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CTRI Number  CTRI/2024/05/066646 [Registered on: 01/05/2024] Trial Registered Prospectively
Last Modified On: 09/12/2024
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   Immediate effect of meridian balance method and electro-acupuncture and electro-acupuncture for chronic lower back pain individuals 
Scientific Title of Study   Comparative study of the immediate effect of meridian balance method and electro-acupuncture and electro-acupuncture for chronic lower back pain individuals-a randomized control trail 
Trial Acronym  Balance acupuncture;Electro acupuncture;Back pain ;Acubalm 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR Abitone V R 
Designation  Assistant professor 
Affiliation  SDM College of Naturopathy And Yogic Sciences 
Address  Department of acupuncture,SDMCNYS,Belthangady, Dakshina Kannada, Ujire, Karnataka 574240

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9655976897  
Fax    
Email  abitone.avr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Abitone V R 
Designation  Assistant professor 
Affiliation  SDM College of Naturopathy And Yogic Sciences 
Address  Department of acupuncture, SDMCNYS,Belthangady, Dakshina Kannada, Ujire, Karnataka 574240

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9655976897  
Fax    
Email  abitone.avr@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR Abitone V R 
Designation  Assistant professor 
Affiliation  SDM College of Naturopathy And Yogic Sciences 
Address  Department of acupuncture,SDMCNYS,Belthangady, Dakshina Kannada, Ujire, Karnataka 574240

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9655976897  
Fax    
Email  abitone.avr@gmail.com  
 
Source of Monetary or Material Support  
Shanthivana nature cure hospital 
 
Primary Sponsor  
Name  DR Abitone V R 
Address  Department of acupuncture, SDMCNYS,Belthangady, Dakshina Kannada, Ujire, Karnataka 574240 
Type of Sponsor  Other [self funded] 
 
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 Abitone V R  Shanthivana nature cure hospital,dharmasthala  Department of acupuncture,sdmcnys,ujire,mangalore-574240
Dakshina Kannada
KARNATAKA 		 09655976897

abitone.avr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
sdmcnys  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M51||Thoracic, thoracolumbar, and lumbosacral intervertebral disc disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Electroacupuncture  This group has been treated with the application of acupuncture needles with the help of electric current aka Electroacupuncture(EA).EA group was retained for 20 minutes.It was applied connected to the points BL23, BL27,BL30, BL52 and bilateral GV4.The intensity of stimulation was increased according to comfort of the patient.This procedure lasted about 25 minutes. 
Intervention  MERIDIAN BALANCE METHOD ACUPUNCTURE  STEP 1:Detailed questions are asked from the patient about the location, type, aggravating factor and the severity of pain. The patient is made to sit comfortably on a chair or stool. After assessing the exact location of the pain, Sick meridian is identified either UB or GV meridian. Step 2:consists of choosing the balancing meridian according to the pain in area, for example if pain is in UB meridian, it can be balanced by SI, Heart, kidney or Lung meridians. After choosing the treating meridian the points are selected according to the Mirror Imaging or Reverse mirror Imaging replicating back image on the hands or legs. Tender points are selected and needled (mainly SI 3, SI 4, SI 5). With the combination of Tung’s acupuncture using Lingu, Dabai, Zongbai and Xiabai on opposite hand the patient get relief from pain within 10 seconds of needling. The needle was left retained for 20 minutes. This procedure lasted about 25 minutes. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age 25-70, Both males and females will be included, Preoperative visual analogue scale (VAS) score ≥4, Decreased range of motion, Persistent pain more than 6 months, Independently mobile (with or without aids)
 
 
ExclusionCriteria 
Details  • Developmental spine deformities
• Patients with a history of any psychiatric diseases
• Suspected or confirmed pregnancy
• Rheumatological or neurological diseases
• Recent spinal fractures or back surgery
• Presence of infection, tumors
• Unstable cardiac conditions20
• Body mass index of more than 30

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual Analogue Scale (VAS),McGill Pain Questionnaire,Goniometer, OSWESTRY DISABILITY INDEX, PAIN DISABILITY INDEX,   2 time points(baseline and after 20 minutes) 
 
Secondary Outcome  
Outcome  TimePoints 
Insomnia Severity Index  2 time points(baseline and after 20 minutes) 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   10/04/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This clinical trial aimed to compare the immediate effects of Electroacupuncture and balance meridian acupuncture on chronic back pain patients. The study had a sample size of 80 participants, with 40 individuals in each group. The duration of the treatment was 20 minutes. Assessment tools used in the study included the Visual Analogue Scale (VAS), McGill Pain Questionnaire, Goniometer, Oswestry Disability Index, Pain Disability Index, and Insomnia Severity Index. Data was collected at two-time points - baseline and after 20 minutes of treatment. This study aimed to evaluate the immediate impact of balance meridian acupuncture on pain management and explore the underlying mechanism of the intervention. 
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