| 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
|
|
|
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
|
|
|
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 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 englishEXCLUSION 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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