Evaluation of the Pain Relief Effect of Battlefield Acupuncture on Patients With Chronic Low Back Pain Due to Lumbar Spine Degeneration.
NCT ID: NCT06874959
Last Updated: 2025-09-19
Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2025-03-15
2025-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experiment
Auricular acupuncture + Electro acupuncture + Pain medication
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).
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).
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 ear acupuncture + Electro acupuncture + Pain medication
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).
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 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
Interventions
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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).
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).
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 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
Eligibility Criteria
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Inclusion Criteria
* 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 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.
20 Years
ALL
No
Sponsors
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University of Medicine and Pharmacy at Ho Chi Minh City
OTHER
Responsible Party
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Bui Pham Minh Man
Doctor of Philosophy
Locations
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Traditional Chinese Medicine faculty - Thống Nhất Hospital
Ho Chi Minh City, , Vietnam
University medical center HCMC branch 3
Ho Chi Minh City, , Vietnam
Countries
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References
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Song 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.
Hawker 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.
Bielewicz J, Daniluk B, Kamieniak P. VAS and NRS, Same or Different? Are Visual Analog Scale Values and Numerical Rating Scale Equally Viable Tools for Assessing Patients after Microdiscectomy? Pain Res Manag. 2022 Mar 29;2022:5337483. doi: 10.1155/2022/5337483. eCollection 2022.
Murakami 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.
Matz PG, Meagher RJ, Lamer T, Tontz WL Jr, Annaswamy TM, Cassidy RC, Cho CH, Dougherty P, Easa JE, Enix DE, Gunnoe BA, Jallo J, Julien TD, Maserati MB, Nucci RC, O'Toole JE, Rosolowski K, Sembrano JN, Villavicencio AT, Witt JP. Guideline summary review: An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spondylolisthesis. Spine J. 2016 Mar;16(3):439-48. doi: 10.1016/j.spinee.2015.11.055. Epub 2015 Dec 8.
Fox 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.
Mao 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.
Hướng 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.
Other Identifiers
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2469/DHYD-HDDD
Identifier Type: -
Identifier Source: org_study_id
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