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CTRI Number  CTRI/2024/09/073445 [Registered on: 05/09/2024] Trial Registered Prospectively
Last Modified On: 04/09/2024
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   Comparison of Effect of GT and PRT on pain, hamstrings flexibility and function in Bharatanatyam dancers with mechanical low back pain 
Scientific Title of Study   Comparison of Immediate Effect of Graston technique and Positional release technique on Pain, Hamstrings Flexibility and Function in Bharatanatyam dancers with Mechanical Low Back 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  Vasvi Hirenbhai Vora 
Designation  Post Graduate 
Affiliation  ahmedabad institute of medical sciences 
Address  AIMS Campus, Ahmedabad Institute of Medical Sciences, Nr. S.P. Ring Road, Ognaj Circle, Nr. Lions Karnavati Eye Hospital, Gota-Kalol Highway, Lapkaman, Ahmadabad

Ahmadabad
GUJARAT
380060
India 
Phone  9510270713  
Fax    
Email  vasvi.vora19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gopi Contractor 
Designation  Lecturer and PG Guide 
Affiliation  Ahmedabad Institute Of Medical Sciences 
Address  AIMS Campus, Ahmedabad Institute of Medical Sciences, Nr. S.P. Ring Road, Ognaj Circle, Nr. Lions Karnavati Eye Hospital, Gota-Kalol Highway, Lapkaman, Ahmadabad

Ahmadabad
GUJARAT
380060
India 
Phone  9924356309  
Fax    
Email  gtgopi2007@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gopi Contracto 
Designation  Lecturer and PG Guide 
Affiliation  Ahmedabad Institute Of Medical Sciences 
Address  AIMS Campus, Ahmedabad Institute of Medical Sciences, Nr. S.P. Ring Road, Ognaj Circle, Nr. Lions Karnavati Eye Hospital, Gota-Kalol Highway, Lapkaman, Ahmadabad

Ahmadabad
GUJARAT
380060
India 
Phone  9924356309  
Fax    
Email  gtgopi2007@gmail.com  
 
Source of Monetary or Material Support  
Ahmedabad Institute Of Medical Sciences Nr.S.P.Ring Road Ognaj Circal Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India 380060  
 
Primary Sponsor  
Name  Ahmedabad Institute Of Medical Sciences  
Address  Room no 1 Devision Exercise Therapy Department Physiotherapy Ahmedabad Institute Of Medical Sciences Nr.S.P.Ring Road Ognaj Circal Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India 380060 
Type of Sponsor  Private medical college 
 
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 gopi contractor  Ahmedabad Institute Of Medical Sciences  AIMS Campus, Ahmedabad Institute of Medical Sciences, Nr. S.P. Ring Road, Ognaj Circle, Nr. Lions Karnavati Eye Hospital, Gota-Kalol Highway, Lapkaman, Ahmadabad
Ahmadabad
GUJARAT 		 9924203981

gtgopi2007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional Research And Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Bharatanatyam dancers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Graston Technique  graston is a part of IASTM and it will be Given on hamstrings muscle and will be given for 90 seconds 
Comparator Agent  positional release technique  it will be given in patient supine with leg outside and flexed to 40 degrees and tender points will be palpated on medial and lateral hamstrings and treatment will be given for 90 seconds.  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. Age: 25 to 60 years.
2. Gender: Females only.
3. Subjects who have experience of more than 2 years in dancing.
4. Subjects who are dancing 1 or more than 1 hour per sessions in dancing.
5. Subjects who are dancing 2 or more than 2 sessions per week.
6. Subjects having low back pain.
7. visual analog scale Score 3 to 7
8. Subjects having up popliteal angle less than 145 degrees.
9. Subjects willing to participate.
 
 
ExclusionCriteria 
Details  1. Subjects having severe neurological, cardio-pulmonary and musculoskeletal condition.
2. Subjects having any skin conditions.
3. Surgery done in lower limb and back in the last 3 months.
4. History of fracture in lower limb in the last 3 months.
5. Subjects involved in various fitness activities.


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
popliteal angle  at baseline and immediately after treatment 
 
Secondary Outcome  
Outcome  TimePoints 
VAS  at baseline and immediately after treatment 
modified oswestry disability index  at baseline and immediately after treatment 
 
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)   01/03/2025 
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 - NO
Brief Summary  

AIMS:

 

To compare the immediate effect of Graston technique and positional release technique on pain, hamstrings flexibility and function in Bharatnatyam dancers with mechanical low back pain.

 

OBJECTIVES:

 

 

·          To study the immediate effect of Graston technique on pain by visual analogue scale in Bharatanatyam dancers with mechanical low back pain.

·         To study the immediate effect of Graston technique on hamstrings flexibility by popliteal angle in Bharatanatyam dancers with mechanical low back pain.

·         To study the immediate effect of Graston technique on function by modified Oswestry disability index in Bharatanatyam dancers with mechanical low back pain.

·         To study the immediate effect of positional release technique on pain by visual analogue scale in Bharatanatyam dancers with mechanical low back pain.

·         To study the immediate effect of positional release technique on hamstrings flexibility by popliteal angle in Bharatanatyam dancers with mechanical low back pain.

·         To study the immediate effect of positional release technique on function by modified Oswestry disability index in Bharatanatyam dancers with mechanical low back pain.

·         To study the immediate effect of Graston technique and positional release technique on pain in Bharatanatyam dancers with mechanical low back pain.

·         To compare the immediate effect of Graston technique and positional release technique on hamstrings flexibility in Bharatanatyam dancers with mechanical low back pain.

·         To compare the immediate effect of Graston technique and positional release technique on function in Bharatanatyam dancers with mechanical low back pain.

 
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