| CTRI Number |
CTRI/2024/05/067578 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of threat of Pain and fear of movement following Total Knee replacement in tertiary care hospital in Goa: A Cross - sectional study |
|
Scientific Title of Study
|
Assessment of Pain Catastrophization and Kinesiophobia following Total Knee replacement in tertiary care hospital in Goa: 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 |
Ifat Farooqui |
| Designation |
Masters of Physiotherapy in Musculoskeletal disorders and sports student |
| Affiliation |
Goa Medical College and Hospital, Bambolim |
| Address |
Goa Medical College , Department of Orthopaedics,Allied Health science courses,Tiwari, North Goa
Goa Medical College, Bambolim, Tiswadi, North Goa
North Goa
GOA
403202
India |
| Phone |
9604592332 |
| Fax |
|
| Email |
ifatfarooqui@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Alisha Gracias |
| Designation |
MPT, PhD, Assistant Professor in Physiotherapy |
| Affiliation |
MPT, PhD, Assistant Professor in Physiotherapy |
| Address |
Goa Medical College,Department of Orthopaedics, Allied Health science courses,Tiswadi, Goa
Goa Medical College, Bambolim, Tiswadi, North Goa
North Goa
GOA
403202
India |
| Phone |
9604592332 |
| Fax |
|
| Email |
alishagracias@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ifat Farooqui |
| Designation |
Masters of Physiotherapy in Musculoskeletal disorders and sports student |
| Affiliation |
Goa Medical College and Hospital, Bambolim |
| Address |
Goa Medical College, Department of Orthopaedics, Allied Health science courses, Tiswadi, Goa
Goa Medical College, Bambolim, Tiswadi, North Goa
North Goa
GOA
403202
India |
| Phone |
9604592332 |
| Fax |
|
| Email |
ifatfarooqui@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goa Medical College and Hospital,Department of Orthopaedics, Allied Health science courses, Tiswadi, North Goa,403202 |
|
|
Primary Sponsor
|
| Name |
Ifat Farooqui |
| Address |
Goa medical College and Hospital,Department of Orthopaedics, Allied Health science courses, Tiswadi ,North Goa,403202 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Dr Alisha Gracias |
Goa Medical College and Hospital |
Department of Orthopaedics, Bambolim,Tiswadi,North Goa
North Goa
GOA |
9881887175
alisha.gracias@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Goa Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M17||Osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) All genders
2) Age 45 years to 80 years
3)Participants scheduled for elective unilateral TKR in Goa Medical College and
Hospital.
4)Participants willing to give consent. |
|
| ExclusionCriteria |
| Details |
1)Participants scheduled for revision arthroplasty.
2)Participants scheduled for TKR due to fracture, infection or malignancy
3)Participants who are unable to understand the questionnaires due to cognitive
impairment or neurological disorders.
• Participants with self reported diagnosis of inflammatory conditions like rheumatoid
arthritis, systemic lupus erythrematosis, ankylosing spondylitis.
4)Participants who had previous TKR or any other Lower limb surgery in the past 6
months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To estimate the presence of pain catastrophization and kinesiophobia in participants
following total knee replacement in tertiary care hospital in Goa. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out if any correlation exists between pain catastrophization and kinesiophobia
in participants following total knee replacement. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/05/2024 |
| 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="0"
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
|
No study is done on the assessment of kinesiophobia and pain catastrophization following TKR in Goa. The presence of pain catastrophization and kinesiophobia maybe influenced by the patients demographic variables like age, gender, BMI, educational qualification etc, and also by the type of implant design and surgeons skills which varies from region to region. Therefore. assessment of these will help us to add additional strategies in the rehabilitation of patient which will improve the post-surgical outcome. |