| CTRI Number |
CTRI/2026/02/102871 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
27/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
profiling |
| Study Design |
Other |
|
Public Title of Study
|
Knee osteoarthritis pain is not just a joint problem it is also a brain, nerve, and mindset problem and this study helps identify which patients need a more holistic approach. |
|
Scientific Title of Study
|
Profiling of central sensitization and pain catastrophizing in patients 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 |
Shivani Upasani |
| Designation |
Post graduate student |
| Affiliation |
Manipal Academy of Higher Eduacation |
| Address |
Upper
Basement, Department of Physiotherapy, Manipal Hospital, No. 98,
Rustam Bagh, Old Airport Road, Bangalore, Karnataka
Bangalore
KARNATAKA
560017
India
Bangalore
KARNATAKA
560017
India |
| Phone |
7020780441 |
| Fax |
|
| Email |
shivaniupasani3012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karvannan H |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal Hospital No. 98, HAL, Old Airport
Road, Bangalore, KARNATAKA 560017, India
KARNATAKA
560017
India
Bangalore
KARNATAKA
560017
India |
| Phone |
9986565966 |
| Fax |
|
| Email |
karvannan.h@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karvannan H |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal Hospital No. 98, HAL, Old Airport
Road, Bangalore, KARNATAKA 560017, India
KARNATAKA
560017
India
Bangalore
KARNATAKA
560017
India |
| Phone |
9986565966 |
| Fax |
|
| Email |
karvannan.h@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shivani Upasani |
| Address |
Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport
Road, Bangalore Bangalore KARNATAKA 560017 India Bangalore
KARNATAKA 560017 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Shivani Upasani |
Manipal Hospital |
Upper
Basement, Department of Physiotherapy, Manipal Hospital, No. 98,
Rustam Bagh, Old Airport Road, Bangalore, Karnataka
Bangalore
KARNATAKA
560017
India
Bangalore
KARNATAKA |
07020780441
shivaniupasani3012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shivani Upasani |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosis with OA knee since 1 year |
|
| ExclusionCriteria |
| Details |
1.Diagnosed psychological condition.
2.Peripheral vascular disease
3.Other medical conditions (cancer, spinal cord injury, multiple sclerosis, fibromyalgia & other neurological pain disorders)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Central Sensitization Inventory.
Pain Catastrophizing Scale.
DN4-QUESTIONNAIRE
Tampa Scale for Kinesiophobia.
|
Immediate Observation only at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tampa Scale for Kinesiophobia |
Immediate observation only at baseline |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
27/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/02/2026 |
| 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)
Modification(s)
|
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
|
Knee Osteoarthritis pain is influenced not only by joint damage but also by altered pain processing and psychological factors. This study profiles the central sensitization and pain catastrophizing in knee Osteoarthritis patients and examines their relationship with fear of movement Kinesiophobia, aiming to support more personalized and effective rehabilitation strategies. |