| CTRI Number |
CTRI/2022/08/044590 [Registered on: 03/08/2022] Trial Registered Prospectively |
| Last Modified On: |
02/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of McKenzie and theraband (stretching and strengthening) exercises in the treatment of upper cross syndrome |
|
Scientific Title of Study
|
Efficacy of various exercises in the management of upper cross syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Charu Gera |
| Designation |
Assistant professor |
| Affiliation |
GURU JAMBHESHWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY,HISAR HARYANA, |
| Address |
DEPARTMENT OF PHYSIOTHERAPY, GURU JAMBHESHWAR
UNIVERSITY OF SCIENCE AND TECHNOLOGY,HISAR
Hisar
HARYANA
125001
India |
| Phone |
9467940405 |
| Fax |
|
| Email |
Charugera321@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Gera |
| Designation |
Assistant professor |
| Affiliation |
GURU JAMBHESHWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY,HISAR HARYANA, |
| Address |
DEPARTMENT OF PHYSIOTHERAPY, GURU JAMBHESHWAR
UNIVERSITY OF SCIENCE AND TECHNOLOGY,HISAR
Hisar
HARYANA
125001
India |
| Phone |
9467940405 |
| Fax |
|
| Email |
Charugera321@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sonu |
| Designation |
BPT Student |
| Affiliation |
GURU JAMBHESHWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY,HISAR Haryana |
| Address |
DEPARTMENT OF PHYSIOTHERAPY, GURU JAMBHESHWAR
UNIVERSITY OF SCIENCE AND TECHNOLOGY,HISAR
Haryana
Hisar
HARYANA
125001
India |
| Phone |
9034278389 |
| Fax |
|
| Email |
Lambasonu768@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self (Sonu) BPT student, DEPARTMENT OF PHYSIOTHERAPY GURU JAMBHESHWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF PHYSIOTHERAPY |
| Address |
DEPARTMENT OF PHYSIOTHERAPY GURU JAMBHESHWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY |
| Type of Sponsor |
Other [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 |
| Sonu |
GURU JAMBHESHWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY, HISAR |
Room no 5
Ground floor, OPD
Department of Physiotherapy
Guru Jambheshwar University of Science and Technology, Hisar, Haryana
Hisar
HARYANA |
9034278389
Lambasonu768@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
McKenzie exercises |
McKenzie exercises will be performed 5days per week for a period of 3 weeks. The patients will also be asked to perform simple shoulder exercises. Follow up will also be done after 2 more weeks. |
| Comparator Agent |
Nil |
Not applicable |
| Intervention |
Theraband exercises |
Theraband exercises will be performed 5 days per week for a period of 3 weeks to strengthen the weak muscles. Follow up will also be done after 3 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 20-40 yrs.
2. Both male and female.
3. Group of muscles undergone weakness and
tightness
4. CVA less than 50 degree.
|
|
| ExclusionCriteria |
| Details |
1. Patients who are undergoing some other
treatment.
2. Any history of trauma or surgery due to
musculoskeletal diseases which interfered
with the position.
3. Fracture or joint diseases of spine
4. Children |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain (shoulder pain and disability index (SPADI)
Posture |
Baseline evaluation after 3 weeks (at the time of intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Strength (Manual muscle testing)
|
Baseline, after 3 weeks(at the end of intervention) |
|
|
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)
|
04/08/2022 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Upper cross syndrome is characterized by certain postural alterations, such as forward head position, a rise in cervical and thoracic kyphosis, elevated and protracted shoulders, rotation or abduction of scapula, and winging of scapula. Due to the weakening of the serratus anterior, which causes the glenoid fossa to become more vertical and causes the scapulae to rotate, abduct, and wing, these postural alterations reduce the stability of the glenohumeral joint.This study contains two groups one group with McKenzie exercises and the 2nd group perform various theraband exercises for the management of UCS. |