| CTRI Number |
CTRI/2025/11/096898 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
03/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out the effect of Super Inductive System therapy on people with Text Neck Syndrome |
|
Scientific Title of Study
|
Effect of Super Inductive System Therapy on Text Neck Syndrome:A Randomised 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 |
Dr Varun Naik |
| Designation |
Assistant professor of CVTS physiotherapy |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLE Institute of Physiotherapy,Nehru Nagar,Belagavi,Karnataka,India
Belgaum
KARNATAKA
590010
India |
| Phone |
9986497065 |
| Fax |
|
| Email |
varunnaik@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun Naik |
| Designation |
Assistant professor of CVTS physiotherapy |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLE Institute of Physiotherapy,Nehru Nagar,Belagavi,Karnataka,India
Belgaum
KARNATAKA
590010
India |
| Phone |
9986497065 |
| Fax |
|
| Email |
varunnaik@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Pallavi Ippagunta |
| Designation |
Intern |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
Physiotherapy OPD number 39, G-1 floor,KLE Dr.Prabhakar Kore hospital and Medical Research Centre,Belagavi ,Karntaka ,India
Belgaum
KARNATAKA
590010
India |
| Phone |
7738842958 |
| Fax |
|
| Email |
pallaviir9@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr. Prabhakar Kore Hospital and Research Centre,N Nehru Nagar, Belagavi, 590010,India |
|
|
Primary Sponsor
|
| Name |
KLE Dr.Prabhakar Kore,Hospital Belagavi |
| Address |
Sagar floor,Advacned Physiotherapy Centre, room no39
KLE Dr.Prabhakar Kore Hospital,MRC Nehru Nagar Belagavi 590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Varun Naik |
KLE Dr. Prabhakar Kore Hospital |
department of Cardiovascular and pulmonary Physiotherapy room no 6, KLE hospital, JNMC campus Nehru Nagar ,Belgaum
Belgaum
KARNATAKA |
9986497065
varunnaik@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee KLE Institute of Physiotherapy |
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 |
| Intervention |
Group A Super Inductive System Therapy with exercises |
The Subjects in Group A will receive Super Inductive System Therapy(frequency-1 to 150 hertz) over posterior part of neck for 10 to 20 mins along with exercises |
| Comparator Agent |
Group B Conventional physiotherapy with exercises |
Group B will receive Conventional Physiotherapy TENS (frequency- 80 to 120 hertz) for 15-20 mins along with exercises |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Text Neck Syndrome |
|
| ExclusionCriteria |
| Details |
Implants , pregnancy , recent surgery,open wounds |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Craniovertebral angle measurement using kinovea software |
pre and post assesment will be taken on day 1 and post assessment on day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
25/11/2025 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- 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 (Others) -
- For how long will this data be available start date provided 15-10-2025 and end date provided 15-04-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
OBJECTIVE To determine effect of Super Inductive System Therapy on pain, cervical range of motion, forward neck posture and quality of life using pressure-pain threshold algometer, craniovertebral angle using Kinovea software. To compare the effect of Super Inductive System Therapy with conventional physiotherapy using pressure-pain threshold algometer, craniovertebral angle using kinovea software
INCLUSION CRITERIA
Age 18 to 25 years all genders Pain intensity Visual analog scale more than 4 on scale of 0 to 10 the past week Clinical diagnosis of text neck syndrome forward neck posture less than 50 degrees chronic or recurrent neck pain 3 months associated with prolonged smartphone/computer use Diagnosed cases of Text neck syndrome from physiotherapist Stable Habits using digital devices more than 3 hours for at least 6 months Participants willingness to be a part of the research study
EXCLUSION CRITERIA Implanted electronic or metallic devices in the head or neck or chest region History of seizure /epilepsy Pregnancy Acute trauma or fracture in the cervical spine within the past 6 months Recent surgery Skin lesions or open wounds over treatment area OUTCOME MEASURES
Craniovertebral angle using Kinovea®software
pressure pain threshold using a pain pressure algometer
Neck disability Index
Procedure: GROUP A the subject with text neck syndrome will be receiving Super Inductive System therapy over the posterior neck region for 10 to 20 minutes along with exercises
GROUP B the subject with text neck syndrome will be receiving conventional physiotherapy over the posterior neck region for 10 to 20 minutes with exercises
|