| CTRI Number |
CTRI/2025/03/082010 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Effect of Foot Exercises and Taping technique on Foot Pain. |
|
Scientific Title of Study
|
Comparative Effect of Foot Core Exercises and Kinesiotaping on Pain and Functional Outcomes in Patients with Plantar Fasciitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Farman Ur Rehman |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana 125001
Hisar
HARYANA
125001
India |
| Phone |
7906892321 |
| Fax |
|
| Email |
farmaanrehman007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shabnam Joshi |
| Designation |
Associate Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana 125001
Hisar
HARYANA
125001
India |
| Phone |
9729922466 |
| Fax |
|
| Email |
shabnamphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shabnam Joshi |
| Designation |
Associate Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana 125001
Hisar
HARYANA
125001
India |
| Phone |
9729922466 |
| Fax |
|
| Email |
shabnamphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Farman Ur Rehman MPT Student Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar 125001 India |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar |
| Address |
Guru Jambheshwar University Science and Technology, Hisar, Haryana, 125001, India |
| Type of Sponsor |
Research institution |
|
|
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 Shabnam Joshi |
Guru Jambheshwar University of Science and Technology |
Room No 05 Department of Physiotherapy OPD GJUS&T Hisar Haryana 125001
Hisar
HARYANA |
9729922466
shabnamphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of GJUS&T |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M722||Plantar fascial fibromatosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Foot Core Exercises, Hotpack and Ultrasound |
Patients in this group will perform Foot Core Exercises, Hot Pack and Ultrasound for five sessions per week for six weeks |
| Comparator Agent |
Kinesiotaping, Hotpack and Ultrasound |
Patients in this group will receive Kinesiotaping, Hot Pack and Ultrasound for five sessions per week for six weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Both Male and Female
Ability to visit hospital for treatment
Unilateral heel pain
Positive Windlass test
Pain on palpation of medial calcaneal tubercle |
|
| ExclusionCriteria |
| Details |
Below the age of 18 years
History of systemic disease
Skin conditions
Foot disorders such as Arthritis, Tumor, Osteoporosis, Severe vascular disease
History of foot surgery
Corticosteroid injection for plantar fasciitis within the previous 6 months
Bilateral Plantar Fasciitis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Foot Posture Index
Foot Function Index
Visual Analog Scale |
The outcome will be assessed for two times
which is at the baseline and after the 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Q angle
Hamstring tightness |
The outcome will be assessed for two times
which is at the baseline and after the 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/03/2025 |
| 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="1"
Days="12" |
|
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
|
It is a randomized controlled trial with a duration of 6 weeks and involving 30 patients that will be divided into two groups based on the lottery method. Its intervention involves Foot core exercises, hot pack and ultrasound in one group and Kinesiotaping, hot pack and ultrasound in second group. The patients will be informed about the study and written informed consent will be taken. First, each patient’s demographic information including age, height and weight will be gathered as a baseline data. Pre- Intervention measurements of outcome variables including VAS, FPI, FFI, Q angle, Hamstring tightness will be taken. Intervention will be given for 6 weeks and then post-intervention data of all the outcome variables will be taken. |