| CTRI Number |
CTRI/2024/11/076145 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Assess Knee Pain and Its Risk Factors in Office Workers with a Sitting Lifestyle. |
|
Scientific Title of Study
|
Prevalence and Associated Risk Factors of Patellofemoral Pain Syndrome (PFPS) among Office Workers with Sedentary Lifestyle at Galgotias University - A Survey 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 |
Amrita Garg |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Department of physiotherapy, Galgotias university yamuna expy, opposite Buddha international circuit, sector 17A Greater Noida Uttar Pradesh,
Gautam Buddha Nagar
UTTAR PRADESH
203201
India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8791767496 |
| Fax |
|
| Email |
gargamrita40@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amrita Garg |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Department of physiotherapy, Galgotias university yamuna expy, opposite Buddha international circuit, sector 17A Greater Noida Uttar Pradesh,
Gautam Buddha Nagar
UTTAR PRADESH
203201
India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8791767496 |
| Fax |
|
| Email |
gargamrita40@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanchan Dixit |
| Designation |
Assistant professor |
| Affiliation |
Galgotias University |
| Address |
Department of physiotherapy, Galgotias university yamuna expy, opposite Buddha international circuit, sector 17A Greater Noida Uttar Pradesh,
Gautam Buddha Nagar
UTTAR PRADESH
203201
India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7906645610 |
| Fax |
|
| Email |
kanchan.dixit@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy, Galgotias university Plot no 2 , yamuna expy, opposite Buddha international circuit, sector 17A Greater Noida UTTAR PRADESH India 203201
|
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Department of Physiotherapy Galgotias university Plot no. 2 Yamuna expy opposite Buddha international circuit sector 17A Greater Noida Uttar Pradesh pin code 203201 INDIA |
| Type of Sponsor |
Research institution |
|
|
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 Kanchan Dixit |
Galgotias university |
Department of physiotherapy B315 Gautam bhudh nagar uttar pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
07906645610
kanchan.dixit@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental research committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M224||Chondromalacia patellae, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Office workers with at least 6 months of employment in a sedentary job (defined as
spending at least 70% of their working time seated). 2. No history of knee surgery or significant trauma to the lower extremities in the past
year.
3. Willingness to provide informed consent and participate in the study assessments. |
|
| ExclusionCriteria |
| Details |
1. Individuals with diagnosed knee osteoarthritis, rheumatoid arthritis, or other
inflammatory joint diseases.
2. Participants with neurological disorders affecting lower limb function.
3. Those currently undergoing treatment for knee pain (such as physical therapy or
medication). |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of Patellofemoral Pain Syndrome (PFPS) among office workers
workers with sedentary lifestyle |
1 time study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To examine the relationship between prolonged sitting and PFPS development. |
1 Time study through questionnaire |
|
|
Target Sample Size
|
Total Sample Size="330"
Sample Size from India="330"
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)
|
10/11/2024 |
| 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="2"
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 Syndrome (PFPS), also known as "runner’s knee," is a prevalent musculoskeletal disorder causing pain around or behind the kneecap (patella). PFPS, often associated with athletes, is now being recognized among office workers, a demographic not typically at high risk for such conditions. The increasing prevalence of PFPS among sedentary populations suggests that factors beyond intense physical activity, such as overall lifestyle and physical activity level, may significantly impact its development . The understanding of the link between physical activity levels and the onset of PFPS in office workers is crucial for addressing this health issue in modern workplaces. The study aims to identify the prevalence and associated risk factors of
Patellofemoral Pain Syndrome (PFPS) among office workers with sedentary lifestyle. Sample size is 330 and study needs office workers with age group of 25-55 years. |