| CTRI Number |
CTRI/2025/01/079741 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
The Effect of Posture Correction on low back pain in computer workers |
|
Scientific Title of Study
|
Effect of postural awareness on desktop workers with mechanical low back pain a cohort study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarmista Patro |
| Designation |
student |
| Affiliation |
Gitam School of Physiotherapy |
| Address |
Room no1, department of Physiotherapy, School of physiotherapy, GITAM institute of medical sciences and research, Gandhi Nagar, Rushikonda,Vishakapatnam.
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9178344647 |
| Fax |
|
| Email |
sarmistapatrodr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sarmista Patro |
| Designation |
student |
| Affiliation |
Gitam School of Physiotherapy |
| Address |
Room no1, department of Physiotherapy, School of physiotherapy, GITAM institute of medical sciences and research, Gandhi Nagar, Rushikonda,Vishakapatnam.
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9178344647 |
| Fax |
|
| Email |
sarmistapatrodr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vineel Pedapenki |
| Designation |
Assistant Professor |
| Affiliation |
Gitam School ofPhysiotherapy |
| Address |
Room no1, department of Physiotherapy, School of physiotherapy, GITAM institute of medical sciences and research, Gandhi Nagar, Rushikonda,Vishakapatnam.
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9620094276 |
| Fax |
|
| Email |
vpedapen@gitam.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sarmista Patro |
| Address |
GITAM School of Physiotherapy
4th Floor GIMSR Medical college Building
GIMSR Campus
Gandhinagar Rushikonda Visakhapatnam 530045
Andhra Pradesh |
| Type of Sponsor |
Other [self] |
|
|
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 Vineel Pedapenki |
GITAM Deemed to be University |
GITAM School of Physiotherapy
4th Floor GIMSR Medical college Building
GIMSR Campus
Gandhinagar Rushikonda Visakhapatnam 530045
Andhra Pradesh
Visakhapatnam
ANDHRA PRADESH |
9620094276
vpedapen@gitam.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee GIMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Low back pain
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Participants with the age of 30 - 45 years old, nonspecific low back pain, both male and female, desktop workers spending 8 hours or more than that in the sitting position. Individuals with self-reported. |
|
| ExclusionCriteria |
| Details |
Cervical and thoracic pain, pregnant women or recent childbirths, Individuals with congenital spine abnormalities, or any history of spinal trauma in the past 1-2 years. NPRS greater than 5 participants who are already aware of the right ergonomical postures. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Questionnaire for desktop workers with low back pain and Posture Awareness Questionnaire |
At baseline and 4th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
28/02/2025 |
| 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="1"
Months="0"
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
|
The aim of our study is to know effect of posture awareness on low back pain with in desktop workers. The type of the study is cohort study and the procedure involves, initially identifying desktop workers; providing the screening questionnaire to the desktop workers; screening participants according to the inclusion criteria; enroll eligible participants in the study; participants will be briefed on the study’s purpose and procedures, obtaining the consent; will educate participants on the importance of sitting posture; explain how proper sitting posture can prevent musculoskeletal disorders, improve comfort, and enhance productivity; implement corrections in sitting posture and provide ergonomic adjustments, chair recommendations, and posture exercises; follow up for few weeks by reminding adherence to posture corrections and provide additional guidance as needed; reevaluate the effects by providing the questionnaire again and check the overall results. |