| CTRI Number |
CTRI/2024/12/077578 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| 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
|
Comparison of effect of two different physiotherapy intervention in Athlete with Glenohumeral internal rotation deficit. |
|
Scientific Title of Study
|
Comparison of Modified Sleeper Stretch to Modified Cross Body Stretch as an Adjunct to Muscle Energy Technique in Athlete with Glenohumeral Internal Rotation Deficit. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MD Shahid Raza |
| Designation |
Assistant Professor |
| Affiliation |
Centre For Physio,Jamia Millia Islamia |
| Address |
Room number 106, Centre For Physiotherapy And Rehabilitation Sciences, Jamia Millia Islamia, Jamia Nagar, New Delhi, India
South
DELHI
110025
India |
| Phone |
9212156165 |
| Fax |
|
| Email |
mraza1@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
MD Shahid Raza |
| Designation |
Assistant Professor |
| Affiliation |
Centre For Physio,Jamia Millia Islamia |
| Address |
Room number 106, Centre For Physiotherapy And Rehabilitation Sciences, Jamia Millia Islamia, Jamia Nagar, New Delhi, India
South
DELHI
110025
India |
| Phone |
9212156165 |
| Fax |
|
| Email |
mraza1@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Moin Rashid |
| Designation |
Post Graduate Student |
| Affiliation |
Centre For Physiotherapy And Rehabilitation Sciences,Jamia Millia Islamia |
| Address |
Room number 106, Centre For Physiotherapy And Rehabilitation Sciences, Jamia Millia Islamia, Jamia Nagar, New Delhi, India
South
DELHI
110025
India |
| Phone |
959609965 |
| Fax |
|
| Email |
moinrashid3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia, Jamia Nagar, New Delhi, India- 110025 |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences,, Jamia Nagar, New Delhi, India- 110025 |
| Type of Sponsor |
Other [Central university] |
|
|
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 Md Shahid Raza PT |
Centre for Physiotherapy and Rehabilitation Sciences |
Physiotherapy OPD, Room number 08, Ground Floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi- 110025
South
DELHI |
09212156165
mraza1@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jamia Millia Islamia |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Modified Cross Body Stretch in combination with Muscle Energy Technique. |
Patient in this group will perform Modified Cross Body stretch (MCBS) then Muscle energy technique (MET) will be given five times a week for four weeks. Treatment duration will be 20-30 minutes. The Modified Cross Body Stretch will be performed with the athlete side-lying on their dominant side, with both legs semi-flexed, the elbow bent to 90°, the shoulder elevated to 90°, and the trunk rotated posteriorly by 20° to 30°. The physical therapist will stabilize the participants back to limit excessive trunk rotation. The forearm of the non-dominant side will be placed on top of the dominant side’s forearm, while the participant will grasp the distal end of the dominant humerus with the other hand. This positioning will prevent external rotation of the dominant shoulder by applying counter-pressure with the opposing forearm. Passive horizontal adduction will then perform using the therapist’s opposing hand. The stretch will be maintained for 30 seconds. The protocol will be repeated 3 times. While in Muscle energy technique subject will be positioned supine on the treatment table with the shoulder and elbow, at 90 degree of abduction and flexion. The shoulder will be stabilized at the acromion process with one hand, and the other hand will be used to passively move the arm into internal rotation until the first barrier of motion will reached. The subject will then instructed to perform a 5- second isometric contraction of approximately 25% maximal effort in the direction of external rotation, against an opposing force provided at the distal forearm. Following the contraction, the subject will be instructed to internally rotate the arm toward the ground as a 30-second active assisted stretch will be applied. The subject will instructed to relax, and a new movement barrier will then engaged. This protocol will be performed for a total of 3 repetitions. |
| Comparator Agent |
Modified Sleeper Stretch in combination with Muscle Energy Technique. |
Patient in this group will perform Modified Sleeper Stretch (MSS) then Muscle energy technique (MET) will be given five times a week for four weeks. Treatment duration will be 20-30 minutes. The Modified sleeper stretch Will be performed with the athlete positioned sideways, the shoulder elevated to 90°, and the trunk rotated posteriorly by 20° to 30°. A towel will be placed under the elbow to enhance the stretch at the posterior shoulder while ensuring scapular stability and mitigating the risk of subacromial impingement. Passive internal rotation (IR) will be carried out with the opposing arm in this position. The stretch will be maintained for 30 seconds. The protocol will be repeated 3 times. While in Muscle energy technique subject will be positioned supine on the treatment table with the shoulder and elbow, at 90 degree of abduction and flexion. The shoulder will be stabilized at the acromion process with one hand, and the other hand will be used to passively move the arm into internal rotation until the first barrier of motion will reached. The subject will then instructed to perform a 5- second isometric contraction of approximately 25% maximal effort in the direction of external rotation, against an opposing force provided at the distal forearm. Following the contraction, the subject will be instructed to internally rotate the arm toward the ground as a 30-second active assisted stretch will be applied. The subject will instructed to relax, and a new movement barrier will then engaged. This protocol will be performed for a total of 3 repetitions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Male |
| Details |
1.Overhead athletes involved in cricket, basketball, tennis, volleyball, etc. at university
level.
2.When compared bilaterally, difference in internal rotation ROM of more than 18
degrees and a concomitant loss of total rotational motion of more than 5 degrees
(Manske et al., 2013).
3.Shoulder pain of duration more than 3 months and less than 1 year.
4.NPRS Score from 2 to 6.
5.Participants who have working knowledge of English language, for filling of consent
form.
|
|
| ExclusionCriteria |
| Details |
1.GH dislocation history during the previous year.
2. Deformities of the shoulder and thoracic areas, including kyphotic postures and
scoliosis.
3. Any upper limb surgeries performed within the last 24 months.
4.Taking part in shoulder rehabilitation within the previous 12 months.
5. Movement-limiting neurological and musculoskeletal conditions.
6. Upper limb discomfort both before and after the examinations |
|
|
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 |
1.Glenohumeral internal rotation range of motion.
2.Numeric pain rating scale. |
At Day 0 and at 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional throwing performance. |
At Day 0 and at 4 week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/12/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Athletes will be recruited from Jamia
Millia Islamia’s Sports Complex based on inclusion and exclusion criteria . Subjects will then randomly divided into two groups; Group A and Group B.
Group A will receive MSS in combination with MET, while Group B will receive MCBS in combination with MET. The subjects will be given a
thorough explanation of the goal, the approach, and any potential risks. Prior
to being recruited for the study, each subject will be ask to
provide written and verbal informed consent. Afterward, they will be informed of their rights, potential risks, and the option to
discontinue the study at any time. All data on the permission forms, including
demographic information and pre-intervention assessments, will be kept
private. Data will be collected on day 0 and the 4th week of
intervention which will be the end of the intervention by the treating therapist. Both groups will be analyzed after 4 weeks to assess changes in the dependent variables. The study will be carried out at the Centre for Physiotherapy and Rehabilitation
Sciences, Room number 08, Ground floor, Jamia Millia Islamia, New Delhi, India. |