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CTRI Number  CTRI/2026/03/106073 [Registered on: 12/03/2026] Trial Registered Prospectively
Last Modified On: 11/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   How fear of movement affects pain, knee joint awareness and physical function in people with one-sided knee osteoarthritis. 
Scientific Title of Study   Correlation of kinesiophobia with knee pain intensity, joint position sense and functional performance in individuals with unilateral knee osteoarthritis- 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  Dr Swati Kubal 
Designation  Assistant Professor 
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital 
Address  OPD 24, Physiotherapy Department, PT School and Centre, Topiwala National Medical College and Dr B.Y.L. Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central.

Mumbai
MAHARASHTRA
400008
India 
Phone  8691948255  
Fax    
Email  swatikubal@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swati Kubal 
Designation  Assistant Professor 
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital 
Address  OPD 24, Physiotherapy Department, PT School and Centre, Topiwala National Medical College and Dr B.Y.L. Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central.

Mumbai
MAHARASHTRA
400008
India 
Phone  8691948255  
Fax    
Email  swatikubal@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Divya Karkera 
Designation  MPT 1 
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital 
Address  OPD 24, Physiotherapy Department, PT School and Centre, Topiwala National Medical College and Dr B.Y.L. Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central.

Mumbai
MAHARASHTRA
400008
India 
Phone  7045649737  
Fax    
Email  divyakarkera99@gmail.com  
 
Source of Monetary or Material Support  
P.T. School & Centre, Topiwala National Medical College and B.Y.L.Nair Charitable Hospital, Mumbai Central, Mumbai-400008, Maharashtra, India. 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Swati Kubal  P.T School and Centre, Topiwala National Medical College and B.Y.L Nair Charitable Hospital  OPD 24, Physiotherapy Department, PT School and Centre, Topiwala National Medical College and Dr B.Y.L. Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai- 400008
Mumbai
MAHARASHTRA 
8691948255

swatikubal@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Academic Research Projects (ECARP) PG Academic Committee T.N. Medical College and B.Y.L. Nair Ch Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Individuals with the age group from 40-60 years
2) Chronic knee pain equal to or more than 3 months (VAS less than 7)
3) Individuals who were radiologically confirmed for the presence of osteoarthritic changes in Unilateral Tibio-femoral joint (Kellgren – Lawrence grade 2-3)
4) Individuals who are able to walk at least 100 m.
5) Individuals who are able to understand and follow the commands of the examiner.
6) Literate Individuals willing to participate.
 
 
ExclusionCriteria 
Details  1) Participants having previous history of meniscal or ligament injury or surgery to the lower extremities.
2) History of any severe systemic disease (heart disease, metabolic or inflammatory arthritis)
3) History of any severe musculoskeletal (except Osteoarthritis) or neurological disease (e.g. Parkinson’s, Alzheimer’s, peripheral neuropathy, etc.)
4) Infiltration corticosteroids in the knees in the last six months.
5) History of diabetes. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Kinesiophobia score measured using Tampa Scale of Kinesiophobia (TSK)  At a single assessment session (baseline) 
 
Secondary Outcome  
Outcome  TimePoints 
1)pain intensity measured using Visual Analogue Scale (VAS)
2)Joint position error (in degrees) measured using a universal goniometer
3)functional performance measured using 30s chair stand test (number of repetitions) and 40m Fast paced walk test (time in seconds) 
At the same single assessment session (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)   24/03/2026 
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="6"
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  

NEED OF STUDY

Knee osteoarthritis (KOA) is a significant public health concern in India, where its prevalence is increasing due to a rise in life expectancy, sedentary lifestyles and obesity. Despite advancements in treatment, persistent pain, reduced joint function, and fear of movement often hinder rehabilitation outcomes. Compared to the western population, there is a diverse ethnic, racial and cultural background in the Indian population, which may influence pain perception and kinesiophobia differently. Investigating these factors can help in developing culturally relevant interventions. 

While studies on pain intensity and functional performance exist, there is a lack of data on the impact of kinesiophobia on joint position sense and movement especially in Indian individuals with unilateral knee OA.  Identifying the relationship between kinesiophobia and functional performance can help physiotherapists design more effective treatment protocols to improve mobility and reduce fear-related disability.

The correlation between kinesiophobia, knee pain intensity, joint position sense, and functional performance remain underexplored in the Indian population. Understanding this relationship is crucial for addressing the multidimensional nature of the disease and bridging gaps in rehabilitation strategies, tailored to Indian patients, who often have unique socio-cultural and environmental influences on their physical activity levels and pain management approaches. It will contribute to healthcare policies by emphasizing the need for psychological assessments and movement-based therapies alongside traditional OA management strategies, leading to better clinical outcomes and improved quality of life.

AIM

To determine the correlation of kinesiophobia with knee pain intensity, joint position sense and functional performance in individuals with unilateral knee osteoarthritis.

OBJECTIVES

1) To assess kinesiophobia in individuals with unilateral knee osteoarthritis.

2) To assess pain intensity in affected knee joint in individuals with unilateral knee osteoarthritis.

3) To assess knee joint position sense in individuals with unilateral knee osteoarthritis.

4) To assess the functional performance in individuals with unilateral knee osteoarthritis. 

5) To determine the correlation of kinesiophobia with knee pain intensity, joint position sense and functional performance in individuals with unilateral knee osteoarthritis.

PROCEDURE

Permission from the Departmental Review Board and the Institutional Ethics Committee was sought.

Participants will be enrolled in the study depending on the selection criteria and willingness to participate in the study.

Written informed consent will be taken from the participants.

Participants will be given an information sheet to know the details of the study procedure.

Case record form with demographic details will be filled.

Knee pain intensity will be assessed by Visual Analogue scale, Kinesiophobia by using the TAMPA scale of Kinesiophobia -11 scale, knee joint position sense by using universal goniometer in 30°, 45°, 60° of knee flexion in sitting position and functional performance by using 30s chair stand test and 40m fast paced walk test.

Data will be collected and analyzed.

DATA MANAGEMENT AND ANALYSIS PROCEDURE

All the data obtained from the participants will be kept confidential. The data will be tabulated and stored in Excel sheets for analysis.

Plan for statistical analysis are as follows:

1.     Descriptive statistics will be used to describe participant’s demographic data.

2.     Data will be tested for normality.

3.     If the data passes the normality test, Parametric - Pearson’s correlation test will be used for data analysis.

4.     If the data do not pass the normality test, Non-parametric - Spearman’s correlation test will be used.

The data obtained will be tabulated and analyzed using SPSS software (version- 24). 
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