| CTRI Number |
CTRI/2025/07/091501 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on the Effect of neck and shoulder strengthening exercises using elastic bands in female students with text neck syndrome |
|
Scientific Title of Study
|
Effect of cervical-scapular stabilization with graded isotonic elastic band exercises on neck pain, disability and posture among female students with text neck 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 |
Poushali Ghosh |
| Designation |
Masters of Physiotherapy Student |
| Affiliation |
Galgotias University |
| Address |
Galgotias University, Plot no. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8882447177 |
| Fax |
|
| Email |
poushalig81@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Sharma |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Galgotias University, Plot no. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9811162111 |
| Fax |
|
| Email |
vikassharma.smas@galgotiasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas Sharma |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Galgotias University, Plot no. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9811162111 |
| Fax |
|
| Email |
vikassharma.smas@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Galgotias University, Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Galgotias University, Plot no. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh |
| Type of Sponsor |
Research institution |
|
|
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 Poushali Ghosh |
Galgotias University |
Galgotias University, Plot no. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
8882447177
poushalig81@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M530||Cervicocranial syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cervical-scapular stabilization exercises and graded isotonic elastic band exercises |
Intervention group will receive cervical-scapular stabilization exercises combined with graded isotonic elastic band exercises. Exercises will be administered under supervision having 3 sessions per week for 6 weeks. The program will include progressive resistance training using elastic band and neck and scapular stabilization exercises.
|
| Comparator Agent |
Conventional Physiotherapy |
Control group will receive conventional physiotherapy. This will include hot pack application followed by neck isometrics and stretching of neck muscles along with postural correction instructions. The duration of this will match the intervention group which is 3 sessions per week for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Female students aged 18 to 25 years
Clinical signs of forward head posture and neck pain
Average screentime of more than 5 hours a day
Pain duration of more than 4 weeks
VAS pain score more than or equal to 5 |
|
| ExclusionCriteria |
| Details |
Cervical spine trauma or deformities
Neurological symptoms
History of cervical surgery
Ongoing physiotherapy treatment for other conditions
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain, posture and neck disability |
Baseline, 2 weeks, 4 weeks and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
01/09/2025 |
| 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="0"
Months="3"
Days="0" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [poushalig81@gmail.com].
- For how long will this data be available start date provided 21-06-2026 and end date provided 21-07-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This randomized controlled trial aims to evaluate
the effect of Cervical-scapular stabilization combined with graded isotonic elastic band
exercises on neck pain, functional disability, and postural alignment among female students
with text neck syndrome. The study will include female participants aged between 18 and 25 years who reports prolonged use of smartphones or digital devices associated with neck pain and forward head posture. Participants will be randomly allocated into two groups. One group will receive cervical-scapular stabilization with elastic band exercises, while the control group will receive conventional physiotherapy. The intervention will be carried out for 6 weeks, and outcome measure such as pain, neck disability index, and postural alignment will be recorded at baseline, 2 weeks, 4 weeks and 6 weeks of intervention. The results will help determine whether combination of cervical - scapular stabilization and elastic band exercises is effective in reducing symptoms and improve posture in female students with text neck syndrome. |