Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
Study NCT ID:
NCT06874959
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2025-02-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Pain Relief Effect of Battlefield Acupuncture on Patients With Chronic Low Back Pain Due to Lumbar Spine Degeneration.
Sponsor:
University of Medicine and Pharmacy at Ho Chi Minh City
Organization:
Study Overview
Official Title:
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.
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: