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CTRI Number  CTRI/2024/11/076614 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 18/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Investigating Abdominal and Hip Muscle Weakness in individuals with painful menstruation 
Scientific Title of Study   Prevalence of Core and Hip Muscle Weakness in 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  Manvi Gupta 
Designation  masters of physiotherapy student 
Affiliation  amar jyoti institute of physiotherapy 
Address  Amar Jyoti Institute of Physiotherapy, Musculoskeletal department, Exercise therapy laboratory, 2nd floor, karkardooma, anand vihar

East
DELHI
110092
India 
Phone  7982116817  
Fax    
Email  mgarg972000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Tarun Kumar (PT) 
Designation  assisstant professor 
Affiliation  amar jyoti institute of physiotherapy 
Address  Amar Jyoti Institute of Physiotherapy, Musculoskeletal department, Exercise therapy laboratory, 2nd floor, karkardooma, anand vihar

East
DELHI
110092
India 
Phone  8745802112  
Fax    
Email  physiotarun29@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Manvi Gupta 
Designation  masters of physiotherapy student 
Affiliation  amar jyoti institute of physiotherapy 
Address  Amar Jyoti Institute of Physiotherapy, Musculoskeletal department, Exercise therapy laboratory, 2nd floor, karkardooma, anand vihar

East
DELHI
110092
India 
Phone  7982116817  
Fax    
Email  mgarg972000@gmail.com  
 
Source of Monetary or Material Support  
Amar Jyoti Institute of Physiotherapy, karkardooma, Anand vihar, delhi -110092 
 
Primary Sponsor  
Name  Manvi Gupta 
Address  Amar Jyoti Institute of Physiotherapy, Musculoskeletal department, Exercise therapy laboratory, 2nd floor, karkardooma, anand vihar 
Type of Sponsor  Other [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 Manvi Gupta PT  amar jyoti institute of Physiotherapy  amar jyoti institute of Physiotherapy, Musculoskeletal department, Exercise therapy laboratory, 2nd floor, Karkardooma, anand vihar
East
DELHI 
79821168117

mgarg972000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
amar jyoti institutional review board- ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N944||Primary dysmenorrhea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  Age of subjects between 18 and 25 years
Females with regular menstrual cycle (i.e. 25 to 35 days)
Willing to participate
Working knowledge of english 
 
ExclusionCriteria 
Details  Students not willing to participate
Using pharmacological and non-pharmacological methods of pain relief
Irregular menstrual cycles
History of any gynaecological disorder or secondary dysmenorrhea
History of any musculoskeletal or neurological problems
History of recent fracture, strain and sprain
Who do not indulge in any form of physical activity? 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 core muscle strength measured with pressure biofeedback unit
2 hip muscles strength measured by hand held dynamometer 
one time 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable  not applicable 
 
Target Sample Size   Total Sample Size="384"
Sample Size from India="384" 
Final Enrollment numbers achieved (Total)= "384"
Final Enrollment numbers achieved (India)="384" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/11/2024 
Date of Study Completion (India) 25/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
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
Modification(s)  
BACKGROUND
Primary dysmenorrhea refers to painful menstrual cramps without any underlying medical conditions, characterised by severe lower abdominal discomfort before or during menstruation. Other symptoms may include lower back pain, nausea, vomiting, diarrhoea, headaches, and fatigue, which can interfere with daily activities. While hormonal factors are commonly associated with dysmenorrhea, recent research suggests that musculoskeletal issues, like hip and core muscle weakness and lumbo-pelvic misalignment, may contribute to the condition by affecting uterine positioning and blood flow.  Further, impaired hip and core muscle function may contribute to maladaptive movement patterns and increased pain sensitivity in dysmenorrhea. This study aims to evaluate hip and core weakness in primary dysmenorrhea individuals, utilising objective measures to understand musculoskeletal alterations influencing symptom severity and treatment outcomes. Insights gained can inform tailored exercise programmes and rehabilitation protocols, empowering physiotherapists to provide personalised care and optimise treatment outcomes for dysmenorrhea sufferers.

Needs OF THE STUDY
Dysmenorrhea, the most common gynaecological disorder, is often neglected or mistaken as a normal part of the menstrual cycle, particularly among contemporary females. Due to its significant impact on adolescents and those in their productive years, more research is needed to better understand and manage the condition. Identifying modifiable risk factors can lead to personalised treatment, improving outcomes, and reducing the burden on healthcare systems. While studies have explored the effectiveness of core training on pain and symptom severity in primary dysmenorrhea, research has yet to assess hip and core function before and after intervention, despite evidence of poor abdominal muscle performance in affected individuals.

METHADOLOGY
Study design: A cross-sectional study
Study population: college-going students (age 18-25)
Study setting: Amar Jyoti Institute of Physiotherapy, Karkardooma
Sample size: 384 (slovian formula)
Sampling method: The subjects will be recruited through convenience sampling

INCLUSION CRITERIA:-
 Age of subjects between 18 and 25 years (Kulkarni et al.,2019)
 Females with regular menstrual cycle (i.e. 25 to 35 days) (Jain, 2014)
 Willing to participate
Working knowledge of english

EXCLUSION CRITERIA:-
Students not willing to participate
Using pharmacological and non-pharmacological methods of pain relief
Irregular menstrual cycles
History of any gynaecological disorder or secondary dysmenorrhea 
History of any musculoskeletal or neurological problems
History of recent fracture, strain and sprain
Who do not indulge in any form of physical activity?

OUTCOME MEASURES
  • core strength measurement:  pressure biofeedback machine
A pressure biofeedback machine is a device used to measure core strength and stability by assessing muscle performance and endurance. The machine consists of a pressure sensor and a feedback unit, which typically includes a display screen to show real-time data. This method is non-invasive, easy to use, and provides immediate insights into core muscle function.
  •  Hip muscke strength: hand held dynamometer
A handheld dynamometer is a device used to measure muscle strength, including hip strength, by quantifying the force exerted during muscle contractions. The handheld dynamometer consists of a force sensor and a display unit. The force sensor is placed at the point of contact where muscle strength is to be measured 

PROCEDURE
  • Subject Screening: Eligible subjects will be screened based on the inclusion and exclusion criteria outlined in the study protocol.
  • . Measurements:
a) Core strength using pressure biofeedback and deep muscle contraction test, trunk endurance flexion and extension test

b) Hip muscle strength hand held dynamometer

  • .Data Analysis – Data will be complied and analysed using SPSS version 16.0.0
 
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