| CTRI Number |
CTRI/2025/10/095770 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To identify how Common is Stress and Anxiety Caused by Knee Osteoarthritis Pain |
|
Scientific Title of Study
|
Prevalence of Pain Associated Psychological
Distress among Individuals with Osteoarthritis
of Knee |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalini R |
| Designation |
postgraduate student |
| Affiliation |
Ramaiah college of physiotherapy |
| Address |
Room number 303, 3rd floor, Department of Physiotherapy, Ramaiah Medical College and Hospital, M S Ramaiah Nagar,
MSRIT Post, Bengaluru-560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9481604320 |
| Fax |
|
| Email |
shaliniram199@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ruth Boyle |
| Designation |
Assistant professor |
| Affiliation |
Ramaiah college of physiotherapy |
| Address |
Room number 303, 3rd floor, Department of Physiotherapy, Ramaiah Medical College and Hospital, M S Ramaiah Nagar,
MSRIT Post, Bengaluru-560054
Bangalore
KARNATAKA
560054
India |
| Phone |
09945496325 |
| Fax |
|
| Email |
ruthboyle.rcp@msruas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Ruth Boyle |
| Designation |
Assistant professor |
| Affiliation |
Ramaiah college of physiotherapy |
| Address |
Room number 303, 3rd floor, Department of Physiotherapy, Ramaiah Medical College and Hospital, M S Ramaiah Nagar,
MSRIT Post, Bengaluru-560054
Bangalore
KARNATAKA
560054
India |
| Phone |
09945496325 |
| Fax |
|
| Email |
ruthboyle.rcp@msruas.ac.in |
|
|
Source of Monetary or Material Support
|
| M S Ramaiah University of Applied Science, M S Ramaiah Nagar, MSRIT Post, Bangalore 560054 |
|
|
Primary Sponsor
|
| Name |
Shalini R |
| Address |
Ramaiah College of Physiotherapy, M S
Ramaiah Nagar,
MSRIT Post, Mathikere, Bengaluru-560054 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shalini R |
M S Ramaiah Medical college and Hospitals, Bangalore urban community |
Electrotherapy room number 1, Basement floor, Department of physiotherapy, M S Ramaiah Nagar, MSRIT Post, Bangalore 560054 AND Urban Bangalore
Bangalore
KARNATAKA |
9481604320
shaliniram199@gmail.com |
| Shalini R |
Ramaiah Memorial Hospital |
Electrotherapy room number 2, Basement Floor, Center of Physical Therapy Rehablitation, M S Ramaiah Nagar, MSRIT Post, Bangalore 560054
Bangalore
KARNATAKA |
9481604320
shaliniram199@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M S Ramaiah Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
pain persisting more than 3months with intensity of greater of equal to 4/10 on NPRS scale. Patients diagnosed with osteoarthritis of knee by the ACR (American College of
Rheumatology) criteria OR with radiological findings using Kellgren-Lawrence
grade 1-4 |
|
| ExclusionCriteria |
| Details |
1. Patients receiving active treatment for a psychological condition
2. Acute knee injuries (fractures, ligament tears) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. OSPRO-YF (17item) will be used to screen pain associated
psychological distress |
8 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. WOMAC will be used to assess knee disability
2. NPRS will be used to assess pain intensity
3. IPAQ-SF will used to assess physical activity level |
15 minutes |
|
|
Target Sample Size
|
Total Sample Size="164"
Sample Size from India="164"
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)
|
19/10/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The study is a cross-sectional investigation aiming to determine the prevalence of pain-associated psychological distress among adults with Osteoarthritis of the Knee. The minimum samples to recruit is 164 subjects through convenience sampling in Bangalore Urban, including Ramaiah Hospitals and community settings, between August 2025 and July 2026. Eligible participants must be aged 45 to 85 years, have pain for more than 3 months, be diagnosed with Osteoarthritis of the Knee (ACR criteria or K-L grade 1-4), and report a pain intensity of greater or equal 4/10 on the NPRS. Key outcome measures include the OSPRO-YF (17-item) questionnaire to screen for psychological distress, the WOMAC index for knee disability, the NPRS for pain intensity, and the IPAQ-SF for physical activity level. The results will be analyzed using descriptive statistics to calculate prevalence and confidence intervals, and to examine correlations between pain, OA severity, age, and functional disability. |