| CTRI Number |
CTRI/2024/04/066454 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Hospital based interventional comparative study ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An interventional study to compare the effect of steroid injection versus dextrose prolotherapy in management of medial heel pain |
|
Scientific Title of Study
|
An interventional study compararive study to compare the effect of Ultrasound-Guided methylpredinsolone acetate injection versus dextrose prolotherapy in management of plantar fasciitis |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Chuka Kumari |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of PMR Room Number 3 Ground floor RRR Building gate Number 3 SMS Medical College Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
7568928907 |
| Fax |
|
| Email |
drchukachuka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR OMPARKASH |
| Designation |
Guide ASSOCIATE PROFESSOR |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of PMR Room Number 3 Ground Floor RRR Building gate Number 3
SMS Medical Collee Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
7597202012 |
| Fax |
|
| Email |
opurmi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR OMPARKASH |
| Designation |
Guide ASSOCIATE PROFESSOR |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of PMR Room Number 3 RRR Building gate Number 3
SMS Medical Collee Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
7597202012 |
| Fax |
|
| Email |
opurmi@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SMS Medical College Jaipur |
| Address |
Department of PMR RRR Building gate Number 3 SMS Medical College Jaipur pin code 302004 Rajasthan |
| Type of Sponsor |
Government 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 |
| Dr Omprakash |
Sawai mansingh medical college jaipur |
Out patients Room No 3 Ground Floor Department of Physical Medicine and Rehabilitation SMS Medical College and attached Hospitals Jaipur
Jaipur
RAJASTHAN |
7597202012
opurmi@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the ethics committee SMS medical College and attached hospitals Jaipur |
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 |
injection methylprednisolone acetate |
Injection 2ml methyl prednisone acetate ( 80mg) +1ml of 2% lignocaine only one time ( single injection) |
| Comparator Agent |
Dextrose prolotherapy |
2ml of 25% dextrose + 1ml of 2% lidocaine for one time ( Single injection) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients of chronic plantar fasciitis
2. Those giving signed informed consent for study
3. Patients is not a part of any other study
4. Numeric Rating Scale score more than4 Duration of symptoms more than 2 months |
|
| ExclusionCriteria |
| Details |
1.History of any surgery or injection to the plantar fascia/heel in last 6 months.
2.History of trauma, fracture to heel or any other surgeries leading to any functional limitation of the affected foot.
3.Other medical/surgical condition other than PF producing heel symptoms: like peripheral neuropathy, positive tinel’s sign at the medial ankle, ischemia, systemic inflammation and connective tissue disease; history of disc herniation, etc.
4.History of any systemic disorders or bleeding disorders or intake of anticoagulants or other medical conditions where steroid/dextrose injection is contraindicated like uncontrolled diabetes, coagulation disorders, paresthesia or numbness at heel, presence of cyst, mass, or local skin infection at the site of pain.
5.Pregnant or lactating mothers.
6.Any special treatment taken in the past 4 weeks with interfere the outcome assessment, including iontophoresis, phonophoresis, and shockwave therap |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain intensity with Numeric Rating Scale (NRS)
2. Functional outcome measure with
A. The Foot and Ankle Ability Measure (FAAM)
B. Foot Function Index (FFI)
3. Ultrasonographic assessments |
NRS,FAAM,FFI and USG assessments at baseline, 2 weeks and 12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional outcome measure
With
A The Foot & Ankle Ability Measure
B Foot Function Index |
FAAM FFI measure at 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/05/2024 |
| 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="10"
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
|
The purpose of our study is to evaluate and compare the therapeutic effect of ultrasound guided methylprednisolone acetate (MPA)versus dextrose prolotherapy injection in chronic PF. Most of the patients want to avoid steroid injection due to its possible side effects. The purpose of our study is to find a better/alternative, safer injection ( Prolotherapy) for the treatment of chronic plantar fasciitis |