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CTRI Number  CTRI/2015/12/006448 [Registered on: 21/12/2015] Trial Registered Retrospectively
Last Modified On: 20/12/2015
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   Comparison of two treatment techniques for patients with low back pain. 
Scientific Title of Study   Comparison of Mulligans Bent Leg Raise Technique and Neural Sliding Technique on Straight Leg Raise in Non- Specific Low Back Pain patients: A Randomized Clinical Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Isha M Kurtkoti 
Designation  Student 
Affiliation  Kasturba Medical College 
Address  Department of Physiotherapy Kasturba Medical College Centre for Basic Sciences Bejai Mangalore Department of Physiotherapy Light house Hill road Hampankatta Mangalore Dakshina Kannada KARNATAKA
Department of Physiotherapy Kasturba Medical College Centre for Basic Sciences Bejai Mangalore Department of Physiotherapy Light house Hill road Hampankatta Mangalore Dakshina Kannada KARNATAKA
Dakshina Kannada
KARNATAKA
575004
India 
Phone  9890644115  
Fax    
Email  kurtkotiisha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Charu Eapen 
Designation  Associate Professor 
Affiliation  Kasturba Medical College 
Address  Department of Physiotherapy Kasturba Medical College Centre for Basic Sciences Bejai Mangalore Department of Physiotherapy Light house Hill road Hampankatta Mangalore Dakshina Kannada KARNATAKA
Department of Physiotherapy Kasturba Medical College Centre for Basic Sciences Bejai Mangalore Department of Physiotherapy Light house Hill road Hampankatta Mangalore Dakshina Kannada KARNATAKA
Dakshina Kannada
KARNATAKA
575004
India 
Phone  9986024551  
Fax    
Email  charu_mak@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Isha M Kurtkoti 
Designation  Student 
Affiliation  Kasturba Medical Colege 
Address  Department of Physiotherapy Kasturba Medical College Centre for Basic Sciences Bejai Mangalore Department of Physiotherapy Light house Hill road Hampankatta Mangalore Dakshina Kannada KARNATAKA
Department of Physiotherapy Kasturba Medical College Centre for Basic Sciences Bejai Mangalore Department of Physiotherapy Light house Hill road Hampankatta Mangalore Dakshina Kannada KARNATAKA
Dakshina Kannada
KARNATAKA
575004
India 
Phone  9890644115  
Fax    
Email  kurtkotiisha@gmail.com  
 
Source of Monetary or Material Support  
Manipal University 
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Department of Physiotherapy Kasturba Medical College Center for Basic Sciences Bejai Mangalore 575004 
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 
Isha Kurtkoti  KMC Hospitals, Mangalore  Dept of Physiotherapy, 2nd floor, KMC hospital, Ambedkar circle, Mangalore Dept of physiotherapy, 2nd floor, KMC Hospital, Attavar, Mangalore Dakshina Kannada KARNATAKA
Dakshina Kannada
KARNATAKA 		 9890644115

kurtkotiisha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee, Kasturba Medical College, Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Non specific Low Back Pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mulligan Bent Leg Raise  Position of patient: Supine lying with one pillow under the head and arms by the side of the body. Position of the therapist: Stride standing to the side of the leg which is to be treated. The flexed knee of the patient is placed over the shoulder of the therapist. Then the patient is asked to push the therapist away with his leg and relax. At that point the therapist pushes patient’s bent knee up as far as possible in the direction of his/her shoulder on the same side provided it did not cause pain. If it is painful the direction is altered by taking the leg more laterally. This technique is given for three repetitions of pain free 5 second isometric contractions of the hamstrings, performed in five progressively greater positions of hip flexion.  
Comparator Agent  Neural Sliding Technique  Position of patient: Supine lying with one pillow under the head and arms by the side of the body. Position of the therapist: The therapist stands facing the patient. The examiner lowers the hip flexion angle; below the P1 range for 5-10 degrees till the symptoms disappear. The ankle joint is then taken passively into plantar flexion within the available range as the manoeuvre to mobilize the sciatic nerve tract. Then the hip will be lowered and ankle will be dorsi flexed. This technique of nerve mobilization is done in 3 sets of 10 repetitions each with a gap of 10 seconds between each set.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  -Medically diagnosed mechanical low back pain patients with limited and/or painful SLR and/or with leg pain ---Age: 18 years and above.  
 
ExclusionCriteria 
Details  Any spinal surgery/infection/malignancy
Cauda equina syndrome, spondylolysis, spondylolisthesis, stenosis, radiculopathy
Pregnancy
Unstable medical conditions
Fractures of lower limb, spine 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Straight Leg Raise  Straight Leg Raise 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome measures chosen are pain, Roland Morris Disability Index and lumbar range of motion.   The secondary outcome measures chosen are pain, Roland Morris Disability Index and lumbar range of motion.  
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   01/08/2015 
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)  Open to Recruitment 
Publication Details   Trial yet to be started 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Patients who are diagnosed by consultants as low back pain will be approached. Written informed consent will be taken. Participants will be screened for inclusion and exclusion criteria. The patients will be assessed by a blinded observer. Patient will be then randomly assigned to receive any one of the two groups according to computer generated random table. Treatment will be given for 5 sessions over a period of one week. Outcome measures will be taken before and after the treatment course.
Group 1 will receive:
  Mulligan Bent Leg Raise technique
  Home exercise program

Group 2 will receive:
    Neurodynamic SLR  technique
     Home exercise program
 
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