| CTRI Number |
CTRI/2022/09/045515 [Registered on: 14/09/2022] Trial Registered Prospectively |
| Last Modified On: |
04/02/2023 |
| 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
|
Comparison of two manual therapy techniques for shoulder pathology among athletes |
|
Scientific Title of Study
|
A COMPARATIVE STUDY ON THE EFFECTIVENESS OF
MUSCLE ENERGY TECHNIQUE AND ACTIVE RELEASE
TECHNIQUE ON THE GLENOHUMERAL INTERNAL ROTATION
DEFICIT (GIRD) IN YOUNG THROWING ATHLETES |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Debasis Behera |
| Designation |
PG scholar |
| Affiliation |
Alvas college of physiotherapy |
| Address |
Alvas college of physiotherapy
Moodbidri
Dakshina Kannada
Alvas college of physiotherapy
Moodbidri
Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
08018927933 |
| Fax |
|
| Email |
beheradepasis1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sneha Vishwanath |
| Designation |
Assistant professor |
| Affiliation |
Alvas college of physiotherapy |
| Address |
Alvas college of physiotherapy
Moodbidri
Dakshina Kannada
Alvas college of physiotherapy
Moodbidri
Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9739314175 |
| Fax |
|
| Email |
snehapt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Debasis Behera |
| Designation |
PG scholar |
| Affiliation |
Alvas college of physiotherapy |
| Address |
Alvas college of physiotherapy
Moodbidri
Dakshina Kannada
Alvas college of physiotherapy
Moodbidri
Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
08018927933 |
| Fax |
|
| Email |
beheradepasis1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas college of physiotherapy
Moodbidri
Dakshina Kannada
Department of orthopaedic, infrastructure support couch, chair |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Debasis Behera |
Alvas college of physiotherapy |
Alvas college of physiotherapy
Moodbidri
Dakshina Kannada
Department of physiotherapy Room no.2
Dakshina Kannada
KARNATAKA |
8018927933
beheradepasis1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Alvas college of physiotherapy ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Glenohumeral internal rotation deficit |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active release technique |
ART for 5 repetitions 10 seconds hold followed by stretching for 30 seconds and mobilization 10 repetitions for 3 sets total duration of intervention will be 5-10 minutes intervention will be given 3 alternative days of a week for four weeks |
| Intervention |
Conventional therapy |
Mobilization for 3 session 10 repetitions followed by stretching for 30 seconds total duration of intervention will be 5-10 minutes
Intervention will be given 3 alternative days of a week for four weeks |
| Comparator Agent |
MET ART and conventional therapy |
Comparison between three groups after 4 weeks of intervention |
| Intervention |
Muscle energy technique |
MET for 3 repetitions 5 seconds each followed by stretching for 30 seconds and mobilization 10 repetitions for 3 sets total duration of intervention will be 5-10 minutes intervention will be given 3 alternative days in a week for four weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Male |
| Details |
Glenohumeral internal rotation deficit more than 15 degree
Overhead throwing athletes |
|
| ExclusionCriteria |
| Details |
Post-surgical case
Dominant shoulder instability
Dominant shoulder injury |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Range of motion
Shoulder pain and disability index |
It will be evaluated after four weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="57"
Sample Size from India="57"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/09/2022 |
| Date of Study Completion (India) |
01/02/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study was conducted to find out the effects of muscle energy technique and active release technique on overhead throwing athletes between 18-25 years of age who are participating in cricket, volleyball and badminton having glenohumeral internal rotation deficit. Total 87 athletes were screened out of which 42 athletes eligible for the study on the basis of inclusion and exclusion criteria. Baseline outcome measure SPADI and ROM taken and participants were divided into three groups. Group A received MET and conventional therapy. Group B received ART and conventional therapy. Group C received conventional therapy only. After 4 weeks of intervention post assessment were taken. Data was analysed by using SPSS software. Results of the study showed that the Muscle energy technique is more effective than active release technique in improving shoulder internal rotation ROM, but both the technique has equally effective in improving shoulder function among athletes with GIRD. |