| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kaesitharagupathi@gmail.com].
- 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.
- 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. |