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CTRI Number  CTRI/2025/10/096247 [Registered on: 21/10/2025] Trial Registered Prospectively
Last Modified On: 19/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing two steroid injections to compare which gives longer pain relief in patients with tennis elbow 
Scientific Title of Study   Comparative Efficacy of Triamcinolone Acetonide 40mg and Triamcinolone Hexacetonide 20mg for Symptom-free Interval in Lateral Epicondylitis: A Double blind, Randomized controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  aeliya fatima 
Designation  Junior resident 
Affiliation  ESIC Medical College and Hospital 
Address  Department of phamacology, 4th floor academic block, esic medical college and hospital National Highway 65 Sanjeeva Reddy Nagar, Sanath Nagar, Hyderabad, Telangana 500038

Hyderabad
TELANGANA
500038
India 
Phone  9701224239  
Fax    
Email  draeliyafatima67@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S seethalakshmi 
Designation  Professor and HOD 
Affiliation  ESIC Medical College and Hospital 
Address  Department of pharmacology, 4th floor academic block, ESIC medical college and hospital National Highway 65 Sanjeeva Reddy Nagar, Sanath Nagar, Hyderabad, Telangana 500038

Hyderabad
TELANGANA
500038
India 
Phone  6369702539  
Fax    
Email  seethapharmacology@gmail.com  
 
Details of Contact Person
Public Query  
Name  aeliya fatima 
Designation  Junior resident 
Affiliation  ESIC Medical College and Hospital 
Address  Department of pharmacology, 4th floor academic block, Esic medical college and hospital National Highway 65 Sanjeeva Reddy Nagar, Sanath Nagar, Hyderabad, Telangana 500038

Hyderabad
TELANGANA
500038
India 
Phone  9701224239  
Fax    
Email  draeliyafatima67@gmail.com  
 
Source of Monetary or Material Support  
Department of pharmacology, 4th floor academic block, ESIC medical college and hospital National Highway 65 Sanjeeva Reddy Nagar, Sanath Nagar, Hyderabad, Telangana 500038 
 
Primary Sponsor  
Name  AELIYA FATIMA 
Address  Department of pharmacology, 4th floor academic block, ESIC medical college and hospital National Highway 65 Sanjeeva Reddy Nagar, Sanath Nagar, Hyderabad, Telangana 500038 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aeliya Fatima  Esic Medical college and hospital  Department of pharmacology, 4th floor academic block, ESIC medical college and hospital National Highway 65 Sanjeeva Reddy Nagar, Sanath Nagar, Hyderabad, Telangana 500038
Hyderabad
TELANGANA 		 09701224239

draeliyafatima67@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Triamcinolone acetonide  40mg of Triamcinolone acetonide given intralesionally in Lateral epicondylitis. Given as a one time injection on visit 1 after screening and informed consent. Patient will then be followed up for 6 months after injection is given 
Intervention  Triamcinolone hexacetonide  20mg of Triamcinolone hexacetonide given intralesionally in Lateral epicondylitis. Injection will be given as a one time dose on Visit 1 after screening and informed consent after which the patient will be followed up for 6 months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Tenderness on palpation of lateal epicondyle and extensor unit
2. Pain at the effected site on gripping hand dynamometer at any pressure
3.Pain on contraction of wrist extensors using cozens test.
4. Symptoms of greater then 6 weeks duration 
 
ExclusionCriteria 
Details  1. History of surgery or trauma to the effected elbow.
2. History of corticosteroid injection in past 6 months.
3. Co-existing systemic conditions like rheumatoid arthritis and other Auto-immune diseases, Uncontrolled diabetes mellitus.
4. Ongoing local or systemic infection.
5. Pregnant or lactating women.
6. History of psychiatric diseases.
7. Any previous drug reaction to corticosteroids.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
PRIMARY OUTCOME
1. To assess the return or increase in pain on follow up
2. To asses level of pain using VAS
3. To assess level of pain using PRTEE Questionnaire
 		 VISIT 1( WEEK -1)
VISIT 2( WEEK 1)
VISIT 3(WEEK 12)
VISIT 4(WEEK 24)
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Grip strength using hand dynamometer measured at visit 2,3 and 4
2. Compare the incidence of adverse effects at visit 3 and 4
 		 VISIT 1( WEEK -1)
VISIT 2( WEEK 1)
VISIT 3(WEEK 12)
VISIT 4(WEEK 24)
 
 
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   Phase 4 
Date of First Enrollment (India)   01/11/2025 
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)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Lateral epicondylitis, one of the most common clinically diagnoses elbow disorders is a self limiting condition with a long disease duration. Which is why intervention is commonly given which includes both pharmacological and non pharmacological methods one of which is a steroid injection. Most commonly used steroid is Triamcinolone acetonide which is being compared to Triamcinolone Hexacetonide in this study. Reasen for the use of Triamcinolone Hexacetonide is thta is it more lipophilic and has a lower aqueous solubility so leads to slower absorption from the injection site.
The primay objective of this study is to confirm the duration of symptom free period after initial pain relief. The secondary objective is to assess the hand strength and adverse effects between the two treatment groups.
Study will be conducted by the department of phamacology in collaboration with the department of Physical medicine and rehabilitation. It is a prospective, randomized, Double blind, Parallel, Two-armed controlled study.
Sample size used is 84 patients with lateral epicondylitis for a study duration of 6 months each.
   Inclusion Criteria:
1.     Patients of either gender aged between 18 to 60 years.
2.     Tenderness on palpation of Lateral epicondyle and the extensor unit.
3.     Pain at the effected site on gripping hand dynamometer at any pressure.
4.     Pain on contraction of wrist extensors using Cozen test.
5.     Symptoms of >= 6 weeks duration.
Exclusion Criteria:
1.     History of surgery or trauma to the effected elbow.
2.     History of corticosteroid injection in past 6 months.
3.     Co-existing systemic conditions like rheumatoid arthritis and other Auto-immune diseases, Uncontrolled diabetes mellitus.
4.     Ongoing local or systemic infection.
5.     Pregnant or lactating women.
6.     History of psychiatric diseases.
7.     Any previous drug reaction to corticosteroids.
There will be 4 visits where screeign and informed consent will be taken on Visit 1, intervantion will be given on visit 2 and the VAS, PRTEE and dynamometre reading will be taken on Visit 2,3 and 4.

 
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