| CTRI Number |
CTRI/2024/06/068739 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
"Perception of illness and its relationship with pain, mobility and function In patients after total knee arthroplasty" |
|
Scientific Title of Study
|
"Perception of illness and its relationship with pain, mobility and function in patients after total knee arthroplasty" |
| Trial Acronym |
Perception of illness |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Nikita Aji |
| Designation |
UG (Bachelor of Physiotherapy) |
| Affiliation |
Father Muller College of Physiotherapy |
| Address |
Father Muller College of Physiotherapy Kankanady Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9446441251 |
| Fax |
|
| Email |
nikitaajiparayil5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Garima Gupta |
| Designation |
Associate Professor |
| Affiliation |
Father Muller College of Physiotherapy |
| Address |
Father Muller College of Physiotherapy Kankanady Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
7897044180 |
| Fax |
|
| Email |
garima.gupta@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Ms Cyanna Joseph Dsouza |
| Designation |
Assistant professor |
| Affiliation |
Father Muller College of Physiotherapy |
| Address |
Father Muller College of Physiotherapy Kankanady Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9019569255 |
| Fax |
|
| Email |
cyannadsouza11@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College Kankanady Mangalore 575002 Karnataka |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| Reshell R Fernandez |
Father Muller Medical College |
Physiotherapy OPD,
Basement 2 , Asha Kiran, Department of Physiotherapy, Father Muller Medical College, Kankanady Mangalore
Dakshina Kannada
KARNATAKA |
9591087356
reshellfernandez6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller institutional ethics committee |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals who have undergone TKA for knee OA and undergoing post-operative rehabilitation
according to the standardised protocols
2. Individuals who can ambulate with or without assistive devices
3. Individuals who are willing to participate |
|
| ExclusionCriteria |
| Details |
1. Individuals with rheumatoid arthritis
2. Individuals undergoing revision surgery
3. Individuals with other musculoskeletal or Neurological impairments that may affect ambulation or those adviced not to weight-bear otherwise
4. Individuals unable to understand the administered questionnaires
5. Individuals who do not give consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Brief illness perception questionnaire(B-IPQ)
Visual analogue scale (VAS)
Timed up and go (TUG) test
Oxford knee score(OKS) |
baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
22/06/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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
|
This cross sectional study aims to determine the relationship between perception of illness and pain in patients following total knee arthroplasty. 32 individuals between 45 -65 years, post total knee arthroplasty (TKA) will be screened for inclusion and exclusion criteria, an informed consent will be obtained from the participants and the study procedure will be explained to the subjects after which measurements of the outcome measures (Brief Illness Perception Questionnaire, Visual Analogue Scale, Time Up and Go test and Oxford Knee Score) will be recorded on the same day. An initial examination including demographic data will be documented. All measurements will be documented on the day of discharge during the hospital stay following the arthroplasty surgery. |