| CTRI Number |
CTRI/2025/04/085140 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| 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 to compare the effect of combined upper back and neck exercises versus neck exercises alone on neck pain and posture in college students with neck problems due to prolonged mobile phone use |
|
Scientific Title of Study
|
Effectiveness of thoracic extension exercise along with McKenzie exercise versus McKenzie exercise alone on pain, range of motion, forward head posture and functional disability in college students with text neck syndrome - a two arm parallel group randomized interventional 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 |
Devangi Dholakiya |
| Designation |
Post graduate student |
| Affiliation |
Shree Bhartimaiya College of optometry and physiotherapy |
| Address |
Physiotherapy department Shree Bharatimaiya college of physiotherapy surat
VESU MAIN ROAD,VRUDHASHRAM BEHIND BIG BAZAR PIPLOD, SURAT, GUJARAT
Surat
GUJARAT
395007
India |
| Phone |
9913652202 |
| Fax |
|
| Email |
devangidholakiya2101@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sapna Chaudhary |
| Designation |
Assistant Professor |
| Affiliation |
Shree Bharatimaiya college of Physiotherapy |
| Address |
Physiotherapy department Shree Bharatimaiya college of physiotherapy vesu surat
Surat
GUJARAT
395007
India |
| Phone |
9714750652 |
| Fax |
|
| Email |
sapnachaudhary1324@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Devangi Dholakiya |
| Designation |
Post graduate student |
| Affiliation |
Shree Bharatimaiya college of Physiotherapy |
| Address |
Physiotherapy department Shree Bharatimaiya college of physiotherapy vesu surat
Vesu Surat 395007
Surat
GUJARAT
395007
India |
| Phone |
9979397520 |
| Fax |
|
| Email |
devangidholakiya2101@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Bharatimaiya college of physiotherapy |
|
|
Primary Sponsor
|
| Name |
Devangi Dholakiya |
| Address |
Shree Bharatimaiya college of physiotherapy surat |
| 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 Devangi Dholakiya |
Bhartimaiya college of physiotherapy |
Physiotherapy department Vesu main road piplod Surat
Surat
GUJARAT |
9979397520
devangidholakiya2101@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITIONAL ETHICS COMMITTEE SHREE BHARTIMAIYA COLLEGE OF OPTOMETRY AND PHYSIOTHERAPY |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A-Mckenzie exercises combined with thoracic extension exercise |
Participants will perform a combined program of thoracic extension and McKenzie cervical exercises. The thoracic extension component includes three exercises using a foam roller, Swiss ball, and prone lifts, performed in 2 sets of 15 reps with 10-second holds. The McKenzie protocol will be conducted 3 times per week for 4 weeks and progresses through active movements (Week 1–2), overpressure techniques (Week 2–3), and postural endurance training (Week 3–4), with 15 reps per exercise and 7-second holds when applicable.
|
| Comparator Agent |
Group B-Mckenzie exercises |
The McKenzie protocol will be conducted 3 times per week for 4 weeks and progresses through active movements (Week 1–2), overpressure techniques (Week 2–3), and postural endurance training (Week 3–4), with 15 reps per exercise and 7-second holds when applicable. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. College students aged between 18 to 25 years
2. Both male and female
3. Participants with neck pain with NPRS between 4-6 [moderate]
4. Participants having forward head posture (CVA Less than 50 degrees) (28)
5. Frequent use of digital devices- regular use of smartphones, laptops, or tablets for at least 4 hours per day, which is commonly linked to the development of text neck syndrome.
6. A Neck Disability Index (NDI) score less than 24 mild to moderate disability score.
7. Willingness to participate
|
|
| ExclusionCriteria |
| Details |
1. Subjects will be excluded if they have a history of neck trauma or surgeryor with a medical diagnosis of musculoskeletal conditions ,neurological diagnosis over the neck region.
2. Participant who is on medications(pain killer).
3. Subjects with epilepsy.
4. Subjects with Vertigo
|
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| numerical pain rating score |
at baseline (pre intervention) and post intervention [4 weeks] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| cervical range of motion,postural alignment,functional limitations |
at baseline (pre intervention) and post intervention [4 weeks] |
|
|
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)
|
09/06/2025 |
| 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 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 - NO
|
|
Brief Summary
|
The study explores the effectiveness of combining thoracic extension exercises with McKenzie exercises versus McKenzie exercises alone in managing Text Neck Syndrome (TNS) among college students.The study follows a two-arm parallel group randomized interventional design and targets college students aged 18 to25 from Surat who exhibit moderate neck pain (NPRS score of 4to6), forward head posture (craniovertebral angle less than 50 degree), and mild to moderate neck disability. Participants will be randomly assigned to two groups: Group A will receive both thoracic extension and McKenzie exercises, while Group B will perform McKenzie exercises only. Both groups will undergo 12 intervention sessions over four weeks, with outcomes measured pre- and post-intervention.Primary outcome measures include pain intensity (Numeric Pain Rating Scale), while secondary outcomes assess cervical ROM (using a goniometer), postural alignment (craniovertebral angle via Kinovea software), and functional disability (Neck Disability Index). The aim is to evaluate whether the addition of thoracic extension exercises enhances the effectiveness of McKenzie exercises in reducing pain, correcting posture, and improving functional performance. The results aim to determine whether the combined intervention yields better improvements in posture, pain relief, and functionality than McKenzie exercises alone, thereby guiding optimal physiotherapy strategies for managing TNS in youth. |