| CTRI Number |
CTRI/2024/05/066928 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
04/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to find effectiveness of dextrose injection in comparison of steroid injection in tennis elbow patients. |
|
Scientific Title of Study
|
A prospective international study to determine effectiveness of dextrose prolotherapy injection versus methyl prednisolone acetate injection in patients with Chronic Lateral Epicondylytis |
| 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 Vishnu Bhardwaj |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of PMR
RRC Building
Gate Number 3
SMS Medical College
Jaipur
RAJASTHAN
302004
India |
| Phone |
7798083500 |
| Fax |
|
| Email |
tinkubhardwaj007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Kumar Meena |
| Designation |
Associate Professor |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of PMR
RRC Building
Gate Number 3
SMS Medical College
Jaipur
RAJASTHAN
302004
India |
| Phone |
9828373677 |
| Fax |
|
| Email |
maheshbagdi1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Kumar Meena |
| Designation |
Associate Professor |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of PMR
RRC Building
Gate Number 3
SMS Medical College
Jaipur
RAJASTHAN
302004
India |
| Phone |
9828373677 |
| Fax |
|
| Email |
maheshbagdi1970@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMS Medical College, Jaipur
Rajasthan
India
pin- 302004 |
|
|
Primary Sponsor
|
| Name |
SMS Medical College Jaipur |
| Address |
Department of PMR
RRC Building
Gate Number 3
SMS Medical College Jaipur
Rajasthan
India
pin 302004 |
| 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 mahesh kumar meena |
SMS Medical College Jaipur |
Department of PMR
RRC Building
Gate Number 3
SMS Medical College
Jaipur
RAJASTHAN |
09828373677
MAHESHBAGDI1970@GMAIL.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: M771||Lateral epicondylitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dextrose Injection |
Dextrose Prolotherapy Injection
16% 2ml Dextrose mixed with 1ml Lignocaine 2%
Injected only once in common extensor origin or maximum tender point
Review after 1 and 3 months |
| Intervention |
Steroid Injection |
Injection methyl prednisolone acetate 80 mg/2ml mixed with 1ml Lignocaine 2%
Injected only once in common extensor origin or maximum tender point
Review after 1 and 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Those who willing to give informed written consent for participating in the study
2. Adult patients of aged 18-55 years group.
3. Who are diagnosed with chronic lateral epicondylitis syndrome i.e., lasting more than three months. Diagnosis was made clinically.
|
|
| ExclusionCriteria |
| Details |
1. Who doesn’t give consent for participation
2. Any history of local trauma, surgery, or prior injection about the lateral epicondyle during the last 3 months.
3. The presence of any concomitant cervical radiculopathy in the same limb.
4. Systemic comorbidities such as diabetes, rheumatologic disorders etc.
5. Those with a history of allergy to any component of the injectate or with any medical or surgical condition which interferes with the injection technique.
 
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
VAS SCORE
Q-DASH SCORE |
VAS SCORE
Q-DASH SCORE
AT 0, 1, AND 3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Better drug treatment |
At 0, 1, and 3 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
19/05/2024 |
| Date of Study Completion (India) |
23/06/2025 |
| Date of First Enrollment (Global) |
19/05/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
To Compare the Effectiveness of Injection Methyl Prednisolone Acetate with Injection Dextrose Prolotherapy in Patients with Chronic Lateral Epicondylitis |