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CTRI Number  CTRI/2025/12/098679 [Registered on: 08/12/2025] Trial Registered Prospectively
Last Modified On: 08/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Testing Whether Battlefield Acupuncture Method Can Relieve Sudden Low Back Pain. 
Scientific Title of Study   Evaluating the analgesic effect of Battlefield Acupuncture points on Acute Non-specific Low Back Pain- A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kaesitha R 
Designation  PG Scholar 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  Department of Naturopathy and Yoga – Division of Branch III (Acupuncture and Energy Medicine), International Institute of Yoga and Naturopathy Medical Sciences 184/4 Kamarajar Nagar, Vallam Chengalpattu, Tamil Nadu

Kancheepuram
TAMIL NADU
603001
India 
Phone  7708811812  
Fax    
Email  kaesitharagupathi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Geethanjali S 
Designation  Head of Department(i/c) 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  Department of Naturopathy and Yoga – Division of Branch III (Acupuncture and Energy Medicine), International Institute of Yoga and Naturopathy Medical Sciences 184/4 Kamarajar Nagar, Vallam Chengalpattu, Tamil Nadu

Kancheepuram
TAMIL NADU
603001
India 
Phone  6379377297  
Fax    
Email  drgeethu.nat007@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Geethanjali S 
Designation  Head of Department(i/c) 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  Department of Naturopathy and Yoga – Division of Branch III (Acupuncture and Energy Medicine), International Institute of Yoga and Naturopathy Medical Sciences 184/4 Kamarajar Nagar, Vallam Chengalpattu, Tamil Nadu

Kancheepuram
TAMIL NADU
603001
India 
Phone  6379377297  
Fax    
Email  drgeethu.nat007@gmail.com  
 
Source of Monetary or Material Support  
International Institute of Yoga and Naturopathy Medical Sciences,Chengalpattu,Tamil Nadu,India.Pincode-603001  
 
Primary Sponsor  
Name  Dr Kaesitha R 
Address  International Institute of Yoga and Naturopathy Medical Sciences 184/4 Kamarajar Nagar Chengalpattu Vallam Tamilnadu 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kaesitha R  International Institute of Yoga and Naturopathy Medical Sciences  Department of Naturopathy and Yoga – Division of Branch III (Acupuncture and Energy Medicine), International Institute of Yoga and Naturopathy Medical Sciences 184/4 Kamarajar Nagar, Vallam Chengalpattu, Tamil Nadu
Kancheepuram
TAMIL NADU 
07708811812

kaesitharagupathi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee International Institute of Yoga and Naturopathy Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M545||Low back pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Battlefield Acupuncture  The press needles of 3×3mm will be inserted in the Auricle on bilateral upto 0.3 mm perpendicular from the outer part to inwards on which study group gets intervention on every alternate days for 1 month (15 sessions) 30 minutes per session. with the five key points in BFA are the cingulate gyrus, thalamus, omega 2, point zero, and Shen-Men  
Comparator Agent  waitlist  The participants under control group will be waitlisted without any intervention  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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). 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Algometer, Visual Analog Scale, Numeric Rating Scale   1 month  
 
Secondary Outcome  
Outcome  TimePoints 
Oswestry Disability Index, Quality of life - Study Questionnaire Short Form 36 Health Survey   every alternate days for 1 month 30 minutes per session 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kaesitharagupathi@gmail.com].

  6. For how long will this data be available start date provided 15-10-2027 and end date provided 31-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

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.

 
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