| CTRI Number |
CTRI/2025/05/086729 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To find the correlation between pain catastrophizing, kinesiophobia, and pelvic inclination in individuals with knee osteoarthritis. |
|
Scientific Title of Study
|
Correlation between pain catastrophizing, kinesiophobia, and pelvic inclination in individuals with knee osteoarthritis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BHAVYA JAIN |
| Designation |
Physiotherapist |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
J-Block, Manav Rachna Sports Science Center, Department of Physiotherapy(QS-11), Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector-43, Faridabad, Haryana-121004
Faridabad
HARYANA
121004
India |
| Phone |
9599832955 |
| Fax |
|
| Email |
jainb6822@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BHAVYA JAIN |
| Designation |
Physiotherapist |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
J-Block, Manav Rachna Sports Science Center, Department of Physiotherapy(QS-11), Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector-43, Faridabad, Haryana-121004
Faridabad
HARYANA
121004
India |
| Phone |
9599832955 |
| Fax |
|
| Email |
jainb6822@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit Arora |
| Designation |
Associate Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
J-Block, Manav Rachna Sports Science Center, Department of Physiotherapy(QS-11), Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector-43, Faridabad, Haryana-121004
Faridabad
HARYANA
121004
India |
| Phone |
9968975791 |
| Fax |
|
| Email |
Sumit.sports@mriu.edu.in |
|
|
Source of Monetary or Material Support
|
| Manav Rachna International Institute Of Research and Studies, Department Of Physiotherapy(QS-11), J-Block, Manav Rachna Sports Science Center, Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector-43, Faridabad, Haryana-121004 |
|
|
Primary Sponsor
|
| Name |
MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES |
| Address |
Manav Rachna International Institute Of Research and Studies, Department Of Physiotherapy (QS-11), J-Block, Manav Rachna Sports Science Center, Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector-43, Faridabad, Haryana-121004 |
| 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 Sumit Arora |
Manav Rachna International Institute Of Research and Studies |
Manav Rachna International Institute Of Research and Studies, Department Of Physiotherapy(QS-11), J-Block, Manav Rachna Sports Science Center, Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector-43, Faridabad, Haryana-121004
Faridabad
HARYANA |
9968975791
Sumit.sports@mriu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMITEE, MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES |
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 |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Aged between 40-80 years
Both males and females
Pain intensity ranging between 3-7
History of chronic knee pain for at least 6 months.
Physician diagnosed knee OA with X-ray findings
Greater than or equal to grade 2 knee OA according to Kellgren and Lawrence classification
Able to read and write English
|
|
| ExclusionCriteria |
| Details |
Grade 1 Knee OA
Cognitive Impairments
History of any lower limb surgery in the past 2 years
Any other muscular or neurological condition affecting the lower limb
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain Catastrophizing
Kinesiophobia
Pelvic Inclination |
Only At the time of assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain Intensity
Body Mass Index |
Only At the time of assessment |
|
|
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)
|
26/05/2025 |
| 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 Yet Recruiting |
| 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
|
•After
the ethical clearance, patients
diagnosed with knee OA will be screened according to the inclusion and
exclusion criteria.
•Those
who voluntarily participate after signing the informed consent form will be
enrolled in the study. The study details, risks, and benefits will be fully
explained to all participants and the data will be collected from the subjects, starting with the demographic information then self-reported questionnaires for pain catastrophizing, kinesiophobia and pain intensity and then measurement of the pelvic inclination.
•Pain
intensity will be assessed through the Visual Analog Scale(VAS).
•The individuals’ pain catastrophizing will be assessed using the Pain
Catastrophizing Scale (PCS), a 13-question scale.
•Further,
Kinesiophobia will be assessed using the Tampa Scale of Kinesiophobia-11 (TSK-11), consisting of 11 questions.
•And
lastly, the pelvic inclination will be assessed using the pelvic inclinometer to assess the anterior pelvic tilt, posterior pelvic tilt, and the position of the pelvis in neutral.
•After
collecting the data, it will be evaluated, analyzed and results will be generated. |