| 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
|
|
|
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
|
|
|
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
|
|
|
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
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
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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 |
|
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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
|
|
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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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