| CTRI Number |
CTRI/2023/04/051912 [Registered on: 24/04/2023] Trial Registered Prospectively |
| Last Modified On: |
02/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of Muscle Energy Technique on pectoralis minor tightness |
Scientific Title of Study
Modification(s)
|
Prompt impact of Muscle Energy Technique on tightness of pectoralis muscle in computer users |
| Trial Acronym |
Muscle energy technique on pectoralis minor tightness in computer users |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Upneet Kaur |
| Designation |
MPT Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitation, Maharishi Markandeshwar Deemed to be University,
Mullana
Ambala
Ambala
HARYANA
133207
India |
| Phone |
9988956162 |
| Fax |
|
| Email |
mskaur2323@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunita Sharma |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitation, Maharishi Markandeshwar Deemed to be University,
Mullana
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Sunita Sharma |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitation, Maharishi Markandeshwar Deemed to be University,
Mullana
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Musculoskeletal Physiotherapy Research Lab, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University |
|
|
Primary Sponsor
|
| Name |
Upneet Kaur |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sunita Sharma |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Upneet Kaur |
Maharishi Markandeshwar Hospital Department of Musculoskeletal Physiotherapy |
Department of Musculoskeletal Physiotherapy, OPD
Ambala
HARYANA |
9988956162
mskaur2323@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communiucation of Decision Of Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
pectoralis minor muscle tightness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
(MET) Muscle Energy Technique |
Resisted isometrics is performed for 7 seconds, followed by stretching the muscle for 15 seconds; 3 reps per session in
total 1 session. We will take outcomes measures immediate after giving the intervention |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age 20 to 40 years
Both males and females
Computer users (4-6 hours per day)
Shoulder Pain
Occupation (administrative job, book keeper and cashiers, commercial occupation, policy makers and non-specific occupation)
Pectoralis minor length test (>2.6cm) |
|
| ExclusionCriteria |
| Details |
Cervical Rib
Breast Cancer
Pregnancy
History of shoulder Surgery and Pathology
Clavicular Fracture
Neurogenic And Cardiac Symptoms |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pectoralis Minor Muscle Length |
Before intervention pectoralis minor length is measured and after intervention on the same day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Forward Head Posture |
Before and after intervention on the same day |
| Rounded Shoulder Posture |
Before and after intervention on the same day |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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 3 |
|
Date of First Enrollment (India)
|
30/04/2023 |
| 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="3"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ethical approval of this study will be taken from the student project committee and ethical committee of Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation. Study will be done in accordance with Helsinki declaration revised 2013 and the National Ethical Guidelines for Biomedical Research involving Human Participants, 2017. Recruitment and Intervention:
The objective of the study to see the effect of Muscle Energy Technique (MET) on pectoralis Minor Tightness in computer users, 65 participants aged 20 to 40 will be recruited from MMIPR based on inclusion/exclusion criteria. Pre intervention assessment will be taken by using Pectoralis Minor Muscle Length, Forward Head Posture and Rounded Shoulder Posture as the outcome measures, 2 times in a session every outcome measure before and after intervention. MET of Pectoralis minor will be done by therapist. |