| CTRI Number |
CTRI/2019/10/021802 [Registered on: 25/10/2019] Trial Registered Prospectively |
| Last Modified On: |
19/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
ROLE OF 25% DEXTROSE PROLOTHERAPY VERSUS EXTRA CORPOREAL SHOCKWAVE therapy in the treatment of chronic lateral epicondylitis |
|
Scientific Title of Study
|
Comparison between prolotherapy using 25% dextrose and extracorporeal shock wave therapy in the management of pain and improving functional outcome in patients suffering from chronic lateral epicondylitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEBASISH DEB |
| Designation |
PGT pmr |
| Affiliation |
REGIONAL INSTITUTE OF MEDICAL SCIENCES MANIPUR |
| Address |
RIMS PMR DEPARTMENT IMPHAL WEST
Imphal West
MANIPUR
795004
India |
| Phone |
8794019638 |
| Fax |
|
| Email |
debasishdebpmr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N BIMOL |
| Designation |
Assistant professor |
| Affiliation |
REGIONAL INSTITUTE OF MEDICAL SCIENCES MANIPUR |
| Address |
RIMS PMR DEPARTMENT IMPHAL WEST PIN 795004
Imphal West
MANIPUR
795004
India |
| Phone |
9436070652 |
| Fax |
|
| Email |
bimoldr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DEBASISH DEB |
| Designation |
PGT pmr |
| Affiliation |
REGIONAL INSTITUTE OF MEDICAL SCIENCES MANIPUR |
| Address |
RIMS PMR DEPARTMENT IMPHAL WEST
Imphal West
MANIPUR
795004
India |
| Phone |
8794019638 |
| Fax |
|
| Email |
debasishdebpmr@gmail.com |
|
|
Source of Monetary or Material Support
|
| REGIONAL INSTITUTE OF MEDICAL SCIENCES IMPHAL WEST |
|
|
Primary Sponsor
|
| Name |
DEBASISH DEB |
| Address |
RIMS PMR DEPARTMENT IMPHAL WEST PIN-795004 |
| 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 |
| DEBASISH DEB |
REGIONAL INSTITUTE OF MEDICAL SCIENCES |
RIMS PMR DEPARTMENT ROOM NUMBER 15 IMPHAL WEST PIN-795004
Imphal West
MANIPUR |
8794019638
debasishdebpmr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH ETHICS BOARD RIMS |
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 |
ESWT |
ESWT in tender lateral epicondyle once a week for 3 weeks in patients suffering from chronic lateral epicondylitis |
| Intervention |
prolotherapy |
prolotherapy using 25% dextrose(2ml) at tender lateral epicondyle in patients suffering from chronic lateral epicondylitis |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Duration of symptoms for at least 6 months
Failed conservative treatment
Willingness to comply with treatment and
follow-up assessment
|
|
| ExclusionCriteria |
| Details |
Duration of symptoms less than 6 months
History of previous surgery in the same tendon
Implanted hardware adjacent to the target treatment region
Abnormal radiographic findings like Osteophtyes, Calcification, or Exostosis
pregnancy
Diabetes
Cancer
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
improvement in pain in terms of VAS
improvement in functional outcome in terms of Grip strength |
BASELINE, 1MONTH, 3MONTH, 6MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| grip srtength assessment |
at baseline, 1month,3 month, 6month |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
05/11/2019 |
| 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="1"
Months="6"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This a randomized controlled trial comparing between 25% dextrose prolotherapy and extra-corporeal shock wave therapy in the management of pain and improving functional outcome in patients suffering from chronic lateral epicondylitis, sample size is 84,block randomisation is used, VAS and Grip strength assessment has been taken as primary outcome measures |