| CTRI Number |
CTRI/2023/07/054974 [Registered on: 10/07/2023] Trial Registered Prospectively |
| Last Modified On: |
11/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different types of injectable medications in the treatment of biceps tendinopathy under ultrasound guidance |
|
Scientific Title of Study
|
Effectiveness of Ultrasound Guided Platelet Rich Plasma Injection in Comparison with
Corticosteroid Injection on Improving Pain & Function in the Treatment of Biceps Tendinopathy: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sagolsem Adarsh Singh |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Sports Medicine Regional Institute of Medical Sciences Imphal West 795004
Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
8420224171 |
| Fax |
|
| Email |
Sagolsem59@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akoijam Joy Singh |
| Designation |
Professor and Head |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Sports Medicine
Regional Institute of Medical Sciences Imphal West 795004
Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
9436026960 |
| Fax |
|
| Email |
joyakoijam2@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
AKOIJAM JOY SINGH |
| Designation |
Professor and Head |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Sports Medicine
Regional Institute of Medical Sciences Imphal West 795004
Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
9436026960 |
| Fax |
|
| Email |
joyakoijam2@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Regional Institute of Medical Sciences Imphal West
795004 Manipur |
|
|
Primary Sponsor
|
| Name |
Regional Institute of Medical Sciences |
| Address |
Regional Institute of Medical Sciences Imphal West 795004
Manipur |
| 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 |
| SAGOLSEM ADARSH SINGH |
Regional Institute of Medical Sciences |
Department of Sports Medicine
Regional Institute of Medical Sciences Imphal West
795004
MANIPUR
Imphal West
MANIPUR |
8420224171
SAGOLSEM59@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH ETHICS BOARD, RIMS IMPHAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M678||Other specified disorders of synovium and tendon, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound guided Corticosteroid injection |
Corticosteroid injection solution will be prepared by a combination of 1 ml of triamcinolone acetate (40mg/ml) and 1 ml of 0.5% bupivacaine. The patient will be made to lie comfortably in supine position with the affected arm in neutral rotation. The skin of the anterior shoulder will be prepped and draped in a sterile fashion. The transducer of the ultrasound will be placed longitudinally over the bicipital groove and a 22 gauge spinal needle will be introduced at a 30 degree angle in a distal to proximal direction, with the long axis of the transducer being parallel to the axis of the needle producing an in plane ultrasonographic view of the needle. 2 ml of the corticosteroid solution will then be administered with the distension of the bicipital sheath by the injectate being visible under ultrasound. Needle will then be removed and local homeostasis will be achieved by applying pressure over the injection site |
| Intervention |
Ultrasound guided platelet rich plasma injection |
PRP will be prepared using the double spin method. Whole blood will be drawn in a 20ml syringe by venipuncture which is then transferred to Acid Citrate Dextrose tubes. These tubes are then centrifuged using a soft spin at 2400 rpm for ten minutes. The supernatant plasma containing platelets is then collected in a separate plain vial and then centrifuged again using a hard spin of 3600 rpm for 15 minutes to obtain a platelet concentrate. The lower 1/3rd is platelet rich plasma (PRP) and upper 2/3rd is platelet poor plasma (PPP). 2ml of PRP will then be procured by removing the PPP. The patient will be made to lie comfortably in supine position with the affected arm in neutral rotation. The skin of the anterior shoulder will be prepped and draped in a sterile fashion. The transducer of the ultrasound will be placed longitudinally over the bicipital groove and a 22 gauge spinal needle will be introduced at a 30 degree angle in a distal to proximal direction, with the long axis of the transducer being parallel to the axis of the needle producing an in plane ultrasonographic view of the needle. 2 ml of the freshly prepared PRP will then be administered with the distension of the bicipital sheath by the injectate being visible under ultrasound. Needle will then be removed and local homeostasis will be achieved by applying pressure over the injection site. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinical and Ultrasound diagnosed cases of bicipital tendinosis
2. Age between 18 to 60 years of age
3. Failure of conservative treatment > 3months
4. Willingness to comply with treatment and follow up assessment
|
|
| ExclusionCriteria |
| Details |
1. Local injection within 6 weeks
2. Local infection at the site of injection
3. Evidence of rotator cuff tear, GHJ deformity or rupture of LHB tendon on MRI
4. Uncontrolled systemic disease
5. Thrombocytopenia (<1.5 lakhs/cumm)
6. Bleeding disorder
7. Pregnancy
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Visual analogue scale (VAS)
2. Single Assessment Numeric Evaluation (SANE) score &
3. QuickDASH SCORE |
At the end of 4 weeks 12 weeks & 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| QuickDASH score |
at end of 4, 12 & 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 2 |
|
Date of First Enrollment (India)
|
15/07/2023 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
This is a randomised, parallel group controlled trial comparing platelet rich plasma injection with corticosteroid injection given under ultrasound guidance in the treatment of bicipital tendinopathy in 32 patients that will be conducted in the department of sports medicine, imphal , Manipur. The outcome measures for the study will be Visual analogue scale, SANE score and QuickDASH score measured at 4, 12 and 24 weeks post intervention. |