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Clinical Trial Details (PDF Generation Date :- Wed, 29 Sep 2021 07:28:37 GMT)

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 Comparison of Mulligans Bent Leg Raise Technique and Neural Sliding Technique on Straight Leg Study Raise in Non- Specific Low Back Pain patients: A Randomized Clinical Trial. Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Isha M Kurtkoti Trial Coordinator (multi-center study) Designation Student Affiliation Kasturba Medical College Address Department of Physiotherapy Kasturba Medical College Centre for Basic Sciences Bejai Department of Physiotherapy Light house Hill road Hampankatta Mangalore Dakshina Department of Physiotherapy Kasturba Medical College Centre for Basic Sciences Bejai Mangalore Department of Physiotherapy Light house Hill road Hampankatta Mangalore KARNATAKA Dakshina Kannada KARNATAKA 575004 India Phone 9890644115 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Charu Eapen Query) 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 [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Isha M Kurtkoti

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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 [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Manipal University Primary Sponsor Primary Sponsor Details 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 Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Isha Kurtkoti KMC Hospitals, Dept of Physiotherapy, 9890644115 Mangalore 2nd floor, KMC hospital, Ambedkar circle, [email protected] Mangalore Dept of physiotherapy, 2nd floor, KMC Hospital, Attavar, Mangalore Dakshina Kannada KARNATAKA Dakshina Kannada KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Instituitional Ethics Approved 26/11/2014 No Committee, Kasturba Medical College, Mangalore Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Non specific Low Back Pain Intervention / Type Name Details Comparator Agent

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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 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. Exclusion Criteria Exclusion Criteria 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 Computer generated randomization

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Random Sequence Method of Sequentially numbered, sealed, opaque envelopes Concealment 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 The secondary outcome measures chosen are pain, Roland Morris Disability Index and lumbar pain, Roland Morris Disability Index and lumbar range of motion. 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 01/08/2015 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Open to Recruitment Trial (India) Publication Details Trial yet to be started 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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