| CTRI Number |
CTRI/2026/01/101272 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Kinesiophobia, Pain and Functional Limitation After Joint Replacement |
|
Scientific Title of Study
|
Relation between Kinesiophobia, Pain and Functional limitation Post Lower Limb Joint Replacement Surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanisha Anish Patel |
| Designation |
Post Graduate Student |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University, Piparia, Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
6353987077 |
| Fax |
|
| Email |
tanisha.6311@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purvi Patel |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University, Piparia, Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9638394494 |
| Fax |
|
| Email |
purvi.cop@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Purvi Patel |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University, Piparia, Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9638394494 |
| Fax |
|
| Email |
purvi.cop@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dhiraj General Hospital, Sumandeep Vidyapeeth Deemed to be University, Piparia, Waghodia, Vadodara, Gujarat, India- 391760 |
| Kothi Sumandeep Hospital, Kothi Road, Opposite Government Press, Anandpura, Vadodara, Gujarat, India- 390001 |
|
|
Primary Sponsor
|
| Name |
Tanisha Anish Patel |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University, Piparia, Waghodia, Vadodara, Gujarat, India- 391760 |
| 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 |
| Tanisha Anish Patel |
Dhiraj General Hospital |
Room No. 20,21,22, Ground Floor, Male and Female Division, Orthopedic Department, Sumandeep Vidyapeeth Deemed to be University, Piparia, Waghodia- 391760
Vadodara
GUJARAT |
6353987077
tanisha.6311@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep vidyapeeth institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M979||Periprosthetic fracture around unspecified internal prosthetic joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Primary hip or knee replacement
Patients admitted for unilateral joint replacement
Both cemented and uncemented arthroplasty |
|
| ExclusionCriteria |
| Details |
Patients with any post arthroplasty complications
Patients with any neurological disorders
Patients with revision arthroplasty
Patients with any psychological dysfunction or noncooperative patients
Patients with either side of musculoskeletal injuries and or surgeries (in last 12 months) and any lower back disorders
Patients with any respiratory disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tampa Scale of Kinesiophobia 17 |
Preoperative, 3rd postoperative day and at 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numerical Pain Rating Scale |
Preoperative, 3rd postoperative day and at 6th week |
| Lower Extremity Functional Scale |
Preoperative, 3rd postoperative day and at 6th week |
|
|
Target Sample Size
|
Total Sample Size="47"
Sample Size from India="47"
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)
|
24/01/2026 |
| 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="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
|
This study aims to evaluate the association between kinesiophobia, pain severity, and functional limitation in patients undergoing lower limb replacement surgeries, including total hip replacement (THR) and total Knee Replacement (TKR). Kinesiophobia, or fear of movement because of pain or the possibility of re-injury may have a negative impact on functional outcomes and postoperative recovery. Patients will be assessed at three time points: preoperatively, on 3rd postoperative day and at 6th week. Kinesiophobia will be assessed using Tampa Scale of Kinesiophobia-17 (TSK-17), pain using Numerical Pain Rating Scale (NPRS), and functional limitation using Lower Extremity Functional Scale (LEFS). The data will be entered in Microsoft Excel, and the results will be calculated. The purpose is to determine relationship between fear of movement, pain levels and functional recovery after surgery which will help in planning targeted rehabilitation strategies to enhance postoperative outcomes. |