| CTRI Number |
CTRI/2026/01/102087 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
24/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of FlexiBar Training and Strengthening Exercises on Pain and Hand Strength in Tennis Elbow |
|
Scientific Title of Study
|
Effectiveness of proprioceptive flexibar versus eccentric exercise on pain and grip strength and function in lateral epicondylitis- A randomized clinical 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 |
R KARTHIK MITTU |
| Designation |
Post Graduate |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Musculoskeletal Sciences and sports physiotherapy Department, Institute of
Physiotherapy, Srinivas University, City Campus- Ground floor, Pandeshwar,
Dakshina Kannada, Mangalore
KARNATAKA
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9491717346 |
| Fax |
|
| Email |
rajanollakarthikmittu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRKamalakannan |
| Designation |
HOD Cum Associate Professor, Institute of Physiotherapy, Srinivas University |
| Affiliation |
Institute of Physiotherapy , Srinivas Unuversity |
| Address |
Musculoskeletal Sciences and Sports Physiotherapy Department, Institute of
Physiotherapy, Srinivas University, City Campus- Ground floor, Pandeshwar,
Dakshina Kannada, Mangalore
KARNATAKA 575001
Dakshina Kannada
KARNATAKA
757001
India |
| Phone |
9500931424 |
| Fax |
|
| Email |
kamalakannan.pt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rkarthik Mittu |
| Designation |
Post Graduate |
| Affiliation |
Institute of physiotherapy, Srinivas University |
| Address |
Musculoskeletal sciences and sports physiotherapy department, Institute of
Physiotherapy, Srinivas University, City campus- ground floor, Pandeshwar,
Dakshina Kannada, Mangalore
KARNATAKA 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9491717346 |
| Fax |
|
| Email |
rajanollakarthikmittu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Musculoskeletal Sciences and Sports Physiotherapy Department, Institute of
Physiotherapy, Srinivas University, City Campus- Ground floor, Pandeshwar,
Dakshina Kannada, Mangalore
KARNATAKA 575001 |
|
|
Primary Sponsor
|
| Name |
RKARTHIK MITTU |
| Address |
Musculoskeletal Sciences and Sports Physiotherapy Department, Institute of
Physiotherapy, Srinivas University, City Campus- Ground floor, Pandeshwar,
Dakshina Kannada, Mangalore
KARNATAKA 575001 |
| 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 |
| DrR karthik Mittu |
MUSCULOSKELETAL SCIENCE AND SPORTS PHYSIOTHERAPY DEPARTMENT |
Musculoskeletal Sciences and Sports Physiotherapy Department, Institute of
Physiotherapy, Srinivas University, City Campus- Ground floor, Pandeshwar,
Dakshina Kannada, Mangalore
KARNATAKA 575001
Dakshina Kannada
KARNATAKA |
09491717346
rajanollakarthikmittu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD AND ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M771||Lateral epicondylitis, (2) ICD-10 Condition: M771||Lateral epicondylitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ECCENTRIC EXERCISE |
ECCENTRIC EXERCISE |
| Intervention |
Proprioceptive Flexi-Bar Training |
Proprioceptive Flexi-Bar Training |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Identification of VAS score of 4
Patients suffering from lateral epicondylitis humerus radialis verified by clinical examination with exercise related pain
The diagnosis was confirmed by tenderness upon touch Mills and Cozens tests yielded positive results
|
|
| ExclusionCriteria |
| Details |
Any history of elbow surgery or significant elbow injury in the affected arm
Conditions such as diabetes, rheumatoid arthritis, or other systemic diseases that may affect tendon healing
Co existing injuries such as medial epicondylitis, cubital tunnel syndrome, or shoulder/wrist pathologies
Prior use of corticosteroid injections or physical therapy for the same condition within 4 weeks prior to enrollment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain,
Grip strength |
Base line, 3 weeks, 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Function ( Patient Rated Tennis Elbow Evaluation ) |
Base line, 3 weeks, 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2026 |
| Date of Study Completion (India) |
21/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This randomized clinical trial compares the effectiveness of proprioceptive Flexi-bar exercises and eccentric exercises in reducing pain, improving grip strength, and enhancing function in individuals with lateral epicondylitis. The study involves 56 participants allocated into two groups, with interventions given thrice weekly for six weeks. Outcomes are measured using VAS, hand dynamometer, and PRTEE scores to identify the more effective conservative rehabilitation approach. |