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CTRI Number  CTRI/2025/08/092147 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 31/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of Core Stability Exercises versus Traditional Postnatal Exercises on Low Back Pain among lactating mothers 
Scientific Title of Study   Effectiveness of Core Stability Exercises versus Traditional Postnatal Exercises on Low Back Pain, Postpartum Depression and Quality of Life among Lactating Mothers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Soundarya M 
Designation  Research Scholar 
Affiliation  Vels Institute of Science and Technology and Advanced Studies 
Address  ROOM NO PHY214 school of Physiotherapy Department of obstetrics and gynecology Physiotherapy Vels Institute of Science and Technology and Advanced Studies VISTAS Thalambur Division Chennai

Kancheepuram
TAMIL NADU
600130
India 
Phone  9952516771  
Fax    
Email  soundaryamugun@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandhya M 
Designation  Assistant Professor and Research Supervisor  
Affiliation  Vels Institute of Science and Technology and Advanced Studies 
Address  ROOM NO PHY214 school of Physiotherapy Department of obstetrics and gynecology Physiotherapy Vels Institute of Science and Technology and Advanced Studies VISTAS Thalambur Division Chennai

Kancheepuram
TAMIL NADU
600130
India 
Phone  9940583928  
Fax    
Email  sandhiya.sp@vistas.ac.in  
 
Details of Contact Person
Public Query  
Name  Soundarya M 
Designation  Research Scholar 
Affiliation  Vels Institute of Science and Technology and Advanced Studies 
Address  ROOM NO PHY214 school of Physiotherapy Department of obstetrics and gynecology Physiotherapy Vels Institute of Science and Technology and Advanced Studies VISTAS Thalambur Division Chennai

Kancheepuram
TAMIL NADU
600130
India 
Phone  9952516771  
Fax    
Email  soundaryamugun@gmail.com  
 
Source of Monetary or Material Support  
Shri Ishri Velan Mission Hospital OPD ROOM Ground Floor Thalambur Chennai 600130 Tamil Nadu India  
 
Primary Sponsor  
Name  Soundarya M 
Address  ROOM NO PHY214 School of Physiotherapy Department of obstetrics and Gynecology Physiotherapy Vels Institute of Science and Technology and Advanced Studies VISTAS Thalambur Division chennai 600130 india 
Type of Sponsor  Other [self] 
 
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 Shiden Kumar TK  Shri Isari Velan Mission Hospital   OPD Room Ground Foor Thalambur Chennai 600130 Tamil nadu India
Kancheepuram
TAMIL NADU 		 7306371288

dr.shidenkumartk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VISTAS SPS IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  lactating mothers with low back pain 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Core Stability Exercises  each exercise was done for 40 minutes per day for 3 alternate days per week for 12 weeks 
Comparator Agent  Traditional Postnatal Exercises  each exercise was done for 40 minutes per day for 3 alternate days per week for 12 weeks 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  All post partum women greater than 3 months
Women pointing low back pain in body chart
Breast feeding Primiparous mothers
Both Caesarean and vaginal delivery
VAS Scale 4 to 7
Women between age group 25 to 35 years
 
 
ExclusionCriteria 
Details  Radiculopathy
Known case of systemic diseases gynaecological problems
Spinal conditions such as Spondylolisthesis
Spinal Fracture
Congenital or spinal deformities psychiatric illness
Any previous or abdominal surgery except caesarean section
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Oswestry Disability Index
Visual analog Scale

 		 12 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Edinburgh Postnatal Depression Scale
World Health Organization Quality Of Life Brief
Maternal Breastfeeding Evaluation Scale 		 12 weeks 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   28/08/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary  

with the informed consent the subjects will be explained about the study and made understood. The subjects will be selected under inclusion and exclusion criteria and divided into two groups. Group will be divided as Experimental group A (n=45) and Experimental group B (n=45)

Experimental Group A, undergoes intervention of core stability exercises and Experimental group B undergoes intervention of Traditional postnatal exercises along with the postural guidance and lactating guidance for both the groups. The session will undergo with my supervision for 3 days per week for 12 weeks, the subjects allowed to take break when they feel discomfort. The re assessment will be taken when the session got end. 

 
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