| CTRI Number |
CTRI/2025/07/092089 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
|
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Research on the Incidence of a Common Knee Pain (PFPS) Among Homemakers. |
|
Scientific Title of Study
|
PREVALENCE OF PATELLOFEMORAL PAIN SYNDROME IN HOUSEWIVES OF EAST NAGPUR REGION BETWEEN AGE 30 TO 40 YEARS |
| Trial Acronym |
PFPS-HOME |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akansha Sonkusare |
| Designation |
Intern Datta student, Meghe College of Physiotherapy Nagpur |
| Affiliation |
|
| Address |
Inter student, Department of Physiotherapy
Datta Meghe College of Physiotherapy
Shri Datta Meghe polytechnic Campus Wanadongari Hingna Road Nagpur
Nagpur MAHARASHTRA 441110 India |
| Phone |
9322351824 |
| Fax |
|
| Email |
sonkusareakansha1122@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Akansha Sonkusare |
| Designation |
Physiotherapy Intern Student |
| Affiliation |
|
| Address |
Physiotherapy Intern Student, Department of Physiotherapy
Datta Meghe College of Physiotherapy
Shri Datta Meghe polytechnic Campus Wanadongari Hingna Road Nagpur
Nagpur MAHARASHTRA 441110 India |
| Phone |
9322351824 |
| Fax |
|
| Email |
sonkusareakansha1122@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Akansha Sonkusare |
| Designation |
Physiotherapy Intern Student |
| Affiliation |
|
| Address |
Department of Physiotherapy
Datta Meghe College of Physiotherapy
Shri Datta Meghe polytechnic Campus Wanadongari Hingna Road Nagpur
Nagpur MAHARASHTRA 441110 India |
| Phone |
9322351824 |
| Fax |
|
| Email |
sonkusareakansha1122@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Datta Meghe College of Physiotherapy Nagpur |
| Address |
Shri Datta Meghe Polytechnic Campus Wanadongari Hingna road Nagpur 441110 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Akansha Sonkusare |
Datta Meghe College of Physiotherapy Nagpur |
Musculoskeletal OPD, Ground floor Department of Musculoskeletal sciences
Datta Meghe College of Physiotherapy
Shri Datta Meghe polytechnic Campus Wanadongari Hingna Road Nagpur
441110 Nagpur MAHARASHTRA |
9322351824
akanshasonkusare1122@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe College of Physiotherapy Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M222||Patellofemoral disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Only housewives of East Nagpur region are taken.
2. The housewives involved between 30 to 40 years age only.
3. Females who are willing to participate in this study. |
|
| ExclusionCriteria |
| Details |
1. Females having recent knee fracture.
2. Females who are obese.
3. Playing any sports
4. Having neurological injury.
5. Subluxated patella. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| THE KUJALA PATELLOFEMORAL SCORING SCALE |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="334" Sample Size from India="334"
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)
|
11/08/2025 |
| 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="0" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 primary purpose of this study is to estimate the prevalence of Patellofemoral Pain Syndrome (PFPS) among housewives aged 30 to 40 years residing in the East Nagpur region. The study aims to identify the proportion of women in this demographic experiencing anterior knee pain suggestive of PFPS and to explore potential contributing factors such as physical activity levels, BMI, and daily household workload.
Hypothesis: A significant proportion of housewives aged 30–40 years in East Nagpur experience patellofemoral pain due to repetitive knee-loading activities associated with household chores and sedentary lifestyle factors. |