| CTRI Number |
CTRI/2025/01/079831 [Registered on: 31/01/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of exercising at home for relieving neck pain and improve posture among mobile phone users |
|
Scientific Title of Study
|
Effectiveness of Home Exercise Program on Text Neck Syndrome and Posture Among Smartphone Users - A Pilot randomized controlled trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalini Santhosh |
| Designation |
Student |
| Affiliation |
GIMSR Medical College, GITAM University(Deemed to be university) |
| Address |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM (Deemed to be University), Gandhinagar, Rushikonda, Visakhapatnam
Visakhapatnam ANDHRA PRADESH 530045 India |
| Phone |
8897124226 |
| Fax |
|
| Email |
researchgitam24@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shalini Santhosh |
| Designation |
Student |
| Affiliation |
GIMSR Medical College, GITAM University(Deemed to be university) |
| Address |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM (Deemed to be University), Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh
Visakhapatnam ANDHRA PRADESH 530045 India |
| Phone |
8897124226 |
| Fax |
|
| Email |
researchgitam24@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nikhat Fatima |
| Designation |
Assistant Professor |
| Affiliation |
GIMSR Medical College, GITAM University(Deemed to be university) |
| Address |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM (Deemed to be University), Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh
Visakhapatnam ANDHRA PRADESH 530045 India |
| Phone |
9875452113 |
| Fax |
|
| Email |
fnikhat@gitam.edu |
|
|
Source of Monetary or Material Support
|
| Gandhi Institute Technology And Management (Deemed to be university) |
|
|
Primary Sponsor
|
| Name |
Shalini Santhosh |
| Address |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM (Deemed to be University), 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 |
| Shalini Santhosh |
Gandhi Institute of Technology And Management University |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM (Deemed to be University), Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh Visakhapatnam ANDHRA PRADESH |
8897124226
researchgitam24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GITAM Institute of Medical Sciences and Research, Rushikonda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Smartphone users with neck pain and poor posture |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Control group - Postural corrective advices along with Home exercise program |
The intervention group receives postural corrective exercises and Home exercise program which includes chin tuck exercises, Scapular stabilization exercises - Y to W, L to W and Scapular Retraction exercises, Active stretching exercises for Cervical flexors and Cervical extensors strengthening exercises. The protocol is followed for 6 weeks. |
| Comparator Agent |
Postural corrective advice |
The comparator group receives postural corrective advice which includes ergonomic postural corrections, and faulty postural corrections along with frequent alarm reminders. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Participants with neck pain.
Participants having screen time of more than 2 hours
NOTE: Screen time can be determined from the settings on individual smartphones. |
|
| ExclusionCriteria |
| Details |
Participants had neck pain with intensity (Numerical Pain Rating Scale) greater than 5
Participants having any neck complications or deformities
Participants who underwent any recent neck-related surgeries
Participants who were already a part of any similar research will be excluded.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Craniovertebral angle, Numerical pain rating scale, and Musculoskeletal assessment of the neck – Focusing on Cervical Range of Motion and Neck Disability Index |
Two-time points
Before the implementation intervention and after 6 Weeks of implementation of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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
|
Smartphones have become essential in everyday life, enhancing interaction and providing access to information, communication, online learning, and entertainment. However, prolonged use can lead to issues like neck pain and poor posture, often referred to as Text Neck Syndrome. Text Neck Syndrome results from maintaining a forward head posture while using smartphones, which increases stress on the cervical spine. This sustained posture can cause musculoskeletal symptoms and spinal problems, including a loss of the natural C-shaped curve in the cervical spine.
The widespread use of smartphones has been linked to an increase in cases of neck pain and poor posture, resulting in adverse effects on individuals’ well-being. Consequently, there is a need to conduct a study to develop individually tailored home exercise programs to alleviate discomfort and restore proper alignment. Hence, the study aims to know the impact of home exercise training on pain, function, and postural measures.
A pilot Randomized Controlled Trial is designed to assess the impact of home exercises on neck pain and posture. This study includes participants within the age group of 18 -30 years. On meeting the eligibility criteria, the screening process is done through digital questionnaires (relating to neck pain symptoms, and smartphone usage)which will be circulated around by displaying posters around the campus. The participants are then randomly allocated into 2 groups (comparator and intervention Group A and B respectively)by the chit method. The comparator group receives postural corrective advice while the intervention group receives postural corrective advice along with Home exercise program for 6 weeks. Participants in both groups will be advised to stay active and weekly reminders and feedback for group-specific activities. The study outcome measures will be administered at the time of recruitment and after completion of the study duration. The data will be collected and stored for analysis. |