| CTRI Number |
CTRI/2026/01/100100 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare which treatment option is better in Tennis Elbow patients Platelet Rich Plasma (PRP) injection or Steroid (Triamcinolone acetate) injection |
|
Scientific Title of Study
|
Comparison of Effectiveness of injection Triamcinolone Acetate vs Platelet Rich Plasma (PRP) in management of Lateral Epicondylitis (Tennis Elbow) Patients A Randomized controlled trail |
| 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 Amit Thakur |
| Designation |
Associate Professor |
| Affiliation |
AIIMS JAMMU |
| Address |
Department of Orthopaedics, Unit 1, Room No 232, OPD 2nd Floor, AIIMS Jammu, Vijaypur
Jammu JAMMU & KASHMIR 184120 India |
| Phone |
184120 |
| Fax |
|
| Email |
Amit.thakur@aiimsjammu.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Amit Thakur |
| Designation |
Associate Professor |
| Affiliation |
AIIMS JAMMU |
| Address |
Department of Orthopaedics, Unit 1, Room No 232, OPD 2nd Floor, AIIMS Jammu, Vijaypur
Jammu JAMMU & KASHMIR 184120 India |
| Phone |
184120 |
| Fax |
|
| Email |
Amit.thakur@aiimsjammu.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Amit Thakur |
| Designation |
Associate Professor |
| Affiliation |
AIIMS JAMMU |
| Address |
Department of Orthopaedics, Unit 1, Room No 232, OPD 2nd Floor, AIIMS Jammu, Vijaypur
Jammu JAMMU & KASHMIR 184120 India |
| Phone |
184120 |
| Fax |
|
| Email |
Amit.thakur@aiimsjammu.edu.in |
|
|
Source of Monetary or Material Support
|
| AIIMS Jammu, Vijaypur - 184120, India |
|
|
Primary Sponsor
|
| Name |
AIIMS JAMMU |
| Address |
AIIMS Jammu, Vijaypur - 184120, India |
| 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 Roobal Ramdass |
AIIMS JAMMU |
Department of Orthopaedics, Unit 1, Room No 232, OPD 2nd Floor, AIIMS Jammu, Vijaypur Jammu JAMMU & KASHMIR |
7888932288
roobal.ramdass@aiimsjammu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS Jammu |
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 |
Injection Platelet rich plasma |
1ml at most tender point inside the tendon
Duration for 9 months |
| Intervention |
Injection Triamcinolone Acetate
|
40mg at most tender point around ECRB tendon
Duration for 9 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants were included if they met the following criteria:
1. Diagnosis of chronic lateral epicondylitis of the elbow based on clinical examination. This was defined by: a. Pain on palpation of the lateral epicondyle, and b. Pain during resisted wrist extension or supination of the forearm.
2. Symptoms lasting at least 6 months.3. Failure of conservative treatment, including physiotherapy, nonsteroidal anti-inflammatory drugs (NSAIDs), and rest.
4. Age between 18 and 60 years. 5. No previous injections at the affected elbow. 6. Patient consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Participants were excluded if they presented with any of the following:
1. Bilateral elbow symptoms. 2. Involvement of the cervical spine or shoulder (which could refer pain to the elbow).
3. Rheumatoid arthritis or other inflammatory arthropathy. 4. Coagulopathy (blood clotting disorder). 5. Prior surgery on the affected elbow. 6. Chronic use of corticosteroids. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain intensity: VAS score (0-10) |
At Baseline, 1,3,6 months followup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional Disability: PRTEE (0-100)
Adverse events: incidence and severity recorded at each follow up |
At Baseline, 1,3,6 months followup |
|
|
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)
|
10/01/2026 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Current management of Lateral Epicondylitis (LE) ranges from conservative methods (rest, bracing, physiotherapy, NSAIDs) to injections and surgery. Corticosteroids, like Triamcinolone acetate, are common for rapid short-term pain relief due to their potent anti-inflammatory properties. However, recent randomized controlled trials show that while PRP provides sustained benefits over 3-24 months, corticosteroid effects often diminish. Despite this, a definitive consensus on the comparative efficacy in Lateral Epicondylitis remains inconclusive. Therefore, a well-designed, adequately powered, randomized controlled trial is needed to directly compare Triamcinolone acetate and PRP in chronic Lateral Epicondylitis patients. This study aims to: • Clarify comparative efficacy • Inform clinical decision-making: Provide evidence-based guidance for Lateral Epicondylitis treatment. • Assess safety profiles: Compare adverse events of both injection types. Ultimately, this research will significantly strengthen the evidence base for Lateral Epicondylitis management, improving patient care and optimizing treatment strategies for this common condition. |