FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/081615 [Registered on: 04/03/2025] Trial Registered Prospectively
Last Modified On: 27/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Comparing Dynamic Neuromuscular Stabilization and Conventional Physical Therapy for Pain Relief and Core Strength in Female Students with Primary Dysmenorrhea  
Scientific Title of Study   Assessing the effectiveness of dynamic neuromuscular stabilization exercises versus conventional physical therapy on pain, severity of symptoms and core muscle strength among female students with primary dysmenorrhea 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jaini Naga Harshitha Lakshmi  
Designation  Post - graduate student 
Affiliation  College of Physiotherapy, Dayananda Sagar University  
Address  College of physiotherapy, Dayananda Sagar University Devarakaggalahalli, Harohalli, Kanakapura Main Rd, Kanakapura, Karnataka Department - Physiotherapy department

Bangalore Rural
KARNATAKA
562112
India 
Phone  7075001307  
Fax    
Email  harshithalakshmi25@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sri Hari Sharma 
Designation  Associate Professor  
Affiliation  College of Physiotherapy, DSU 
Address  College of physiotherapy, Dayananda Sagar University,Devarakaggalahalli, Harohalli, Kanakapura Main Rd, Kanakapura, Karnataka Department - Physiotherapy department

Bangalore Rural
KARNATAKA
562112
India 
Phone  9886040520  
Fax    
Email  srihari-physio@dsu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Sri Hari Sharma 
Designation  Associate Professor  
Affiliation  College of physiotherapy, Dayananda Sagar University  
Address  College of physiotherapy, Dayananda Sagar University,Devarakaggalahalli, Harohalli, Kanakapura Main Rd, Kanakapura, Karnataka Department - Physiotherapy department

Bangalore Rural
KARNATAKA
562112
India 
Phone  9886040520  
Fax    
Email  srihari-physio@dsu.edu.in  
 
Source of Monetary or Material Support  
College of physiotherapy, Dayananda Sagar University, Devarakaggalahalli, Harohalli, Kanakapura Road, Ramanagara Dt, 562112 
 
Primary Sponsor  
Name  NILL 
Address  N/A 
Type of Sponsor  Other [NILL] 
 
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 Jaini Naga Harshitha Lakshmi  Dayananda Sagar University   Devarakaggalahalli, Harohalli, Kanakapura Main Rd, Kanakapura, Karnataka 562112
Bangalore Rural
KARNATAKA 		 7075001307

harshithalakshmi25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dayananda Sagar University Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Primary dysmenorrhea  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional physical therapy   To assess the effectiveness of Conventional physical therapy on pain, severity of symptoms and core muscle strength in college students with primary dysmenorrhea for 6 weeks  
Intervention  Dynamic neuromuscular stabilization exercises   To assess the effectiveness of Dynamic neuromuscular stabilization exercises on pain, severity of symptoms and core muscle strength in college students with primary dysmenorrhea for 6 weeks 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  24.00 Year(s)
Gender  Female 
Details  Female students with primary dysmenorrhea with the WALLID Score more than 4.
Nulligravida women
Those who are willing to participate as voluntarily and have signed written informed consent form 
 
ExclusionCriteria 
Details  People diagnosed with Secondary/ congestive dysmenorrhea
Other pelvic pathologies like Endometriosis and Fibroids
Any previous history of gynecological surgeries
People not willing to participate 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Menstrual Symptom Questionnaire  At Baseline and at 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
WaLIDD Score
Muscle activity assessed by Pressure Biofeedback 		 At Baseline & at 6 weeks 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   24/03/2025 
Date of Study Completion (India) 20/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   The study aims to compare the effectiveness of Dynamic Neuromuscular Stabilization (DNS) exercises versus Conventional Physical Therapy (CPT) in managing pain, symptom severity, and core muscle strength in female students with primary dysmenorrhea. Primary dysmenorrhea, characterized by menstrual pain without underlying pelvic pathology, significantly affects quality of life and daily activities. While pharmacological treatments exist, they often have side effects, making non-pharmacological approaches like exercise more favorable. DNS, a technique focusing on core stability through neuromuscular activation, is hypothesized to be more effective than conventional exercises. This randomized comparative study will assess outcomes over six weeks using the Menstrual Symptom Questionnaire, WaLIDD Score, and muscle activity via Pressure Biofeedback, aiming to provide insights into a non-invasive and effective intervention for menstrual pain relief.


 
Close