| CTRI Number |
CTRI/2024/05/067771 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Finding the Impact of Patellofemoral Pain on Q-Angle in Adult Housewives While performing Their Daily Functional Activities. |
|
Scientific Title of Study
|
Impact of patellofemoral pain on Q angle & functional capacity in adult housewives: A cross-sectional study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Sharma |
| Designation |
BPT Student |
| Affiliation |
Galgotias University |
| Address |
Department of Physiotherapy , Galgotias University
Plot No. 2, Yamuna Expy, Opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Department of Physiotherapy , Galgotias University
Plot No. 2, Yamuna Expy, Opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7827044483 |
| Fax |
|
| Email |
aditisharma6764@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditi Sharma |
| Designation |
BPT Student |
| Affiliation |
Galgotias University |
| Address |
Department of Physiotherapy , Galgotias University
Plot No. 2, Yamuna Expy, Opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Department of Physiotherapy , Galgotias University
Plot No. 2, Yamuna Expy, Opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
|
| Fax |
|
| Email |
aditisharma6764@gmail.COM |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sakshi Arora |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Department of Physiotherapy ,
Galgotias University
Plot No. 2, Yamuna Expy,Opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Department of Physiotherapy ,
Galgotias University
Plot No. 2, Yamuna Expy,Opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
North East
DELHI
203201
India |
| Phone |
9717681868 |
| Fax |
|
| Email |
sakshi.arora@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Physiotheraphy, Galgotias University |
|
|
Primary Sponsor
|
| Name |
Aditi Sharma |
| Address |
Department of Physiotherapy, Galgotias University |
| Type of Sponsor |
Other [] |
|
|
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 |
| Aditi Sharma |
Department of Physiotherapy, Galgotias University |
Department of Physiotheraphy , Galgotias University, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
7827044483
110094
aditisharma6764@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z728||Other problems related to lifestyle, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients complaining of anterior knee pain during sitting more than 2 hours.
2. Pain during palpation of patella.
3. Individual with chronic knee pain( more than 2-3 months )
4. Adult housewives between the age of 25-45 years.
5. Positive sign while performing either or all special test- McConnell test, patellofemoral grind test.
6.Pain during stair ascend and descend.
7.Pain while performing squats and running. |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from osteoarthritis.
2. Patients having tendonitis due to the overuse of joint.
3. Patients having Meniscus injury.
4. Patients having congenital abnormalities.
5. Patients who are overweight.
6. Injuries around the soft tissue of knee.
7. Inflammation of soft tissues of knee (bursitis).
8. Individuals before and after the pregnancy.
9. Patients having muscle weakness (hamstring, quadriceps).
10. Patients with fractures and knee surgery.
11. Trauma due to sudden fall or forceful twisting. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Kujala Score / Anterior knee pain. |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| KOS-ADL (knee outcome survey -activity of daily living) |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Patellofemoral pain is also know as "Runner knee or Anterior knee pain" in adult housewives . In anterior knee discomfort involving the patella and retinaculum. The sign and symptoms affect patients activities like running, kneeling, squatting, climbing stairs etc.. Most common characterized frequently by people are the sound are Knee Crepitus in PFP peoples like an audible grinding sound or felt vibrations during knee motion. The methods we are going to use are the questionnaire regarding knee that also affect the functional capacity of doing daily living activity and also occur slight changes of their Q- angle to prevent themselves from the sharp shooting pain on their knee. Questionnaire like Kujala score /Anterior knee pain and KOS-ADL ( knee outcome survey -activity of daily living ) that shows the severity of pain they are having in their day to day life. The data will be collected according to the inclusion criteria like pain during palpation of patella, stairs ascend and descend ,and pain more than 2-3 months. The study will be conducted over the 50 adult housewives of East Delhi housewives with the age group of 25-45 years. The sample size are calculated through G - power software. After that data will be analyzed through statistical test. |