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CTRI Number  CTRI/2023/09/057580 [Registered on: 13/09/2023] Trial Registered Prospectively
Last Modified On: 06/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   In our study we will be including patients who are experiencing pain, tingling, numbness in posterior aspect till the foot. We will be giving neural sliding intervention to see its effect on pain, disability, balance and fear and its short term effect. 
Scientific Title of Study   Effect of neural tissue mobilization on pain, disability, balance and fear avoidance in patients with lumbar 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  Dr Neha Baheti 
Designation  MPT Resident 
Affiliation  MGM Institute of Physiotherapy 
Address  Department of Musculoskeletal Physiotherapy, MGM Institute of Physiotherapy, N-6,Cidco, Aurangabad

Aurangabad
MAHARASHTRA
431001
India 
Phone  7387379920  
Fax    
Email  nehasbaheti7387@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kapil Garg 
Designation  Associate Professor, Department of Musculoskeletal Physiotherapy 
Affiliation  MGM Institute of Physiotherapy 
Address  Department of Musculoskeletal Physiotherapy, MGM Institute of Physiotherapy, N-6,Cidco, Aurangabad

Aurangabad
MAHARASHTRA
431001
India 
Phone  9027612715  
Fax    
Email  kapilgarg@mgmiop.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Neha Baheti  
Designation  MPT Resident 
Affiliation  MGM Institute of Physiotherapy 
Address  Department of Musculoskeletal Physiotherapy, MGM Institute of Physiotherapy, N-6,Cidco, Aurangabad

Aurangabad
MAHARASHTRA
431001
India 
Phone  7387379920  
Fax    
Email  nehasbaheti7387@gmail.com  
 
Source of Monetary or Material Support  
MGM Institute of Physiotherapy, N-6,Cidco, Aurangabad 
 
Primary Sponsor  
Name  MGM Institute of Physiotherapy, Aurangabad 
Address  MGM Institute of Physiotherapy, N-6,Cidco, Aurangabad 
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 Neha Baheti  Musculoskeletal OPD, MGM Physiotherapy and Rehabilitation Centre  C Building, MGM Physiotherapy and Rehabilitation Centre, N-6,Cidco, Aurangabad
Aurangabad
MAHARASHTRA 		 7387379920

nehasbaheti7387@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGM Institute of Physiotherapy Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy  1.Moist pack 2. Stretching- Piriformis,Hamstring,Calf 3.Strengthening-Drawing in maneuver,Posterior pelvic tilt,Back extensor strengthe-ning,Bridging,Prone SLR- for 3 days in a week for 2 weeks 
Intervention  Neural Tissue mobilization  Sliders for sciatic nerve- 4 sets of 10 reps- for 3 days in a week for 2 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1) Participants with age group between 18-50 year of both genders.
2) Patients with low back pain lasting more than 3 months and radiating to posterior aspect of thigh and below the knee joint.
3) Pain on VAS score2-7
4) Able to understand and read the basic local language(Hindi)
 
 
ExclusionCriteria 
Details  1) Any trauma or fracture of lumbar spine and lower limb within last 1 year.
2) Patients having spinal deformities
3) Spondylolisthesis and lumbar canal stenosis patients
4) Patients with BMI > 30kg/m2
5) Patients with any systemic disease
6) Pregnancy
 
 
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 
Oswestry Disability Index  baseline and after 2 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
1. Visual Analogue Scale
2. Star Excursion Balance Test
3. Fear Avoidance Belief Questionnaire 		 Baseline
At 2 weeks 
 
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   Phase 3 
Date of First Enrollment (India)   16/09/2023 
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 Yet Recruiting 
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   The prevalence of lumbosacral radiculopathy (LR) is roughly 3–5%; however, the association of adjacent lumbosacral nerve roots producing neural dysfunction and pain is more resistant to conservative treatment than LBP alone. It has been postulated that, if nervous system is irritated, the system may present with neural edema, ischemia and fibrosis, leading to further damage resulting in pain and decreased function. Neural tissue mobilization has been proven to reduce pain, disability in patient’s lumbar radiculopathy. There is absence of  enough evidence weather neural tissue mobilization is effective in improving balance and fear avoidance in lumbar radiculopathy patients. The exercise program will be followed by the individuals for 2 weeks, thrice a week. We will be assessing the outcome at baseline and after 2 weeks. Mean and SD will be calculated for quantitative variables like pain, disability, fear avoidance and balance. Data will be represented in form of visual impression like bar- diagram etc.Two sample t-test will be used to compare between group difference. Paired t-test will be used to compare within group difference.P value of < 0.05 will be considered statistically significant. 
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