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CTRI Number  CTRI/2025/07/091762 [Registered on: 25/07/2025] Trial Registered Prospectively
Last Modified On: 25/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of KIASTM and Motor Control Training Exercises in patients with chronic nonspecific neck pain 
Scientific Title of Study   Effectiveness of KIASTM and Motor Control Training Exercises in patients with chronic nonspecific neck pain 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lopa Das 
Designation  PhD Scholar 
Affiliation  Garden City University 
Address  Deprtment of Physiotherapy, School of Health Sciences,Garden City University,Bengaluru,Karnataka

Bangalore
KARNATAKA
560049
India 
Phone  9435552421  
Fax    
Email  ldas@rgu.ac  
 
Details of Contact Person
Scientific Query  
Name  Dr Shefali Raizada 
Designation  Assistant Professor 
Affiliation  Garden City University 
Address  School of Health Sciences,Garden City University,Bengaluru,Karnataka

Bangalore
KARNATAKA
560049
India 
Phone  9435552421  
Fax    
Email  shefali.raizada@gcu.edu.in  
 
Details of Contact Person
Public Query  
Name  Lopa Das 
Designation  PhD Scholar 
Affiliation  Garden City University 
Address  Department of Physiotheray, School of Health Sciences,Garden City University,Bengaluru,Karnataka

Bangalore
KARNATAKA
560049
India 
Phone  9435552421  
Fax    
Email  ldas@rgu.ac  
 
Source of Monetary or Material Support  
Physiotherapy out patient Department, The assam Royal Global University, Guwahati-35 
 
Primary Sponsor  
Name  Lopa Das 
Address  Garden City University, Bengaluru, Karnataka 
Type of Sponsor  Other [Self] 
 
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 Jahnabi Gogoi PT  The Assam Royal Global University  Physiotherapy OPD, Department of Physiotherapy, Block D Basement The Assam Royal Global University,Betkuchi, NH-37
Kamrup
ASSAM 		 8876404360

jgogoi@rgu.ac 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee for Human Research,RGU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION(IASTM), MOTOR CONTROL EXERCISE  IASTM WITH MOTOR CONTRL EXERCISES WILL BE GIVEN IN A GROUP OF 69 SUBJECTS. SUBJECTS WILL BE GIVEN 3 SESSIONS PER WEEK FOR A PERIOD OF 3 WEEKS.EACH SESSION WILL LAST FOR A DURATION OF 30 MINIUTES. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Subjects clinically diagnosed with chronic non specific neck pain with symptoms more than 3 months by physician
Subjects with negative spurling’s test
Age Group : 18-40
Both male and female subjects
Subjects who are willing to participate in the study.
 
 
ExclusionCriteria 
Details  Subjects with history of recent spinal surgery, spinal fractures ,any carcinogenic conditions ,
Subjects diagnosed with Cervical radiculopathy ,cervical myelopathy, Cervicogenic headache
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Outcome measures includes:
Visaul analogue scale
Range of Motion goniometry
Neck Disability Index
Deep Neck Flexor Testing
SF-36 score
Serum Biomarker level

 		 At baseline,3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="69"
Sample Size from India="69" 
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)   05/08/2025 
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)   Open to Recruitment 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ldas@rgu.ac].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 30-06-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The proposed study shall conclude a detailed analysis of finding an innovative treatment protocol for subjects suffering from chronic nonspecific neck pain. 
Use of advanced tools like Kinesio Instrument Assisted Soft Tissue Mobilization (KIASTM) and its effectiveness in treating nonspecific neck pain shall give more scope for managing other musculoskeletal conditions.
Addition of KIASTM tool for treating myofascial pain syndrome which is depicted as primary symptoms of nonspecific neck pain cases along with Motor Control Training Exercises will give a deeper insight into the literature concerning IASTM and also strengthening of deep neck muscles.
Application of Motor Control Training Exercises will address the motor control dysfunction issues which is profoundly associated among chronic nonspecific neck pain patients.
 
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