Evaluating the analgesic effect of Battlefield Acupuncture points on Acute Non-specific Low Back Pain- A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
研究概览
简要总结
The study titled “Evaluating the Analgesic Effect of Battlefield Acupuncture Points on Acute Non-Specific Low Back Pain – A Randomized Controlled Trial” aims to determine whether Battlefield Acupuncture (BFA), a specialized form of auricular acupuncture, can reduce pain and improve function in adults with acute non-specific low back pain (NSLBP). Low back pain is a major global health problem, and existing treatments such as NSAIDs and opioids carry risks. BFA offers a simple, fast-acting, low-cost, and drug-free alternative, but strong evidence—especially in Indian populations—is lacking.
A randomized controlled study will be conducted among 68 participants aged 18–65 years, recruited from the outpatient department of IIYNMS, Chengalpattu. Eligible participants must have NSLBP, no prior acupuncture within 7 days, willingness to participate, and a baseline pain score above 3 on VAS and NRS. Individuals with ear injuries, systemic or psychiatric illnesses, needle phobia, pregnancy, spinal pathology, previous lumbar surgery, or non-spinal causes of pain will be excluded.
Participants will be randomly assigned to either a study group receiving BFA or a control group waitlisted without intervention. The BFA protocol involves applying press needles to five key auricular points—Cingulate Gyrus, Thalamus, Omega 2, Point Zero, and Shenmen—bilaterally, delivered on alternate days for 15 sessions over one month, with each session lasting 30 minutes.
Outcome measurements will be taken at baseline and at 30 days. Primary outcomes include pain intensity using an algometer, Visual Analog Scale (VAS), and Numeric Rating Scale (NRS). Secondary outcomes include functional disability assessed by the Oswestry Disability Index (ODI) and quality of life using the SF-36 questionnaire. Data will be analyzed using SPSS.
Ethical approval will be obtained, and informed consent will be secured from all participants. The study is expected to provide evidence on the effectiveness of Battlefield Acupuncture as a safe, rapid, non-pharmacological intervention for acute non-specific low back pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals aged 18–65 years with non-radicular low back pain and somatically referred pain only, who have not received any acupuncture treatment for at least 7 days prior to study entry, and who are willing to participate, were included in the study.
- •Participants also needed to have a pain score greater than 3 on both the Visual Analog Scale (VAS) and the Numeric Rating Scale (NRS).
排除标准
- •Individuals were excluded if they had open wounds, burns, or scalds on the ear; chronic medical or mental health conditions or needle phobia; or low back pain caused by tumor, infection, inflammatory arthritis, dislocation, fracture, or spondylosis.
- •Participants were also excluded if their symptoms were due to non-spinal conditions such as visceral, vascular, or genitourinary causes, or if they had a history of lumbar surgery.
- •Additional exclusions included nervous system impairment, as well as women who were pregnant or experiencing menstrual bleeding.
研究者
Dr Kaesitha R
International Institute of Yoga and Naturopathy Medical Sciences