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CTRI Number  CTRI/2023/05/052764 [Registered on: 17/05/2023] Trial Registered Prospectively
Last Modified On: 16/05/2023
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   To see the effects of IASTM on pain, range of motion and level of function in ADLs in subjects with low back pain.  
Scientific Title of Study   EFFECTS OF INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION ON PAIN, RANGE OF MOTION AND LEVEL OF FUNCTION IN ACTIVITIES OF DAILY LIVING IN PATIENTS WITH LOW BACK PAIN 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vandit Gandhi  
Designation  PG Student 
Affiliation  College of Physiotherapy Sumandeep Vidyapeeth Deemed to be University  
Address  Room No-410, Department of musculoskeletal disorders, College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At & PO Pipariya, Ta. Waghodia, Vadodara Gujarat 391760

Vadodara
GUJARAT
391760
India 
Phone  9429160111  
Fax    
Email  vanditgandhi2015@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  Department of musculoskeletal disorders, College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At And Post Pipariya, Taluka-Waghodia, Vadodara Gujarat 391760

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  Department of musculoskeletal disorders, College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At And Post Pipariya, Taluka-Waghodia, Vadodara Gujarat 391760

Vadodara
GUJARAT
391760
India 
Phone  9898072014   
Fax    
Email  noel.cop@sumandeepvidyapeethdu.edu.in  
 
Source of Monetary or Material Support  
Room No-410, Physiotherapy OPD, Dhiraj hospital, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At And Post Pipariya, Taluka-Waghodia, Vadodara Gujarat 391760 
 
Primary Sponsor  
Name  Vandit Gandhi 
Address  College Of Physiotherapy, Sumandeep Vidyapeeth (Declared as deemed to be University u/s 3 of UGC act1956) Pipariya, Tal. -Waghodia, Dist-Vadodara, Gujarat-391760 
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 
Vandit Gandhi  Dhiraj hospital  Sumandeep Vidyapeeth (Declared as deemed to be University u/s 3 of UGC act1956) Pipariya, Tal. -Waghodia, Dist-Vadodara, Gujarat-391760
Vadodara
GUJARAT 
9429160111

vanditgandhi2015@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep vidyapeeth Institutional Ethics Committee (SVIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M628||Other specified disorders of muscle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  EFFECTS OF INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION ON PAIN, RANGE OF MOTION AND LEVEL OF FUNCTION IN ACTIVITIES OF DAILY LIVING IN PATIENTS WITH LOW BACK PAIN  WE ARE GOING TO STUDY THE EFFECTS OF INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION ON PAIN, RANGE OF MOTION AND LEVEL OF FUNCTION IN ACTIVITIES OF DAILY LIVING IN PATIENTS WITH LOW BACK PAIN FOR TWO TIMES IN A WEEK 
Intervention  IASTM on low back pain  Patient position: Prone lying with arms at the sides of the body and legs parallel to each other. The patient was undressed enough to access the thoracolumbar fascia (TLF) between T12 and S1. At the beginning of an IASTM Technique treatment, the therapist will rub the adhesion to encourage mobility. With the aid of a convex metal therapy tool, a physiotherapist used IASTM. During this technique, the tool was moved paravertebrally at a speed of 3 cm/s on both sides of the TLF in a craniocaudal direction. Prior to treating the muscles in a direction perpendicular to the muscle fibres, IASTM was administered in a direction parallel to the muscle fibres being treated with the instrument at a 45° angle. The entire intervention lasted three minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age group of between 18 to 60 years
Patient with low back pain for less than 12 weeks
Both Genders
Patient should understand the consent form and read & write in the language comfortable to him/her that is in English, Hindi or Gujarati
 
 
ExclusionCriteria 
Details  Redness on low back region
Patient who has undergone a surgical procedure for low back
Spine fracture
Spinal tumor
Unilateral or bilateral radiating symptom
Sciatic nerve damage
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Modified Schober’s test for Range of Motion
Visual Analog Scale for Pain Oswestry Disability Index for Function of Activities of Daily Living
 
TWO TIMES INITIALLY AND END OF ONE WEEK 
 
Secondary Outcome  
Outcome  TimePoints 
Modified Schober’s test for Range of Motion
Oswestry Disability Index for Function of Activities of Daily Living
 
TWO TIMES INITIALLY AND END OF ONE WEEK 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 1/ Phase 2 
Date of First Enrollment (India)   01/08/2023 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The study will be forwarded for Ethical approval to the Sumandeep Vidyapeeth Institutional Ethics Committee (SVIEC). Once the study is approved by Sumandeep Vidyapeeth Institutional Ethics Committee (SVIEC), participants will be approached and explained about the study. Those Participants who meet the inclusion criteria and who are willing to participate in the study, will be requested to fill the informed consent form (Annexure I). Participant information sheet (Annexure II) will be given to the participants. The participants will be screened as per assessment sheet (Annexure III). Once the assessment is completed the patient will be treated as per the treatment protocol.

In this study, participants will divide randomly by lottery method. Patients in both the groups (experimental and control group) will receive 2 days treatment in a week. 

 
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