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CTRI Number  CTRI/2026/03/105395 [Registered on: 05/03/2026] Trial Registered Prospectively
Last Modified On: 03/03/2026
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   Effect Of Instrument-Assisted Soft Tissue Mobilization vs. Massage for Neck Pain, Range Of Motion And Function In College Students With Text Neck Syndrome. 
Scientific Title of Study   Effect Of Instrument Assisted Soft Tissue Mobilization Compared To Massage Manipulation On Neck Pain, Range Of Motion And Function In College Going Individuals With Text Neck Syndrome. A Single Blinded 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  Jay Ganesh Jambhe 
Designation  PG students 
Affiliation  College Of Physiotherapy, Sumandeep Vidyapeeth Deemed To be University 
Address  PG1 classroom, 2nd floor, department of musculoskeletal disorders and sports, college of physiotherapy, Sumandeep Vidyapeeth, Pipariya, Waghodia, Vadodara, Gujarat, 391760, India

Vadodara
GUJARAT
391760
India 
Phone  9867388840  
Fax    
Email  jayjambhe1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Noel Macwan 
Designation  Assistant Professor 
Affiliation  College Of Physiotherapy, Sumandeep Vidyapeeth Deemed To be University 
Address  Staff room, Ground floor, department of musculoskeletal disorders and sports, college of physiotherapy, Sumandeep Vidyapeeth, Pipariya, Waghodia, Vadodara, Gujarat, 391760, India

Vadodara
GUJARAT
391760
India 
Phone  9898072014  
Fax    
Email  noel.cop@sumandeepvidyapeethdu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Noel Macwan 
Designation  Assistant Professor 
Affiliation  College Of Physiotherapy, Sumandeep Vidyapeeth Deemed To be University 
Address  Staff room, Ground floor, department of musculoskeletal disorders and sports, college of physiotherapy, Sumandeep Vidyapeeth, Pipariya, Waghodia, Vadodara, Gujarat, 391760, India


GUJARAT
391760
India 
Phone  9898072014  
Fax    
Email  noel.cop@sumandeepvidyapeethdu.edu.in  
 
Source of Monetary or Material Support  
Self funded as no funding is being provided  
 
Primary Sponsor  
Name  Jay Ganesh Jambhe 
Address  PG1 classroom, 2nd floor, department of musculoskeletal disorders and sports, college of physiotherapy, Sumandeep Vidyapeeth, Pipariya, Waghodia, Vadodara, Gujarat, 391760 , India 
Type of Sponsor  Other [Self funded] 
 
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 
Dr Jay Ganesh Jambhe  Sumandeep Vidyapeeth Deemed to be University  Constituent institutes of Sumandeep Vidyapeeth, Sumandeep Vidyapeeth Deemed to be University campus, Waghodia, Pipariya, Vadodara, Gujarat, 391760, India
Vadodara
GUJARAT 		 9867388840

jayjambhe1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  College Going Individuals With Text Neck Syndrome 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Instrument Assisted Soft Tissue Mobilization  Instrument Assisted Soft Tissue Mobilization will be given for 3 sessions per week 12 days. Strokes will be at an angle of 45 degrees with skin contact, each stoke lasting 6-10 seconds for 3 minutes per session. 
Intervention  Massage Manipulation  Powder will be applied as lubricant and effleurage will be given followed by thumb kneading for 30 minutes each session for 3 sessions per week for 12 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1) College going individuals between the age groups 18 to 30 of both genders.
2) Individuals screened and fit the criteria for text neck syndrome.
 
 
ExclusionCriteria 
Details  1)Individuals with Degenerative cervical spine conditions
2)Individuals who have undergone chest or neck surgeries in past 3 months
3)Individuals who have undergone Corticosteroid therapy in past 3 months
4)Individuals with skin conditions like: eczema, open wounds, burns.
5)Individuals with malignant conditions
6)Individuals with excessive hair around neck region
7)Individuals with acute inflammatory conditions like skin rash, localized inflammation.
8)Individuals having neck pain for less than two weeks or more than three months 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Range of Motion by Goniometer, NPRS, Neck Disablity Index  Day 1, Day 6, Day 12 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   07/04/2026 
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   The study aims to see the effect of Instrument Assisted Soft Tissue Mobilization in comparison to Massage Manipulation for neck pain, range of motion and function in College going individuals in text neck syndrome. As both these techniques have been proven to be effective, there is dearth of studies that compare both these techniques. This makes it important to understand the reliability of these techniques for better management in text neck. 
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