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CTRI Number  CTRI/2025/02/081035 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 13/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   comparing the effects of contralateral and ipsilateral slider neural mobilization with blood flow restriction training in unilateral lumbar radiculopathy 
Scientific Title of Study   comparison of contralateral and ipsilateral slider neural mobilization with blood flow restriction training in unilateral lumbar radiculopathy- a randomized clinical 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  Somesh Rajesh Takkekar 
Designation  Post Graduate Student 
Affiliation   
Address  Room no 39 Advanced Physiotherapy Centre Sagar floor Dr Prabhakar Kore Hospital Belagavi Karnataka India 590010
KLE Institute of Physiotherapy Belagavi Karnataka India 590010
Belgaum
KARNATAKA
590010
India 
Phone  09420224591  
Fax    
Email  someshtakkekar1999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Peeyoosha Gurudut 
Designation  HOD and Professor 
Affiliation  KLE Institute of Physiotherapy 
Address  Room no 39 Advanced Physiotherapy Centre Sagar floor Dr Prabhakar Kore Hospital Belagavi Karnataka India 590010
KLE Institute of Physiotherapy Belagavi Karnataka India 590010
Belgaum
KARNATAKA
590010
India 
Phone  9844821355  
Fax    
Email  peeyooshagurudut@klekipt.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Peeyoosha Gurudut 
Designation  HOD and Professor 
Affiliation  KLE Institute of Physiotherapy 
Address  Room no 39 Advanced Physiotherapy Centre Sagar floor Dr Prabhakar Kore Hospital Belagavi Karnataka India 590010
KLE Institute of Physiotherapy Belagavi Karnataka India 590010
Belgaum
KARNATAKA
590010
India 
Phone  9844821355  
Fax    
Email  peeyooshagurudut@klekipt.edu.in  
 
Source of Monetary or Material Support  
KLE Institute of Physiotherapy Nehru Nagar Belagavi 590010 
 
Primary Sponsor  
Name  Somesh Rajesh Takkekar 
Address  Room no 39 Advanced Physiotherapy Centre Sagar floor Dr Prabhakar Kore Hospital Nehru Nagar Belagavi Karnataka India 590010  
Type of Sponsor  Other [Self] 
 
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 
Somesh Rajesh Takkekar  Tertiary Health Care Centre Belagavi  Room No 39 Advanced Physiotherapy Centre Sagar Ward Nehru Nagar Belagavi Karnataka India 590010
Belgaum
KARNATAKA 		 09420224591

someshtakkekar1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KAHER INSTITUTE OF PHYSIOTHERAPY RESEARCH AND ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparison of Contralateral and Ipsilateral slider neural mobilization with blood flow restriction training in unilateral lumbar radiculopathy  Comparison of Contralateral and Ipsilateral slider neural mobilization with blood flow restriction training in unilateral lumbar radiculopathy for one session 
Intervention  Contralateral and Ipsilateral Slider neural mobilization with blood flow restriction training and conventional treatment in unilateral lumbar radiculopathy  Contralateral and Ipsilateral Slider neural mobilization with blood flow restriction training and conventional treatment in unilateral lumbar radiculopathy for one session 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Participants:
All gender in the age group of 25-60 years.4
Diagnosed with subacute or chronic-stage low back pain with unilateral radiculopathy involving the sciatic nerve and its branches.
Pain intensity score of 3-7 on Numeric Pain Rating Scale (NPRS).
Hip range of motion below 120 o
Willing to participate and who can comprehend the commands.
 
 
ExclusionCriteria 
Details  Participants:
Extruded disc, inflammatory or other specific disorders of the spine such as ankylosing spondylitis, Paget’s disease, vertebral collapse, rheumatoid arthritis, spondylolisthesis, severe osteoporosis.1
Red flags for neural mobilization such as trauma, cancer, and infection and pregnant women, fractures of lower limb or spine within the past six months 4
Neurological deficits like stroke, SCI, PNI, myelopathy, multiple sclerosis.
Red flags for blood flow restriction training such as skin disorders like allergic
conditions, open wounds, active infection.
Musculoskeletal disorders, vascular disorder, cardiopulmonary disorders and psychological issues.
Features of vascular involvement like pallor, cyanosis, edema , lymphedema in lower limb.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Numeric pain rating scale (NPRS)
Modified Oswestry disability questionnaire (MODQ)
Goniometer
 		 Assess pain using Numeric pain rating scale (NPRS)
Assess functional disability using Modified Oswestry disability questionnaire (MODQ)
Assess hip range of motion during straight leg raise using Goniometer
 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/03/2025 
Date of Study Completion (India) 25/05/2025 
Date of First Enrollment (Global)  04/03/2025 
Date of Study Completion (Global) 25/05/2024 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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   COMPARISON OF CONTRALATERAL VERSUS IPSILATERAL SLIDER NEURAL MOBILISATION WITH BLOOD FLOW RESTRICTION TRAINING IN UNILATERAL LUMBAR RADICULOPATHY - A RANDOMISED CLINICAL TRIAL
AIM: To evaluate and compare the immediate effect contralateral versus ipsilateral neural slider mobilization with blood flow restriction training on lower extremity pain and hip range of motion (ROM) in unilateral lumbar radiculopathy.

•OBJECTIVE:
ØTo determine the immediate effect of contralateral neural slider mobilization with blood flow restriction training in unilateral lumbar radiculopathy.
ØTo determine the immediate effect of ipsilateral neural slider mobilization with blood flow restriction training in unilateral lumbar radiculopathy.
Hypothesis:
ØTo compare the immediate effect of contralateral versus ipsilateral neural slider mobilization with blood flow restriction training in lower extremity pain and ROM using NPRS, MODQ and universal goniometer in unilateral lumbar radiculopathy.
Null Hypothesis H0: There will be no difference in the effect of neural slider mobilization with blood flow restriction training on contralateral versus ipsilateral lower extremity pain and hip range of motion (ROM) in unilateral lumbar radiculopathy.

•Alternate Hypothesis H1: : There will be a difference in the effect of neural slider mobilization with blood flow restriction training on contralateral versus ipsilateral lower extremity pain and hip range of motion (ROM) in unilateral lumbar radiculopathy.
Research question:
What is the comparative effect of contralateral versus ipsilateral neural slider mobilization with blood flow restriction training on lower extremity pain and hip range of motion (ROM) in unilateral lumbar radiculopathy?
Inclusion criteria:
Participants:
ØAll gender in the age group of 25-60 years.4
ØDiagnosed with subacute or chronic-stage low back pain with unilateral radiculopathy involving the sciatic nerve and its branches.
ØPain intensity score of 3-7 on Numeric Pain Rating Scale (NPRS).
ØHip range of motion below 120 o
ØWilling to participate and who can comprehend the commands.
Exclusion criteria:

Participants:

ØExtruded disc, inflammatory or other specific disorders of the spine such as ankylosing spondylitis, Paget’s disease, vertebral collapse, rheumatoid arthritis, spondylolisthesis, severe osteoporosis.1
ØRed flags for neural mobilization such as trauma, cancer, and infection and pregnant women, fractures of lower limb or spine within the past six months 4
ØNeurological deficits like stroke, SCI, PNI, myelopathy, multiple sclerosis.
ØRed flags for blood flow restriction training such as skin disorders like allergic

   conditions, open wounds, active infection.

ØMusculoskeletal disorders, vascular disorder, cardiopulmonary disorders and psychological issues.
ØFeatures of vascular involvement like pallor, cyanosis, edema , lymphedema in lower limb.
Procedure:
•Prior to the commencement of the study, an ethical clearance will be obtained by Institutional Ethical Committee.
•The study will be registered under Clinical Trial Registry- India (CTRI). The intervention will begin once the CTRI registration number is obtained.
•Subject will be briefed about the purpose of the study
•All the subjects will be screened and then recruited as per the inclusion and exclusion criteria.
A written informed consent will be given to the participants in their own language and those consenting to participate in the study will be presented with the intervention.
•Brief demographic data will be obtained from each prior to the assessment.
 
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