| CTRI Number |
CTRI/2024/01/061538 [Registered on: 16/01/2024] Trial Registered Prospectively |
| Last Modified On: |
11/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The Association of Foot Arch Variations with Patellofemoral Pain Syndrome in Recreational Athletes |
|
Scientific Title of Study
|
The Association of Foot Arch Variations with Patellofemoral Pain Syndrome in Recreational Athletes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankit Gudi |
| Designation |
PG Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Second Floor, Room No. 22, Kasturba Medical College Hospital, Attavar, Mangalore, Dakshin Kannada Karnataka- 575001 India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8329752817 |
| Fax |
|
| Email |
ankit.kmcmlr2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Ashish John Prabhakar |
| Designation |
Assistant Professor- Selection grade |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Fifth floor, KMC Hospital, Ambedkar Circle, Mangalore, Dakshin Kannada Karnataka- 575001 India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8123223092 |
| Fax |
|
| Email |
ashish.john@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mr Ashish John Prabhakar |
| Designation |
Assistant Professor- Selection grade |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Fifth floor, KMC Hospital, Ambedkar Circle, Mangalore, Dakshin Kannada Karnataka- 575001 India
KARNATAKA
575001
India |
| Phone |
8123223092 |
| Fax |
|
| Email |
ashish.john@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Mangalore |
|
|
Primary Sponsor
|
| Name |
KMC Hospital Department of Physiotherapy |
| Address |
Department of Physiotherapy, Fifth floor, KMC Hospital, Ambedkar Circle, Mangalore, KARNATAKA, India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Ankit Gudi |
KMC Hospital |
Department of
Physiotherapy, Second
Floor, Room No. 22,
Kasturba Medical
College Hospital,
Attavar, Mangalore,
KARNATAKA 575004
India
Dakshina Kannada
KARNATAKA |
8329752817
ankit.kmcmlr2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, KMC, Mangalore. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M222||Patellofemoral disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Recreational athletes clinically diagnosed with PFPS by an orthopaedician.
Pain provoked by at least 2 activities from running, walking, hopping, squatting, stair climbing, kneeling, or prolonged sitting.
Positive Clarkes sign. |
|
| ExclusionCriteria |
| Details |
Concomitant injury or pain arising from the lumbar spine or hip, knee internal derangement.
Knee meniscal or ligament injury in past 3 months.
Previous knee surgery.
Early OA. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Foot Arch Index |
Foot Arch Index at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
22/01/2024 |
| 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 Yet Recruiting |
| 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 explore the association of foot arch variations with Patellofemoral Pain Syndrome in recreational athletes. Participants with patellofemoral pain syndrome will be assessed for foot arch variations (i.e. flat foot, normal arch foot and high arched foot) and compared with participants who do not have patellofemoral pain syndrome. This study will further check the association between patellofemoral pain syndrome and foot arch variations. |