| CTRI Number |
CTRI/2023/10/059361 [Registered on: 31/10/2023] Trial Registered Prospectively |
| Last Modified On: |
02/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Global Postural Re-education and Egoscue exercise in upper cross syndrome on neck pain, forward head and rounded shoulder posture |
|
Scientific Title of Study
|
Global Postural Re-education versus Egoscue exercise in Upper Cross Syndrome on neck pain, forward head and rounded shoulder posture - A Randomised clinical 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 |
Vaishnavi Aghav |
| Designation |
PG student |
| Affiliation |
KAHER Institute of physiotherapy |
| Address |
Advanced physiotherapy center, room no. 39, sagar floor, KLE Dr Prabhakar Kore Hospital Belgaum Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9156948349 |
| Fax |
|
| Email |
vaishnaviaghav1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Peeyoosha Gurudut |
| Designation |
Professor |
| Affiliation |
KLE Institute of physiotherapy |
| Address |
Advanced physiotherapy center, room no. 39, sagar floor, KLE Dr Prabhakar Kore Hospital Belgaum Karnataka 590010
Belgaum karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeyooshagurudut@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Peeyoosha Gurudut |
| Designation |
Professor |
| Affiliation |
KLE Institute of physiotherapy |
| Address |
Advanced physiotherapy center, room no. 39, sagar floor, KLE Dr Prabhakar Kore Hospital Belgaum Karnataka 590010
Belgaum karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeyooshagurudut@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar Kore Hospital and research centre, Nehru nagar, Belagavi |
|
|
Primary Sponsor
|
| Name |
KLE Academy f higher education and research |
| Address |
Nehru nagar belgavi Karntaka |
| Type of Sponsor |
Private medical college |
|
|
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 Vaishnavi Aghav |
KAHER Institute of Physiotherapy |
Advanced physiotherapy center, room no. 39, sagar floor, KLE Dr Prabhakar Kore Hospital Belgaum Karnataka 590010
Belgaum
KARNATAKA |
9156948349
vaishnaviaghav1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical committee KAHER institute of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M70-M79||Other soft tissue disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Egoscue exercises |
intervention will be given for35 minutes 3 times/week, for four weeks |
| Intervention |
Global postural re-education |
Intervention will be given for 35 minutes 3 times/ week, for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of Upper cross syndrome with having atleast any one symptom from major criteria and one symptom from minor criteria
Participants aged between 20 to 50 years of either gender.
Participants willing to participate in the study and who can comprehend the commands. |
|
| ExclusionCriteria |
| Details |
any diagnosed muscle pathology or disease of soft tissues, fracture of spine, or spinal deformity
Diagnosed pathology like malignancy, and inflammatory disorders or vertebral artery insufficiency
Any history of spine disease, osteoporosis, blood diseases, and uncontrolled hypertension
History of any upper limb , lower limb, spinal or cardiothoracic surgery
Neuromuscular disorders, cognitive impairment and pregnancy
Undergoing any other recent therapeutic management within 3 months will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Cranio-vertebral angle(CVA) Pectoralis Minor Index(PMI)
|
Pre- baseline at day 1
Post baseline after 12 days of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Deep cervical flexor endurance test
Tragus to wall test
Neck Disability Index(NDI)
Patient satisfaction scale
|
Pre- baseline at day 1
Post baseline after 12 days of intervention |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/11/2023 |
| Date of Study Completion (India) |
30/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/03/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
TITLE : Global Postural Re-education versus Egoscue exercises in Upper Cross Syndrome on neck pain, forward head and rounded shoulder posture - A Randomised Clinical Trial
Objective of the study : To determine and compare the effect of Global Postural Re-education and Egoscue exercise in Upper Cross Syndrome in terms of neck pain and functional ability using Neck disability index, forward head using kinovea app by measuring craniovertebral angle and rounded shoulder posture using pectoralis minor index Inclusion criteria: Clinically diagnosed cases of Upper cross syndrome with having atleast any one symptom from major criteria and one symptom from minor criteria Participants aged between 20 to 50 years of either gender. Participants willing to participate in the study and who can comprehend the commands. Exclusion criteria : any diagnosed muscle pathology or disease of soft tissues, fracture of spine, or spinal deformity Diagnosed pathology like malignancy, and inflammatory disorders or vertebral artery insufficiency Any history of spine disease, osteoporosis, blood diseases, and uncontrolled hypertension History of any upper limb , lower limb, spinal or cardiothoracic surgery Neuromuscular disorders, cognitive impairment and pregnancy Undergoing any other recent therapeutic management within 3 months will be excluded.
Procedure Group A - Global postural Re-education Group B - Egoscue exercises Both the groups will be given a common treatment in the form of Interferential therapy and Hot moist pack Intervention will last for 35 minutes for each group
|