| 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
|
|
|
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
|
|
|
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. |