Spondylosis Lumbar
Conditions
Keywords
Lumbarsacral Spondylosis, Battlefield acupuncture, Ear acupuncture, Low back pain
Brief 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 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.
Interventions
DEVICEBattlefield 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.
DEVICEElectroacupuncture
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).
DRUGParacetamol 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.
* 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.
Sponsors
Bui Pham Minh Man
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale at session 10 | 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." |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS trajectory across 10 sessions | From baseline to Week 4 (after session 10) | 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. |
| Responder analysis (≥30% and ≥50% VAS reduction) | Week 4 (after session 10) | 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. |
| Time to ≥30% VAS reduction | From baseline to Week 4 (after session 10) | 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. |
| Rescue paracetamol use | From baseline to Week 4 (after session 10) | 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. |
| Brief Pain Inventory (BPI) intensity | Baseline, Week 2 (after session 5), Week 4 (after session 10) | 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"). |
| Brief Pain Inventory (BPI) interference | Baseline, Week 2 (after session 5), Week 4 (after session 10) | 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"). |
| Adverse events | From baseline to Week 4 (after session 10) | 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). |
Countries
Vietnam
Outcome results
None listed