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CTRI Number  CTRI/2025/02/080400 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On: 10/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   EFFECT OF BENT LEG RAISE TECHNIQUE FOR PAIN RELIEF AND IMPROVED FUNCTION IN PATIENTS WITH LOW BACK PAIN WITH RADICULOPATHY- A RANDOMIZED CONTROLLED TRIAL. 
Scientific Title of Study   EFFECT OF BENT LEG RAISE TECHNIQUE ON PAIN AND FUNCTIONAL DISABILITY AMONG PATIENTS WITH SPECIFIC LOW BACK PAIN WITH RADICULOPATHY – A RANDOMIZED CONTROLLED TRIAL. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vaishnavi Agrawal  
Designation  MPT student 
Affiliation  Dr. Ulhas Patil College Of Physiotherapy,Jalgaon. 
Address  NH 06, Gat No. 57 1, Khirdi Shivar, physiotherapy department, Tal and Dist. Jalgaon Jalgaon MAHARASHTRA 425001 India

Jalgaon
MAHARASHTRA
425001
India 
Phone  7972717026  
Fax    
Email  vaishnaviagrawal130@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jaywant Nagulkar 
Designation  Professor & Principal 
Affiliation  Dr. Ulhas Patil College Of Physiotherapy,Jalgaon. 
Address  NH 06, Gat No. 57 1, Khirdi Shivar, physiotherapy department, Tal and Dist. Jalgaon Jalgaon MAHARASHTRA 425001 India

Jalgaon
MAHARASHTRA
425001
India 
Phone  9822735329  
Fax    
Email  j4jaywant1981@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pradnya Mahajan 
Designation  Assistant Professor 
Affiliation  Dr. Ulhas Patil College Of Physiotherapy,Jalgaon. 
Address  NH 06, Gat No. 57 1, Khirdi Shivar, physiotherapy department, Tal and Dist. Jalgaon Jalgaon MAHARASHTRA 425001 India

Jalgaon
MAHARASHTRA
425001
India 
Phone  9284034348  
Fax    
Email  ppradz1816@gmail.com  
 
Source of Monetary or Material Support  
Dr. Ulhas Patil college of physiotherapy, Jalgaon NH 06, Gat No. 57 1, Khirdi Shivar, Tal And Dist Jalgaon 425001 
 
Primary Sponsor  
Name  Vaishnavi Agrawal 
Address  NH 06, Gat No. 57 1, Khirdi Shivar, Tal And Dist Jalgaon Jalgaon MAHARASHTRA 425001 India 
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 
Dr Vaishnavi Agrawal  Dr. Ulhas Patil College Of Physiotherapy  OPD no.207, Physiotherapy OPD, Jalgaon, MAHARASHTRA
Jalgaon
MAHARASHTRA 
7972717026

vaishnaviagrawal130@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of Dr. ulhas patil college of physiotherapy  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 
Intervention  Bent Leg Raise Technique  (7-10 sec hold /3 times / session with rest interval of 1 min) 5 times / week upto 1 week. 
Comparator Agent  Neural Tissue Mobilization and Mckenzie exercises.  Neural Tissue Mobilization- 2min(with1-min rest in between sets)upto 5 days Mckenzie exercises-10sec hold with 10reps upto 5 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1. All subjects with specific low back pain for a duration of more than 6 weeks. 2.Limitation of straight leg raise (SLR) angle between 30 to 70 degree due to pain. 3.All subjects with unilateral radiation of pain to posterior thigh and gluteal region (because of prolapsed disc). 4.Both male & female subjects. 5.Body mass index between (BMI) 18.5-25kg/m2 6.Numerical pain rating scale (NPRS) 3 to 6 out of 10 7.Oswestry Disability Index (ODI) score mild and moderate disability i.e., 20-40. 8.Subjects willing to participate for 5 sessions treatment. 
 
ExclusionCriteria 
Details  1.History of spinal surgery in recent /previous six months. 2.History of lower limb trauma in recent or previous six months 3.Subjects with psychological low back pain & non-specific low back pain. 4.Congenital deformities of spine & lower limb. 5.Deep tendon reflex altered or diminished. 6.Tumour or malignancies. 7.Any other major illness or unstable cardiac condition. 8.Numerical Pain Rating Scale (NPRS) seven or more than seven out of 10 . 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Numerical Pain Rating Scale (NPRS)  Pre and Post intervention (after 1 week of intervention) 
 
Secondary Outcome  
Outcome  TimePoints 
Oswestry Disability Index (ODI)  Pre & Post intervention (after 1 week of intervention) 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   20/03/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
AIM- Effect of Bent Leg Raise Technique on Pain & Functional Disability Among Patients with Specific Low Back Pain with Radiculopathy.

OBJECTIVE- 1. To find out effect of bent leg raise technique on pain among patients with specific low back pain with radiculopathy. 2. To find out effect of bent leg raise technique on functional disability among patients with specific low back pain with radiculopathy.

PROCEDURE- Ethical clearance will be obtained from institutional ethical committee. Patients will be screened according to clinical inclusion and exclusion criteria. Informed consent form will be taken from the subjects. The purpose and procedure will be explained to patients selected for the study. The selected patients will be randomly allocated into 2 groups experimental and control group by using randomized computer-generated sequence method. Physiotherapist & patients will be blinded to allocation.  Allocation concealment will be done using envelop method. The pre-test outcome measures will be recorded. And the treatments will proceed till 1 week. After 1 weeks the outcome measures will be assessed, and the data will be interpretated by statistical analysis tests. The result data will be represented in tabular formats. CONSORT guidelines will be followed in study.

INTERVENTION PROTOCOL-
EXPERIMENTAL GROUP - Bent Leg Raise Technique 

 Patient’s position: The patient will be positioned in a supine lying position with the affected knee rested on the therapist shoulder so as hip and knee were bent at 90 and 90 degrees.
Therapist’s position: The therapist will be standing beside the side to be treated facing the patient. 
Hand placement: The therapist hand will place on the lower end of femur bone of the affected side.
Technique: The patient’s flexed knee will place over the therapist’s shoulder while the popliteal fossa of the affected knee rested on the therapist shoulder.  Then the patient will ask to push the therapist shoulder with his leg then voluntary relax. At this point of relaxation, the therapist pushed the bent knee up as far as possible in the direction of the shoulder on the same side of the affected leg without making the patient feel pain. This stretch maneuver will be sustained for 5-10 seconds and then relaxed if the pain or restriction eased; the hip will take into further flexion. It will be ensured that there was no pain during the procedure. If the patient will felt pain the direction of the leg raise will alter by medial rotating or abducting the hip. The contra lateral leg will keep relaxed and allowed to move as it goes. At the end of the range, the position will hold for 10 seconds, and limb brought back to neutral position.
Dosage – (7-10 sec hold /3 times / session with rest interval of 1 min) 5 times / week up to 1 week.


CONTROL GROUP - Control Group will receive conventional physiotherapy i.e., Neural tissue mobilization and Mckenzie exercises. 
1. Neural tissue Mobilization (NTM) -   Patient Position: Patient lies supine on the plinth.
Therapist position: The therapist passively raises the patient’s leg into a SLR until the initial onset of pain. Hip is then flexed and extended in a small range of motion.
Duration: 2 min (with 1 minute rest in-between sets                     Repetition: 3 sets.

2. Spinal Extension Exercise (Mckenzie Exercise)-    Spinal Extension Exercise (Mckenzie exercise) were taught to the patient and to do 5 days with 10 seconds hold and for10 repetitions.
1. Prone position lying flat (patient lies flat on their stomach) 2. Prone position propped on elbows (patient lies flat on their stomach and props themselves onto their elbows with the spine in extension). 3. Prone position propped on hands (patient lies flat on their stomach and props themselves onto their hands with elbows in full extension, with the spine in extension). 4. Standing lumbar extension (patient stands upright with feet shoulder-width apart and puts hands on the lower back while extending the spine). 5. Sustained Extension- Patient lies prone with the table positioned in extension, creating a gradual and sustained extension stress to the lumbar spine. Gradually lift the table up into more extension Use this for patients – kyphotic deformity - Major derangements.
 
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