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CTRI Number  CTRI/2024/03/064799 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 22/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   The aim of study was to investigate the occurrence of fear of movement in total knee replacement (TKR) and determine the association of fear of movement with established outcome measures.  
Scientific Title of Study   To Analyse The Influence Of Kinesiophobia On Pain And Physical Function Among Total Knee Replacement Patients 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhargavi  
Designation  Mpt Orthopaedics And Traumatology 
Affiliation  Sri Ramachandra Institute Of Higher Education And Research 
Address  No 1 ramachandra nagar porur chennai-600116 Tamilnadu
No 1 ramachandra nagar porur chennai-600116 Tamilnadu
Chennai
TAMIL NADU
600116
India 
Phone  8248653417  
Fax    
Email  t0222008@sriher.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Geetha Haripriya 
Designation  Assistant Professor  
Affiliation  Sri Ramachandra Institute Of Higher Education And Research 
Address  Faculty Of Physiotherapy Department Of Physiotherapy Sri Ramachandra Institute Of Higher Education And Research Chennai-116
No 1 ramachandra nagar porur chennai-600116 Tamilnadu
Chennai
TAMIL NADU
600116
India 
Phone  7358580685  
Fax    
Email  Geethaharipriya@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Bhargavi 
Designation  Mpt (Orthopeadice And Traumatology) 
Affiliation  Sri Ramachandra Institute Of Higher Education And Research 
Address  Sri Ramachandra Institue Of Higher Education And Rsearch No 1 Ramachandra Nagar Porur Chennai
Sri Ramachandra Institue Of Higher Education And Rsearch No 1 Ramachandra Nagar Porur Chennai-600116
Kancheepuram
TAMIL NADU
600116
India 
Phone  7358580685  
Fax    
Email  t0222008@sriher.edu.in  
 
Source of Monetary or Material Support  
Sri Ramachandra Institue Of Higher Education And Rsearch 
 
Primary Sponsor  
Name  Self 
Address  Sri Ramachandra Institute Of Higher Education And Rsearch 
Type of Sponsor  Research institution and hospital 
 
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 
Bhargavi  Sri Ramachandra Institute Of Higher Education And Research  Sri Ramachandra Institute Of Higher Education And Research No,1 Ramachandra Nagar,Porur,Chennai-116
Chennai
TAMIL NADU 
8248653417

t0222008@sriher.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE FOR STUDENTS PROJECTS DHR/ICMR REG NO: EC/NEW/INST/2023/TN/0321  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 
Intervention  NA  NA 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  The Patient planned for total knee replacement (In this study, the patient who undergone TKR).
Both genders included
Age range between 50 to 75.
 
 
ExclusionCriteria 
Details  Patients with other knee injuries and soft tissue injury, knee fractures
Cognitive impairment
Previous lower limb surgery
Neurological conditions with lower extremity
Cardiac and pulmonary infection problems
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
tampa scale of kinesiophobia  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
kOOS knee injury and osteoarthritis outcome score  3 months 
 
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)   01/04/2024 
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="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  

  Total knee replacement is a common orthopedic surgery that involve the articular surfaces (femoral condyles and tibial plateau) of knee joint. In India people who have undergone total knee replacement is 5 lakh and many studies shows prevalence that Total Knee Replacement in India 90-95%. The number of total knee replacements is expected to increase as the average age of the population increases, which highlights the associated future economic burden. Fear of movement represents as a specific fear of physical movement and activity that is wrongly assumed to cause pain, injury or reinjury. It is an excessive, irrational and debilitating fear of physical movement and activity resulting from a feeling of vulnerability to painful injury or reinjury called kinesiophobia. Patients with kinesiophobia believe that movement will cause re-injury and additional pain, therefore kinesiophobia is a risk factor for persistent pain.  It is pointed out that people who suffer fear from movement can develop certain pattern of behavior called fear-avoidance because of people avoid particular movements and activities. After a long period of time, fear-avoidance behavior can lead to the loss of function and disability. As much as 25% of all knee arthroplasty patients show elevated levels of fear of movement.Previous research has also highlighted that 60% of increase in pain score could be related to the presence of kinesiophobia.

 
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