Clinical Research Directory
Browse clinical research sites, groups, and studies.
Battlefield Acupuncture as an Adjunct to Electroacupuncture for Chronic Low Back Pain Due to Lumbar Spine Osteoarthritis
Sponsor: Bui Pham Minh Man
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.
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.
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-03-15
Completion Date
2025-08-31
Last Updated
2026-10-20
Healthy Volunteers
No
Conditions
Interventions
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.
Electroacupuncture
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)
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 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.
Locations (2)
Traditional Chinese Medicine faculty - Thống Nhất Hospital
Ho Chi Minh City, Vietnam
University medical center HCMC branch 3
Ho Chi Minh City, Vietnam