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
|
|
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
|
|
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. |