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CTRI Number  CTRI/2025/07/091668 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 31/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   camparison of acupuncture points 
Scientific Title of Study   Electroacupuncture for Low back pain. A comparative study of local versus distal points.  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Annamalai Dharuman 
Designation  PG SCHOLAR 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  faculty block, International institute of yoga and naturopathy medical sciences, kamarajar nagar, thirumani road, Chengalpattu.

Kancheepuram
TAMIL NADU
603001
India 
Phone  09025899710  
Fax    
Email  annamalai.sd@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Geethanjali S 
Designation  Assistant Medical Officer/ Grade II Lecturer 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  faculty block, International institute of yoga and naturopathy medical sciences, kamarajar nagar, thirumani road, Chengalpattu.

Kancheepuram
TAMIL NADU
603001
India 
Phone  09025899710  
Fax    
Email  drgeethu.nat007@gmail.com  
 
Details of Contact Person
Public Query  
Name  Moniccasun 
Designation  PG Scholar 
Affiliation  International Institutte of yoga and naturopathy medical sciences 
Address  faculty block, International institute of yoga and naturopathy medical sciences, kamarajar nagar, thirumani road, Chengalpattu.

Kancheepuram
TAMIL NADU
603001
India 
Phone  9842697489  
Fax    
Email  annamalaibnys@gmail.com  
 
Source of Monetary or Material Support  
International institute of yoga and naturopathy medical sciences, kamarajar nagar, thirumani road, Chengalpattu. Tamilnadu, India- 603001 
 
Primary Sponsor  
Name  Annamalai 
Address  faculty block, International institute of yoga and naturopathy medical sciences, kamarajar nagar, thirumani road, Chengalpattu. Tamilnadu, India 603001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Moniccasun  faculty block, International institute of yoga and naturopathy medical sciences, kamarajar nagar, thirumani road, Chengalpattu. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Annamalai Dharuman  International Institute of Yoga and Naturopathy medical sciences  faculty block, International institute of yoga and naturopathy medical sciences, kamarajar nagar, thirumani road, Chengalpattu.
Kancheepuram
TAMIL NADU 		 09025899710

annamalai.sd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
International Institute of Yoga and Naturopathy Medical Sciences Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M512||Other thoracic, thoracolumbar andlumbosacral intervertebral disc displacement,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Electroacupuncture Distal points  Electro Acupuncture at UB-40 bilaterally in supine lying for 30 minutes. 
Intervention  Electroacupuncture Local points  Electro Acupuncture at UB-23 and UB 25 bilaterally in supine lying for 30 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  The study includes adults aged 18-50 experiencing acute or subacute non-specific low back pain, encompassing both males and females who consent to participate in the research. 
 
ExclusionCriteria 
Details  Exclusion criteria include participants with open wounds, burns, or scalds in the specific areas, those who have undergone recent spinal surgeries, individuals with serious medical conditions such as spinal tumors or fractures, those with metal prosthetics inside the body, individuals consuming alcohol or psychotropic medications during the study period, pregnant or breast-feeding women, those participating in other clinical studies, and individuals with a needle phobia. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual analog scale(VAS)  Baseline and after 10 days 
 
Secondary Outcome  
Outcome  TimePoints 
Oswestry Disability Index  Before and after 10 days of intervention. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 2 
Date of First Enrollment (India)   01/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/08/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  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 - Data are available indefinitely at (Link to be included annamalai.sd@gmail.com).

  6. For how long will this data be available start date provided 29-05-2025 and end date provided 30-05-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - annamalaibnys@gmail.com
Brief Summary   Low back pain is a common musculoskeletal condition causing discomfort from the lower border of the 12th rib to the inferior gluteal fold, often leading to functional limitation, disability, and economic burden. It has a global prevalence of 7.10 percent and 64.8 percent in India, with only a portion of affected individuals seeking treatment. Contributing factors include obesity, poor posture, manual labor, and mental health issues. Conventional treatments involve medications like NSAIDs and opioids, which can have adverse effects. As an alternative, acupuncture and electroacupuncture are widely used for pain relief. Electroacupuncture enhances pain modulation by stimulating opioid release and brain activity in pain-related regions. According to Traditional Chinese Medicine, chronic low back pain is related to kidney deficiency, and specific acupuncture points such as UB 23, UB 25, and UB 40 are commonly used. This study aims to compare the effectiveness of electroacupuncture applied to local points UB 23 and UB 25 versus the distal point UB 40. A comparative study will be conducted with 60 participants divided into two groups, receiving treatment for 10 days. Outcomes will be measured using the Visual Analog Scale and Oswestry Disability Index to evaluate pain reduction and functional improvement. 
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