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CTRI Number  CTRI/2020/09/027865 [Registered on: 17/09/2020] Trial Registered Prospectively
Last Modified On: 16/09/2020
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   Efficacy of two different stretching techniques on hamstring muscle flexibility in participants with mechanical low back pain 
Scientific Title of Study   Efficacy of self myofascial release technique versus mulligans two leg rotation technique on hamstring flexibility in participants with mechanical 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  NIKUNJ N VEKARIYA 
Designation  TUTOR CUM PHYSIOTHERAPIST 
Affiliation  CIVIL HOSPITAL, AHMEDABAD 
Address  B1 ward, Physiotherapy department, Civil hospital, Asarwa, Ahmedabad.

Ahmadabad
GUJARAT
380061
India 
Phone  7359238991  
Fax    
Email  nikunjvekariyapt@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr R K CHAVDA 
Designation  Professor and HOD, Medicine Department, Parul Institute of Medical Science and Researce 
Affiliation  Parul University 
Address  Parul Institute of Medical Science and Research, Limda, Waghodia, Vadodara

Vadodara
GUJARAT
380058
India 
Phone    
Fax    
Email  apc@paruluniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  NIKUNJ N VEKARIYA 
Designation  TUTOR CUM PHYSIOTHERAPIST 
Affiliation  CIVIL HOSPITAL, AHMEDABAD 
Address  B1 ward, Physiotherapy Department, Civil Hospital, Asarwa, Ahmedabad.

Ahmadabad
GUJARAT
380061
India 
Phone  7359238991  
Fax    
Email  nikunjvekariyapt@gmail.com  
 
Source of Monetary or Material Support  
B1 ward, Physiotherapy Department, Civil Hospital, Ahmedabad 
 
Primary Sponsor  
Name  NIKUNJ N VEKARIYA 
Address  B1 Ward, Physiotherapy Department, Civil Hospital, Ahmedabad. 
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 
NIKUNJ N VEKARIYA  CIVIL HOSPITAL AHMEDABAD  B1 Ward, Room No. 10, Physiotherapy Department, Civil hospital, Asarwa, Ahmedabad
Ahmadabad
GUJARAT 		 7359238991

nikunjvekariyapt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PARUL UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Mulligans two leg rotation technique  Both legs will be flexed so that the feet are off the plinth. Keeping his (subject’s) shoulders on the bed he takes his (subject’s) legs slowly to the side of the limited hamstring muscle flexibility. When he (subject) reaches limit, the position is sustained for 30 seconds with over pressure applied by the therapist then back to starting position and repeat for 3 repetitions, and 1 minute rest between each stretch. And same procedure is done for the other side of limited hamstrings flexibility. 
Intervention  Self myofascial release technique  It is a technique to roll a tennis ball on the sole of each foot from behind the metatarsal heads to the heel concentrating on the medial arch for two minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Low back pain with no specific pathology
Low back pain less than 6 weeks
Active knee extension measurement more than 15 degree 
 
ExclusionCriteria 
Details  Participants with Low back pain with trauma
Low back pain with specific pathology
Any neurological symptoms involving prolapsed IV disc, Radiating pain
History of any recent Abdominal, Back surgeries
Pregnancy, Psychological risk factor, Participants apprehensive for Stretching technique 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain on Visual Analogue scale
Active knee extension test using universal goniometer
Gujarati version of Oswestry Disability index 		 At Baseline, 1 week 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   20/09/2020 
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  
        Low back pain (LBP) is a problem worldwide with a lifetime prevalence reported to be as high as 84% by World Health Organization (WHO).Muscle flexibility is defined as “The ability of a muscle to lengthen allowing one joint (or more than one joint in series) to move through range of motion”. Flexibility is vital for all movements and changes in flexibility may cause abnormal loading of the musculoskeletal system which could lead to injury. Decreased hamstring flexibility is considered to be a predisposing factor for lower back pain, participants with lower back pain were found with tightness in their hamstrings.
        Among the various stretching techniques, Mulligan’s Two leg Rotation is found to be one of the most common and effective technique that improves hamstring flexibility. On the other hand recent advances have shown that self myofascial release is an effective means of stretching which has also been proved to produce beneficial effects in improving hamstring flexibility. Beside this there are no studies done by comparing the effect of self myofascial release and mulligan’s two leg rotation technique in hamstring flexibility in mechanical low back pain participants and hence there exists a need for this study to find out the superior form of technique in improvement of hamstring flexibility in mechanical low back pain participants.
        In this experimental study, 100 participants with mechanical low back pain fulfilling the inclusion criteria will be selected using simple random sampling method and randomly will be divided into 2 groups i.e. Group A and Group B, each group consists of 50 members. Following their selection a written informed consent will be obtained from each of them. Baseline Measurements prior the treatment will be conducted on both groups that is VAS for Pain, ODI for functional disability index, AKE measurement for hamstrings flexibility and these outcomes will be assessed again on 7th day post treatment. Group A will be received Self myofascial release technique and Group B will be received Mulligan’s two leg rotation technique. Along with this both groups will receive SWD for lower back region for 10 minutes, isometric back exercise, bridging, abdominal curl-up, supine SLR, prone back extension, prone SLR and quadruped arm and leg lift in cross manner. The results will be recorded and statistically analyzed.
 
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