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CTRI Number  CTRI/2012/05/002619 [Registered on: 01/05/2012] Trial Registered Retrospectively
Last Modified On: 27/01/2015
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Randomized Trial to Assess the Effect of Neural Mobilization Techniques in Hamstring flexibility 
Scientific Title of Study   Effect of Neural Mobilization as an Adjuvant to Static Stretching on Hamstring Flexibility: A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saurab Sharma 
Designation  Post Graduate 
Affiliation  Manipal College of Allied Health Sciences (MCOAHS) 
Address  Department of Physiotherapy, Manipal College of Allied Health Sciences (MCOAHS), Manipal University, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9986279883  
Fax    
Email  saurabsharma1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ganesh Balthillaya 
Designation  Assistant Professor 
Affiliation  Manipal College of Allied Health Sciences (MCOAHS) 
Address  Department of Physiotherapy, Manipal College of Allied Health Sciences (MCOAHS), Manipal University, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448263631  
Fax    
Email  ganeshbm2000@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Saurab Sharma 
Designation  Post Graduate 
Affiliation  Manipal College of Allied Health Sciences (MCOAHS) 
Address  Department of Physiotherapy, Manipal College of Allied Health Sciences (MCOAHS), Manipal University, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9986279883  
Fax    
Email  saurabsharma1@gmail.com  
 
Source of Monetary or Material Support  
Manipal University 
 
Primary Sponsor  
Name  Manipal University 
Address  Departmentt of Physiotherapy , Manipal University of Allied Health Sciences, Manipal University,Manipal-576104 Udupi KARNATAKA  
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 
Saurab Sharma  Department of Physiotherapy, Manipal College of Allied Health Sciences  Manipal University,Madhav Nagar, Manipal - 576104
Udupi
KARNATAKA 
9986279883

saurabsharma1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Indivigual with hamstring muscle tightness otherwise, Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Slider technique and Static stretching   Individual will be given static stretching with 30 second hold by the investigator. 3 sets of Slider technique will be given for 10, 15 and 20 repetitions respectively with 30-45 seconds of rest period.  
Comparator Agent  static streching only  Individual will be given static stretching with 30 second hold by the investigator.  
Intervention  Tensioner technique and static stretching   Shacklocks tensioner technique along with static stretching will be given  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details 
• Individuals with reduced Hamstring flexibility (knee extension angle more than 20 degrees
 
 
ExclusionCriteria 
Details  •Medical illness including orthopaedic and neurological diseases
•Past surgeries on spine and lower extremity
•Any low back pain or leg pain during the time of study
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Knee Extension Angle  Baseline Measurement
Measurements will be taken after each intervention i.e. on 1st, 4th and 7th day.  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/04/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Introduction:

Hamstring injury has always been most frustrating injury in sports. It is the commonest sports injury. It accounts for 10-30% of all sports injuries. Moreover, the risk of re-injury is even higher i.e. 12-31%. Also, the severity of recurrence is significantly higher than the initial injury. The incidence of injury and re-injury of hamstring in sports has not reduced in past three decades. All these findings suggest that prevention of hamstring injuries is absolutely important. Studies have shown that hamstring tightness causes the increased risk of hamstring injury and also causes low back pain. Along with hamstring tightness, adverse neural tension is also a contributing factor of hamstring injury. Thus, along with stretching hamstring muscle for preventing its injury, addressing neural component is also equally essential, which could be the solution to recurrent hamstring injuries. 

So, addressing the hamstring flexibility by targeting the nerve can be a good option to explore as this has not been looked at before. Static stretching being the most common intervention given for improving and maintaining hamstring length, we are providing the giving static stretching to all the three groups, out of which third group is an active control group. First group will receive mobilization technique (slider) while the second group will receive tensioner type of neural mobilization technique both of which are techniques described by Shacklock. Also, we are comparing the effect of the two types of neural mobilization techniques for their efficacy compared to themselves, along with checking if neural mobilization have any added benefit over static stretching in improving hamstring flexibility. 

NEED FOR THE STUDY:

•       Added benefit of neural mobilization over static stretching in hamstring flexibility has not yet been studied.

•       Among the two types of neural mobilization techniques, which technique is better to improve hamstring flexibility is unexplored so far.

CLINICAL SIGNIFICANCE:

·         Neural mobilization if proved to be effective, will improve the hamstring flexibility in normal adults, and thus contribute in decreased incidence of hamstring injuries and low back pain.

·         Result will help clinician in decision making, whether or not to incorporate Neural mobilization techniques including sliders and tensioners in the flexibility exercises of hamstring.

·         If neural mobilization is found to improve hamstring flexibility, then adding neural mobilization to hamstring flexibility programme may be a major intervention in the improvement of hamstring flexibility and thus reduced hamstring injuries in sports and reduced over all incidence of low back pain.


 OBJECTIVE OF THE STUDY:                            

·         To investigate if neural mobilization has any added benefit over static stretching in improving hamstring flexibility.

·         To compare the efficacy of the two types of neural mobilization techniques (Slider and Tensioner) in improving hamstring flexibility. 

 METHODOLOGY:

Single-blinded Randomised Controlled Trial will be done on normal healthy individuals with limited hamstring flexibility in Manipal University, Karnataka. Knee extension angle will be used as the primary outcome measure which will be measured by blinded assessor by using two inclinometers. 

60 volunteer participants will be randomly divided into three groups using computer generated random number. 

Three groups are: 

1. Static stretching + Slider technique

2. Static stretching + Tensioner technique 

3. Static stretching only (control group) 

Intervention will be given for total of three days of week ie first, fourth and seventh day. In between the follow up time of one week, all participants will perform static stretching as the home exercise. Data will be analysed using appropriate statistical measures. 


 
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