| CTRI Number |
CTRI/2025/03/082017 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Exercises for Elbow Pain |
|
Scientific Title of Study
|
Comparative Effect of Mulligan Technique and Theraband Flexbar in patients with Tennis Elbow |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankur kumar |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of
Science and Technology Hisar Haryana 125001
Hisar HARYANA 125001 India |
| Phone |
8340774149 |
| Fax |
|
| Email |
ankursingh9400@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jyoti |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of
Science and Technology Hisar Haryana 125001
Hisar HARYANA 125001 India |
| Phone |
9416665373 |
| Fax |
|
| Email |
jyotisabharwal35@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jyoti |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of
Science and Technology Hisar Haryana 125001
Hisar HARYANA 125001 India |
| Phone |
9416665373 |
| Fax |
|
| Email |
jyotisabharwal35@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ankur Kumar MPT Student Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana India 125001 |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy |
| Address |
Guru Jambheshwar University of Science and Technology Hisar
Haryana 125001 India |
| Type of Sponsor |
Research institution |
|
|
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 Jyoti |
Guru Jambheshwar University of Science and Technology |
Room No 05 Department of Physiotherapy OPD GJUS&T
Hisar Haryana 125001
HARYANA Hisar HARYANA |
9416665373
jyotisabharwal35@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of GJUS&T |
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 |
| Intervention |
Mulligan Technique, Hot Pack and Ultrasound |
Patients in this group will
perform Mulligan Technique, Hot Pack and Ultrasound for three sessions per week for four weeks |
| Comparator Agent |
Theraband Flexbar Exercises, Hot Pack and Ultrasound |
Patients in this group will perform Theraband Flexbar Exercises, Hot Pack and Ultrasound for three sessions per week for four weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age between 20 to 70 years
Duration of symptoms of Tennis Elbow is less than 10days
Mills and cozen test positive
VAS score more than 3 |
|
| ExclusionCriteria |
| Details |
Acute trauma
Elbow fractures
Elbow subluxation or dislocation
Upper limb neurological abnormalities
Recent steroid injection less than 6 weeks
Metastatic lesion
Arthritis
Intake of psychotherapeutic drugs
Cervical spine disorders |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual analog scale
Disability of Arm, Shoulder and Hand
Patient related Tennis Elbow evaluation
|
The outcome will be assessed for two times
which is at the baseline and after the 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range of Motion |
The outcome will be assessed for two times
which is at the baseline and after the 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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 1 |
|
Date of First Enrollment (India)
|
28/03/2025 |
| 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="0" Months="0" Days="28" |
|
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
|
It is a randomized controlled trial with a duration of 4 weeks and involving 80 patients that will be divided into two groups based on the lottery method. Its intervention involves mulligan technique, hot pack and ultrasound in one group and theraband flexbar, hot pack and ultrasound in second group. The patients will be informed about the study and written informed consent will be taken. First, each patient’s demographic information including age, height and weight will be gathered as a baseline data. Pre- Intervention measurements of outcome variables including VAS, DASH, PRTEE, Range of motion will be taken. Intervention will be given for 4 weeks and then post-intervention data of all the outcome variables will be taken. |