| CTRI Number |
CTRI/2024/03/064901 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Exercises in Upper Cross Syndrome |
|
Scientific Title of Study
|
Effect of Scapular Stabilization
Exercisers and Muscle Energy Technique in Upper Cross Syndrome: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sahil |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy
Guru Jambheshwar University of Science and Technology
Hisar
Hisar
HARYANA
125001
India |
| Phone |
9817656260 |
| Fax |
|
| Email |
gillsahil483@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Boora PT |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy
Guru Jambheshwar University of Science and Technology
Hisar
Hisar
HARYANA
125001
India |
| Phone |
8683810061 |
| Fax |
|
| Email |
mamtaboora50@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Boora PT |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy
Guru Jambheshwar University of Science and Technology
Hisar
Hisar
HARYANA
125001
India |
| Phone |
8683810061 |
| Fax |
|
| Email |
mamtaboora50@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sahil BPT Student Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar |
|
|
Primary Sponsor
|
| Name |
Dr Mamta Boora |
| Address |
Department of Physiotherapy
Guru Jambheshwar University of Science and Technology Hisar |
| Type of Sponsor |
Other [] |
|
|
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 |
| Sahil |
Guru Jambheshwar University of Science and Technology |
Room No.5 OPD Department of Physiotherapy
Hisar
HARYANA |
9817656260
gillsahil483@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of GJUST |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hotpack |
Hotpack will be given to the patients for four weeks. |
| Intervention |
Muscle Energy Technique |
Patients in this group will perform muscle energy technique for three sessions per week for four weeks. |
| Intervention |
Scapular Stabilization Exercises |
Patients in this group will perform scapular stabilization exercises with physioball for three sessions per week for four weeks. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Male |
| Details |
Kyphotic angle more than 40 degree |
|
| ExclusionCriteria |
| Details |
History of recent trauma/injury or recent thoracic injury.
History of any other serious musculoskeletal, neurological, cardiopulmonary and psychological 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 |
Neck range of motion
Pain
Thoracic kyphotic angle |
The outcomes will be assessed for two times which is at the baseline and after the 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Craniovertebral angle |
The outcome will be assessed for two times which is at the baseline and after the 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/04/2024 |
| 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="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 20 patients that will be divided into three groups based on the random method. Its intervention involves scapular stabilization exercises with physio ball and hotpack in the first group, muscle energy technique and hotpack in the second group and hotpack in the control group. The patients will be informed about the study and written informed consent will be taken. Firstly each patients demographic information including age, height and weight will be gathered as a baseline data. Pre-intervention measurements of outcomes variables including Neck ROM, Pain, Craniovertebral angle and Thoracic kyphotic angle will be taken. Post-intervention data of all outcome variables will be taken. |