| CTRI Number |
CTRI/2024/09/073427 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
01/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check the effect of Janda Approach on Text Neck Syndrome in college going Students |
|
Scientific Title of Study
|
Effect of Janda Approach on Text Neck Syndrome among University Students a Randomized Clinical 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 |
Shavez |
| Designation |
MPT Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room no 06, General OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
7835882124 |
| Fax |
|
| Email |
shavezmansoori0786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunita Sharma |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Sunita Sharma |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shavez |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana |
| 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 Sunita Sharma |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Room no 06 General OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Ambala
HARYANA |
9467633734
drsunita.sharma@mmumullana.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Maharishi Markandeshwar Institute of Medical Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Text Neck Syndrome |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Therapy |
Hot pack fermentation: The hot pack is applied to the neck either supine or prone position according to the individual comfortability after being wrapped adequately in towel or blanket, Care must be taken to have a layer of towel and to avoid excessive pressure by weight being placed on bony points.
Neck Isometrics exercises: (neck flexion, extension, lateral flexion)- Bend the neck slightly forward and put the hands on forehead, Try to bend head forward while pushing back with the hands, Keep body up and the neck straight and place the hands at the back of head, Try to push head backwards while pushing forward with the hands Duration- 3 sessions per week for four weeks of 30 to 45 minutes |
| Intervention |
Janda Approach along with Conventional Therapy |
Dynamic isometric exercise for flexion of the neck, Post isometric Relaxation Exercises, Spinal Stabilization, Sensorimotor Training, Conventional therapy (described below)
Duration- 3 sessions per week for four weeks of 30 to 45 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
age group of 18 to 35 years, both male and female, Visual analogue scale score greater than 3, based on short version of smartphone addiction scale score greater than 23, craniovertebral angle less than 50 degree, neck disability index score greater than 10 |
|
| ExclusionCriteria |
| Details |
Individuals having headache due to migraine, any fracture of cervical spine, osteoporosis, cervical stenosis, tumor, uncontrolled hypertension, prolonged use of steroid, history of whiplash injury, Past surgical interventions, Patient having torticollis, and scoliosis, cervical radiculopathy symptoms
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale
Pressure Biofeedback |
Baseline, 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Universal Goniometer
Neck Disability Index |
Baseline and 4th week |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
26/09/2024 |
| 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="6"
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
|
ABSTRACT Background: Text neck syndrome describes an overuse injury of the cervical spine resulting from the repetitive stress of prolonged forward head flexion while looking down on a mobile screen. If left insufficiently treated, the text neck syndrome can worsen over time, causing a multitude of physical health problems such as cervical curvature alteration, neck and shoulder muscle strain, impaired neck muscle perception, posterior ligamentous injury, and entrapment neuropathies. Purpose: The aim of this study is to find out the effect of Janda approach in individuals with Text Neck Syndrome. Methods: Patients will be recruited based on selection criteria. Subjects will be randomly allocated into group 1 and group 2 through computer based random allocation techniques. Group 1 will receive Janda Approach and group 2 will receive conventional treatment (hot fermentation, neck isometrics) only Pre-test and post-test assessment will be done by using visual analogue scale (VAS), Neck disability Index (NDI), Inclinometer, pressure biofeedback. The treatment will be given for 3 days a week for 4 consecutive weeks. Data Analysis: Data will be analyzed using the Statistical Package for Social Sciences (SPSS) software. Shapiro - Wilk test will be used to establish the normality of the data. If data is found to be normally distributed it will be presented as mean±SD and paired t-test will be used for within the group analysis and unpaired t-test will be used for between the group analysis. If data is found to be not normally distributed it will be presented as Median (Interquartile range) and wilcoxon rank test will be used for within the group analysis and mann whitney U test will be used for between the group analysis. Keywords: Overuse injury, cervical spine, biofeedback, entrapment neuropathies |