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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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