh City
University medical center HCMC branch 3
Ho Chi Minh City
About this study
Official title: Battlefield Acupuncture as an Adjunct to Electroacupuncture for Chronic Low Back Pain Due to Lumbar Spine Osteoarthritis: a Two-centre, Randomised, Sham-controlled Trial.
Chronic low back pain due to lumbar spine osteoarthritis is a common and disabling condition. Many patients do not get enough relief from standard treatments. Battlefield Acupuncture (BFA) is a type of ear acupuncture used by the US military for rapid pain relief, but it has not been studied as an add-on to electroacupuncture (a standard acupuncture technique) in Vietnam.
From March 2025 to July 2025, at the Faculty of Acupuncture and Life Cultivation, University Medical Center Ho Chi Minh City Branch 3, and the Faculty of Traditional Medicine, Thong Nhat Hospital, sixty adults with chronic low back pain due to lumbar spine osteoarthritis were randomly assigned to one of two groups. Both groups received 10 sessions of electroacupuncture over 3 weeks, plus paracetamol as needed. One group also received BFA; the other group received a sham (inactive) ear acupuncture. Neither the participants nor the outcome assessors knew which group each participant was in. Pain intensity, pain interference with daily activities, and side effects were measured.
Adults aged 20 years or older with chronic low back pain due to lumbar spine osteoarthritis, who had not previously used ear acupuncture, and who agreed to participate.
Read the detailed description
Chronic low back pain (LBP) due to lumbar spine osteoarthritis is a leading cause of disability, affecting over 619 million people worldwide in 2020 and projected to reach 843 million by 2050. In lumbar spine osteoarthritis, LBP is the predominant symptom, reported in up to 84.2% of cases. Despite available treatments, many patients remain inadequately relieved, highlighting the need for safe, rapidly acting adjunctive therapies.
Battlefield Acupuncture (BFA) is a standardized auricular acupuncture protocol using five acupoints: cingulate gyrus, thalamus, Omega 2, point zero, and shen men in both ears. It is widely used in the US military for rapid pain relief. However, evidence for BFA remains mixed. A 2021 meta-analysis found no significant improvement in pain intensity versus various controls (pooled MD = -0.17, 95% CI [-0.61, 0.28], p = 0.62; 5 RCTs, n = 344), while a 2025 systematic review reported mixed results and recommended BFA as an adjunct to other modalities, including electroacupuncture. A 2026 systematic review of 7 RCTs (n = 758) in emergency department settings reported that 71% of studies showed positive results, but concluded that methodological quality remained low and further high-quality trials are needed. Based on our search of PubMed, Embase, and the Cochrane Library up to September 2025, no randomised trial has directly evaluated BFA as an adjunct to electroacupuncture, particularly in chronic LBP due to lumbar spine osteoarthritis.
Furthermore, in Vietnam, two BFA acupoints (Omega 2 and cingulate gyrus) are absent from official Ministry of Health documents, and no Vietnamese study has evaluated this protocol. We therefore conducted this two-centre, randomised, controlled trial to assess whether adding BFA to a standardised background regimen of electroacupuncture plus as-needed paracetamol improved pain and reduced pain interference with daily function compared with electroacupuncture plus sham auricular acupuncture in Vietnamese patients with chronic LBP due to lumbar spine osteoarthritis.
This was a two-centre, randomised, parallel-group, sham-controlled trial with 1:1 allocation, conducted at the Faculty of Acupuncture and Life Cultivation, University Medical Center Ho Chi Minh City Branch 3, and the Faculty of Traditional Medicine, Thong Nhat Hospital, from March 2025 to July 2025. Sixty participants with chronic LBP due to lumbar spine osteoarthritis were randomised to receive either BFA plus electroacupuncture (AA group) or sham auricular acupuncture plus electroacupuncture (control group). Both groups received 10 electroacupuncture sessions delivered three times weekly, one day apart, and as-needed paracetamol. Active or sham auricular intervention was applied at sessions 1, 3, 5, 7, and 9. The primary outcome was VAS at session 10; secondary outcomes included VAS trajectory, BPI intensity and interference, responder rates, time to ≥30% VAS reduction, and adverse events.
- Conditions
- Spondylosis Lumbar
- Being tested
- Battlefield Acupuncture (BFA), Electroacupuncture, Paracetamol 500 mg (as-needed), Sham auricular acupuncture
- Keywords
- Lumbarsacral Spondylosis, Battlefield acupuncture, Ear acupuncture, Low back pain
- Medical subject headings
- Spondylosis, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Battlefield Acupuncture (BFA)Device
(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: Five acupoints were needled bilaterally in the order: cingulate gyrus, thalamus, Omega 2, point zero, and shen men, alternating between ears to a depth of 1.3 mm. Between insertions, patients walked 10-20 steps and re-rated their pain.
- Stopping criteria: Insertion stopped if (1) VAS decreased to 0-10 mm on the 100-mm VAS, (2) a significant adverse event occurred, (3) the patient refused to continue, or (4) 10 needles had been placed.
- After needling: Patients might feel stinging, burning, and/or redness due to local auricular reactions. Needles were retained for 3-5 days with adhesive patches.
ElectroacupunctureDevice
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: Khanh Phong ARLO acupuncture needles, size 0.3 × 25 mm (license: 220000031/PCBB-BYT).
- Disinfect the lumbar region skin.
- Needle insertion: Insert needles perpendicular to the patient's skin, to a depth of 20 mm. Location: BL23, BL25, Jiaji at L4-L5 and L5-S1, BL40 bilaterally, and GV3. After insertion, attach the electrode clips to the needle ends.
- Electric stimulation: Use a dense-disperse waveform alternating between 2 Hz and 100 Hz, at an intensity titrated to the maximum comfortable level, for 20 minutes.
- Post-needling: Patient may feel a sensation of de qi (aching, soreness, numbness, heaviness, and/or distension).
Paracetamol 500 mg (as-needed)Drug
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.
- Dosage: Paracetamol 500 mg, 1 tablet per dose, with a minimum interval of 4 hours between doses, and only when both conditions were met: (1) VAS ≥ 30 mm and (2) the patient could not tolerate the pain.
- Maximum: Not exceeding 6 tablets/day. Patients were advised not to use other analgesic, anti-inflammatory, or herbal preparations.
Sham auricular acupunctureDevice
- With the same BFA protocol as the AA group, including walking and pain re-rating between applications, the control group received blank adhesive patches with soft non-penetrating, non-rotating cotton applied without manipulation to minimise acupressure effects.
- Acupoint location: Cingulate gyrus, thalamus, Omega 2, Shen Men, and Point Zero (matching the intervention group).
- Retention: Patches were retained for 3-5 days and removed at session 10 or when detached.
| Study group | Role | What they receive |
|---|---|---|
| AA group | Experimental | Battlefield Acupuncture (BFA) + Electroacupuncture + as-needed paracetamol Receives: Device: Battlefield Acupuncture (BFA); Device: Electroacupuncture; Drug: Paracetamol 500 mg (as-needed) |
| Control group | Sham comparator | Sham auricular acupuncture + Electroacupuncture + as-needed paracetamol Receives: Device: Electroacupuncture; Drug: Paracetamol 500 mg (as-needed); Device: Sham auricular acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale at session 10
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."
Measured: Baseline and Week 4 (after session 10)
Secondary outcomes (7)
VAS trajectory across 10 sessions
VAS scores were assessed at baseline and immediately after each of the 10 treatment sessions to evaluate the longitudinal trajectory of pain intensity. The full VAS profile was analysed using a mixed model for repeated measures (MMRM) with session as a categorical variable.
Measured: From baseline to Week 4 (after session 10)
Responder analysis (≥30% and ≥50% VAS reduction)
Proportions of participants achieving ≥30% and ≥50% reduction in VAS from baseline to session 10 were compared between groups using Fisher's exact test. Risk difference and number needed to treat (NNT) were calculated.
Measured: Week 4 (after session 10)
Time to ≥30% VAS reduction
Time to achieving ≥30% reduction in VAS from baseline was analysed using Kaplan-Meier survival analysis, with between-group comparison by log-rank test and hazard ratio (HR) estimation.
Measured: From baseline to Week 4 (after session 10)
Rescue paracetamol use
Paracetamol 500 mg was used as rescue analgesia, prescribed only when both conditions were met: (1) VAS ≥30 mm and (2) the patient could not tolerate the pain. The number of tablets used was recorded after each session.
Measured: From baseline to Week 4 (after session 10)
Brief Pain Inventory (BPI) intensity
The BPI is a self-reported measure of pain intensity, recommended by IMMPACT for chronic pain and well correlated with established back pain scales such as the RMDQ. Pain intensity was rated on a 0-10 numerical rating scale (0 = "no pain"; 10 = "pain as bad as you can imagine").
Measured: Baseline, Week 2 (after session 5), Week 4 (after session 10)
Brief Pain Inventory (BPI) interference
The BPI interference subscale assesses the impact of pain on daily functioning, including sleep, mobility, and emotional well-being. Items were rated on a 0-10 numerical rating scale (0 = "no impact"; 10 = "total impact").
Measured: Baseline, Week 2 (after session 5), Week 4 (after session 10)
Adverse events
All adverse events during the treatment period were recorded on a case report form capturing onset, duration, severity, attribution (BFA, sham patch, or EA), management, and outcome. Events were classified as local (bleeding, bruising, needle-site pain, local infection), systemic (dizziness, nausea, syncope), or device-related (needle dislodgement).
Measured: From baseline to Week 4 (after session 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start15 Mar 2025
- Primary completion31 Jul 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Spondylosis LumbarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bui Pham Minh Man
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874959
- Sponsor's protocol ID
- 2469/DHYD-HDDD
- Status last verified
- Oct 2026
- First submitted
- 26 Feb 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maharty DC, Hines SC, Brown RB. Chronic Low Back Pain in Adults: Evaluation and Management. Am Fam Physician. 2024 Mar;109(3):233-244.
PubMed 38574213Song CY, Chen CH, Chen TW, Chiang HY, Hsieh CL. Assessment of Low Back Pain: Reliability and Minimal Detectable Change of the Brief Pain Inventory. Am J Occup Ther. 2022 May 1;76(3):7603205040. doi: 10.5014/ajot.2022.044420.
PubMed 35301518Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
PubMed 22588748Murakami M, Fox L, Dijkers MP. Ear Acupuncture for Immediate Pain Relief-A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Pain Med. 2017 Mar 1;18(3):551-564. doi: 10.1093/pm/pnw215.
PubMed 28395101Fox LM, Murakami M, Danesh H, Manini AF. Battlefield acupuncture to treat low back pain in the emergency department. Am J Emerg Med. 2018 Jun;36(6):1045-1048. doi: 10.1016/j.ajem.2018.02.038. Epub 2018 Feb 27.
PubMed 29550099Mao JJ, Liou KT, Baser RE, Bao T, Panageas KS, Romero SAD, Li QS, Gallagher RM, Kantoff PW. Effectiveness of Electroacupuncture or Auricular Acupuncture vs Usual Care for Chronic Musculoskeletal Pain Among Cancer Survivors: The PEACE Randomized Clinical Trial. JAMA Oncol. 2021 May 1;7(5):720-727. doi: 10.1001/jamaoncol.2021.0310.
PubMed 33734288Hướng dẫn Chẩn đoán và Điều trị bệnh theo Y học cổ truyền, kết hợp Y học cổ truyền với Y học hiện đại (2020).
GBD 2021 Low Back Pain Collaborators. Global, regional, and national burden of low back pain, 1990-2020, its attributable risk factors, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 May 22;5(6):e316-e329. doi: 10.1016/S2665-9913(23)00098-X. eCollection 2023 Jun.
PubMed 37273833
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Battlefield Acupuncture as an Adjunct to Electroacupuncture for Chronic Low Back Pain Due to Lumbar Spine Osteoarthritis: a Two-centre, Randomised, Sham-controlled Trial.
- ClinicalTrials.gov ID
- NCT06874959
- Acronym / sponsor ID
- 2469/DHYD-HDDD
- Conditions
- Spondylosis Lumbar
- Keywords
- Lumbarsacral Spondylosis, Battlefield acupuncture, Ear acupuncture, Low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bui Pham Minh ManUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic low back pain due to lumbar spine osteoarthritis is a common and disabling condition. Many patients do not get enough relief from standard treatments. Battlefield Acupuncture (BFA) is a type of ear acupuncture used by the US military for rapid pain relief, but it has not been studied as an add-on to electroacupuncture (a standard acupuncture technique) in Vietnam.
From March 2025 to July 2025, at the Faculty of Acupuncture and Life Cultivation, University Medical Center Ho Chi Minh City Branch 3, and the Faculty of Traditional Medicine, Thong Nhat Hospital, sixty adults with chronic low back pain due to lumbar spine osteoarthritis were randomly assigned to one of two groups. Both groups received 10 sessions of electroacupuncture over 3 weeks, plus paracetamol as needed. One group also received BFA; the other group received a sham (inactive) ear acupuncture. Neither the participants nor the outcome assessors knew which group each participant was in. Pain intensity, pain interference with daily activities, and side effects were measured.
Adults aged 20 years or older with chronic low back pain due to lumbar spine osteoarthritis, who had not previously used ear acupuncture, and who agreed to participate.
Detailed description
Chronic low back pain (LBP) due to lumbar spine osteoarthritis is a leading cause of disability, affecting over 619 million people worldwide in 2020 and projected to reach 843 million by 2050. In lumbar spine osteoarthritis, LBP is the predominant symptom, reported in up to 84.2% of cases. Despite available treatments, many patients remain inadequately relieved, highlighting the need for safe, rapidly acting adjunctive therapies.
Battlefield Acupuncture (BFA) is a standardized auricular acupuncture protocol using five acupoints: cingulate gyrus, thalamus, Omega 2, point zero, and shen men in both ears. It is widely used in the US military for rapid pain relief. However, evidence for BFA remains mixed. A 2021 meta-analysis found no significant improvement in pain intensity versus various controls (pooled MD = -0.17, 95% CI [-0.61, 0.28], p = 0.62; 5 RCTs, n = 344), while a 2025 systematic review reported mixed results and recommended BFA as an adjunct to other modalities, including electroacupuncture. A 2026 systematic review of 7 RCTs (n = 758) in emergency department settings reported that 71% of studies showed positive results, but concluded that methodological quality remained low and further high-quality trials are needed. Based on our search of PubMed, Embase, and the Cochrane Library up to September 2025, no randomised trial has directly evaluated BFA as an adjunct to electroacupuncture, particularly in chronic LBP due to lumbar spine osteoarthritis.
Furthermore, in Vietnam, two BFA acupoints (Omega 2 and cingulate gyrus) are absent from official Ministry of Health documents, and no Vietnamese study has evaluated this protocol. We therefore conducted this two-centre, randomised, controlled trial to assess whether adding BFA to a standardised background regimen of electroacupuncture plus as-needed paracetamol improved pain and reduced pain interference with daily function compared with electroacupuncture plus sham auricular acupuncture in Vietnamese patients with chronic LBP due to lumbar spine osteoarthritis.
This was a two-centre, randomised, parallel-group, sham-controlled trial with 1:1 allocation, conducted at the Faculty of Acupuncture and Life Cultivation, University Medical Center Ho Chi Minh City Branch 3, and the Faculty of Traditional Medicine, Thong Nhat Hospital, from March 2025 to July 2025. Sixty participants with chronic LBP due to lumbar spine osteoarthritis were randomised to receive either BFA plus electroacupuncture (AA group) or sham auricular acupuncture plus electroacupuncture (control group). Both groups received 10 electroacupuncture sessions delivered three times weekly, one day apart, and as-needed paracetamol. Active or sham auricular intervention was applied at sessions 1, 3, 5, 7, and 9. The primary outcome was VAS at session 10; secondary outcomes included VAS trajectory, BPI intensity and interference, responder rates, time to ≥30% VAS reduction, and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AA group | Experimental | Device: Battlefield Acupuncture (BFA), Device: Electroacupuncture, Drug: Paracetamol 500 mg (as-needed)Battlefield Acupuncture (BFA) + Electroacupuncture + as-needed paracetamol |
| Control group | Sham comparator | Device: Electroacupuncture, Drug: Paracetamol 500 mg (as-needed), Device: Sham auricular acupunctureSham auricular acupuncture + Electroacupuncture + as-needed paracetamol |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 20 years and older.
- Patients diagnosed with lumbar spine osteoarthritis (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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Battlefield Acupuncture (BFA)(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: Five acupoints were needled bilaterally in the order: cingulate gyrus, thalamus, Omega 2, point zero, and shen men, alternating between ears to a depth of 1.3 mm. Between insertions, patients walked 10-20 steps and re-rated their pain. * Stopping criteria: Insertion stopped if (1) VAS decreased to 0-10 mm on the 100-mm VAS, (2) a significant adverse event occurred, (3) the patient refused to continue, or (4) 10 needles had been placed. * After needling: Patients might feel stinging, burning, and/or redness due to local auricular reactions. Needles were retained for 3-5 days with adhesive patches. | Device | AA group |
| ElectroacupunctureAccording 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: Khanh Phong ARLO acupuncture needles, size 0.3 × 25 mm (license: 220000031/PCBB-BYT). * Disinfect the lumbar region skin. * Needle insertion: Insert needles perpendicular to the patient's skin, to a depth of 20 mm. Location: BL23, BL25, Jiaji at L4-L5 and L5-S1, BL40 bilaterally, and GV3. After insertion, attach the electrode clips to the needle ends. * Electric stimulation: Use a dense-disperse waveform alternating between 2 Hz and 100 Hz, at an intensity titrated to the maximum comfortable level, for 20 minutes. * Post-needling: Patient may feel a sensation of de qi (aching, soreness, numbness, heaviness, and/or distension). | Device | AA group, Control group |
| Paracetamol 500 mg (as-needed)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. * Dosage: Paracetamol 500 mg, 1 tablet per dose, with a minimum interval of 4 hours between doses, and only when both conditions were met: (1) VAS ≥ 30 mm and (2) the patient could not tolerate the pain. * Maximum: Not exceeding 6 tablets/day. Patients were advised not to use other analgesic, anti-inflammatory, or herbal preparations. | Drug | AA group, Control group |
| Sham auricular acupuncture* With the same BFA protocol as the AA group, including walking and pain re-rating between applications, the control group received blank adhesive patches with soft non-penetrating, non-rotating cotton applied without manipulation to minimise acupressure effects. * Acupoint location: Cingulate gyrus, thalamus, Omega 2, Shen Men, and Point Zero (matching the intervention group). * Retention: Patches were retained for 3-5 days and removed at session 10 or when detached. | Device | Control group |
Primary outcome
Visual Analog Scale at session 10
Time frame: Baseline and Week 4 (after session 10)
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."
7 secondary outcomes
VAS trajectory across 10 sessions
Time frame: From baseline to Week 4 (after session 10)
Responder analysis (≥30% and ≥50% VAS reduction)
Time frame: Week 4 (after session 10)
Time to ≥30% VAS reduction
Time frame: From baseline to Week 4 (after session 10)
Rescue paracetamol use
Time frame: From baseline to Week 4 (after session 10)
Brief Pain Inventory (BPI) intensity
Time frame: Baseline, Week 2 (after session 5), Week 4 (after session 10)
Brief Pain Inventory (BPI) interference
Time frame: Baseline, Week 2 (after session 5), Week 4 (after session 10)
Adverse events
Time frame: From baseline to Week 4 (after session 10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 38574213Maharty DC, Hines SC, Brown RB. Chronic Low Back Pain in Adults: Evaluation and Management. Am Fam Physician. 2024 Mar;109(3):233-244.
- Background: PubMed 35301518Song CY, Chen CH, Chen TW, Chiang HY, Hsieh CL. Assessment of Low Back Pain: Reliability and Minimal Detectable Change of the Brief Pain Inventory. Am J Occup Ther. 2022 May 1;76(3):7603205040. doi: 10.5014/ajot.2022.044420.
- Background: PubMed 22588748Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
- Background: PubMed 28395101Murakami M, Fox L, Dijkers MP. Ear Acupuncture for Immediate Pain Relief-A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Pain Med. 2017 Mar 1;18(3):551-564. doi: 10.1093/pm/pnw215.
- Background: PubMed 29550099Fox LM, Murakami M, Danesh H, Manini AF. Battlefield acupuncture to treat low back pain in the emergency department. Am J Emerg Med. 2018 Jun;36(6):1045-1048. doi: 10.1016/j.ajem.2018.02.038. Epub 2018 Feb 27.
- Background: PubMed 33734288Mao JJ, Liou KT, Baser RE, Bao T, Panageas KS, Romero SAD, Li QS, Gallagher RM, Kantoff PW. Effectiveness of Electroacupuncture or Auricular Acupuncture vs Usual Care for Chronic Musculoskeletal Pain Among Cancer Survivors: The PEACE Randomized Clinical Trial. JAMA Oncol. 2021 May 1;7(5):720-727. doi: 10.1001/jamaoncol.2021.0310.
- BackgroundHướng dẫn Chẩn đoán và Điều trị bệnh theo Y học cổ truyền, kết hợp Y học cổ truyền với Y học hiện đại (2020).
- Background: PubMed 37273833GBD 2021 Low Back Pain Collaborators. Global, regional, and national burden of low back pain, 1990-2020, its attributable risk factors, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 May 22;5(6):e316-e329. doi: 10.1016/S2665-9913(23)00098-X. eCollection 2023 Jun.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Battlefield Acupuncture (BFA), Electroacupuncture and Paracetamol 500 mg (as-needed) in people with Spondylosis Lumbar, run by Bui Pham Minh Man at 2 sites 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 5 inclusion and 10 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 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Visual Analog Scale at session 10 (time frame: Baseline and Week 4 (after session 10)). 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 NCT06874959, which also lists 8 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 20 Oct 2026.