| 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
|
|
|
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
|
|
|
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. |