| CTRI Number |
CTRI/2024/03/064336 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Longwave Diathermy with Foot Muscle Exercise in Plantar Fasciitis |
|
Scientific Title of Study
|
Efficacy of Longwave Diathermy along with Intrinsic Foot Muscle Exercise in 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 |
Simran |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
8307819719 |
| Fax |
|
| Email |
simuarora1412@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha PT |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar of University of Science and TECHnology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
8221966939 |
| Fax |
|
| Email |
ushasportsphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Usha PT |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar of University of Science and TECHnology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
8221966939 |
| Fax |
|
| Email |
ushasportsphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Simran BPT Student Department of Physiotherapy Guru Jambheshwar of Science and Technology Hisar |
|
|
Primary Sponsor
|
| Name |
Simran |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar |
| 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 |
| Dr Usha |
Department of Physiotherapy |
Room no. 5, Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA |
08307819719
ushasportsphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical Committee, Department of Physiotherapy, GJUST |
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 |
| Comparator Agent |
Control Group |
Patient in this group will perform Intrinsic Foot Muscle Exercise for 3 times a week for 4 weeks. |
| Intervention |
Longwave Diathermy along with Intrinsic Foot Muscle Exercise |
Patient in this group will perform Intrinsic Foot Muscle Exercise alon with application of Longwave Diathermy for 3 times a week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patient having pain in the morning with the 1st step.
Tenderness on the medial calcaneus and symptoms worst at 1st step |
|
| ExclusionCriteria |
|
|
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 |
Pain will be assessed by numeric pain rating scale
Foot Function will be measured by foot function index questionnaire |
The outcome will be assessed for 2 times which is at the baseline and after the 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Balance : star excursion balance test |
The outcome will be assessed for 2 times which is at the baseline and after the 4 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)
|
27/03/2024 |
| 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="28" |
|
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 randomised controlled trial with a duration of 4 weeks and involving 30 patients that will be divided into two groups based on the lottery method. It’s intervention involves longwave Diathermy along with intrinsic foot muscle exercise and intrinsic foot muscle exercise in control group. The patients will be informed about the study and written consent will be taken. First each patients demographic information including age, height, weight will be gathered as a baseline data.Preintervention measurements of outcome variables including pain, foot function and balance will be taken. Intervention will be given for 4 weeks then post intervention data of all outcome variables will be taken. |