| CTRI Number |
CTRI/2024/08/071975 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing the pain relief in patients with plantar fasciitis treated with physiotherapy versus corticosteroid injection |
|
Scientific Title of Study
|
comparison of effectiveness of ultrasound therapy with stretching exercises vs steroid injection in the treatment of plantar fasciitis- a randomised control trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Eswaran Mythilisri |
| Designation |
post graduate |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
Department of Orthopaedics, SRM medical college hospital and research centre, Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
9791125472 |
| Fax |
|
| Email |
em2526@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devi Prasad |
| Designation |
Professor |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
Department of Orthopaedics, SRM medical college hospital and research centre, Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
8778991526 |
| Fax |
|
| Email |
devipras@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devi Prasad |
| Designation |
Professor |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
Department of Orthopaedics, SRM medical college hospital and research centre, Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
8778991526 |
| Fax |
|
| Email |
devipras@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM medical college hospital and research centre, Kattankulathur, Chennai, Tamilnadu, India 603203 |
|
|
Primary Sponsor
|
| Name |
SRM medical college hospital and research centre |
| Address |
Department of Orthopaedics, SRM medical college hospital and research centre, Kattankulathur, Chennai, Tamilnadu, India 603203 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Eswaran Mythilisri |
SRM medical college hospital and research centre |
Department of Orthopaedics, SRM medical college hospital and research centre, Kattankulathur
Chennai
TAMIL NADU |
9791125472
em2526@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Students |
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 |
intralesional injection |
intralesional corticosteroid injection- 2ml of triamcinolone acetonide with 2ml of 5% lignocaine will be given over the medial aspect of calcaneum of the affected foot with plantar fasciitis |
| Comparator Agent |
Physiotherapy |
physiotherapy- therapeutic ultrasound 3 sessions per week for 4 weeks along with stretching exercises for 4 weeks will be given for the affected foot with plantar fasciitis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
patients aged above 18 years, diagnosed with plantar fasciitis and consenting for the trial will be included |
|
| ExclusionCriteria |
| Details |
age below 18 years, unwilling to consent for the trial, previous surgery or trauma of the foot and ankle, arthritis or neurological impairment of the foot and ankle, patients undergone any medical or surgical treatment for plantar fasciitis prior to this study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduced pain level assessed by visual analogue pain scale score |
pre-treatment, 1 month, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assess the foot and ankle ability measure score |
pre-treatment, 1 month, 3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
13/11/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Patients who are diagnosed with plantar fasciitis are included in the study. Their VAS score and FAAM score are calculated and divided into 2 groups. Group A will receive physiotherapy as specified and group B will receive intralesional corticosteroid injection as specified. Following intervention, patients will be followed up at 1 month and 3 months of treatment and their VAS score and FAAM score will be assessed to find out which group has better pain relief. |