CTRI Number |
CTRI/2018/02/011764 [Registered on: 07/02/2018] Trial Registered Retrospectively |
Last Modified On: |
08/06/2017 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
comparison between 3 steroid injections for treating heel pain |
Scientific Title of Study
|
comparative study of local injections of Methyl prednisolone, triamcinolone and dexamethasone in management of plantar fascitis |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr shaikh Huzaif Badiuddin |
Designation |
Resident in pharmacology |
Affiliation |
MGMs medical college, Aurangabad |
Address |
Department of pharmacology, MGM Medical College, N-6 cidco, Aurangabad.
Aurangabad MAHARASHTRA 431001 India |
Phone |
|
Fax |
|
Email |
huzaifshaikh001@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr shaikh Huzaif Badiuddin |
Designation |
Resident in pharmacology |
Affiliation |
MGMs medical college, Aurangabad |
Address |
Department of pharmacology,MGMs medical college, Aurangabad.
Aurangabad MAHARASHTRA 431001 India |
Phone |
9156495919 |
Fax |
|
Email |
huzaifshaikh001@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr shaikh Huzaif Badiuddin |
Designation |
Resident in pharmacology |
Affiliation |
MGMs medical college, Aurangabad |
Address |
Department of pharmacology,MGMs medical college, Aurangabad
Aurangabad MAHARASHTRA 431001 India |
Phone |
9156495919 |
Fax |
|
Email |
huzaifshaikh001@gmail.com |
|
Source of Monetary or Material Support
|
MGMs medical college, Aurangabad |
|
Primary Sponsor
|
Name |
no |
Address |
no |
Type of Sponsor |
Other [no] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Deepak bhosle |
Department of orthopaedics |
MGM medical college N6 Cidco Aurangabad Aurangabad MAHARASHTRA |
9049484204
drdeepakbhosle@gmail.com |
Dr shaikh huzaif badiuddin |
Department of Pharmacology |
4th floor
MGM medical college
N6 cidco
Aurangabad Aurangabad MAHARASHTRA |
9156495919
huzaifshaikh001@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
MGM-ECRHS |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Plantar fascitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Injection dexamethasone |
Injection dexamethasone which is glucocorticoid will be given stat locally in the heel of patients of group C |
Intervention |
injection methyl prednisolone |
injection methyl prednisolone which is a glucocorticoid will be given stat locally in the heel to patients of group A |
Comparator Agent |
Injection triamcinolone |
Injection triamcinolone which is a glucocorticoid will be given stat locally in heel to patients of group B |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1.Patient willing to participate in the study and give consent.
2.Age group of 18-65 years of either sex.
3.Diagnosed cases of plantar fasciitis having symptoms for > 6 weeks.
4.Patients who had a fair trial of other conservative treatment but got no relief.
5.Patients who have not taken the study injectables previously.
|
|
ExclusionCriteria |
Details |
1.Pregnant and lactating women.
2.Patients who are immunocompromised.
3.Patients with history of diabetes, hypertension and tuberculosis.
4.Patient having history of infection in last 3 months
5.Patients with history of psychiatric disorders.
6.Patient with history of peptic ulcer
7.Patients with history of osteoporosis.
8.Patients with history of trauma to heel.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
reduction in pain |
At the end of 2 and 4 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
reduction in discomfort |
At the end of 2 and 4 weeks |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 4 |
Date of First Enrollment (India)
|
01/03/2017 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
no |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
A prospective, randomized, three armed, comparative and open label study will be conducted. Study will be conducted as per ICH-GCP guidelines. Patients presenting with heel pain will be screened and clinical examination will be performed by the orthopaedic surgeons in the orthopaedic OPD. Clinically diagnosed cases of plantar fasciitis would then be subjected to investigations like X-ray, ultrasonography of heel, complete blood count, fasting and post meal sugar and serum uric acid levels for confirming the diagnosis and for finding the pathology. Patients fulfilling the inclusion criteria would be enrolled in the study. Written informed consent in patients own language will be obtained. Three groups of 20 patients each will be made. Randomization will be done using chit method. Group A patients would be given injection Methyl prednisolone 40 mg stat in heel, Group B patients would be given injection Triamcinolone 40 mg stat in heel and Group C patients would be given injection Dexamethasone 4 mg stat in heel. All injections will be given by orthopaedic surgeons in procedure room under all aseptic precautions. Pain intensity will be assessed at start, at 2 weeks and at 4 weeks of starting the treatment using: · Visual analogue scale (VAS) |