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CTRI Number  CTRI/2024/04/065135 [Registered on: 03/04/2024] Trial Registered Prospectively
Last Modified On: 11/04/2024
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   The effect of Nerve Mobilisation on Nerve Signals Testing in Lumbar Radiculopathy Patients 
Scientific Title of Study   To compare the effect of Sliders vs Tensioners on Nerve Conduction Studies in Lumbar Radiculopathy Patients 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nitya Chophla 
Designation  Research Scholar, MPT 
Affiliation  Manav Rachna International Institute Research & Studies 
Address  QG07 Department of Physiotherapy School of Allied Health Sciences Manav Rachna International Institute Research & Studies Sector – 43, Delhi–Surajkund Road Faridabad – 121004 Haryana, India

Faridabad
HARYANA
121004
India 
Phone  9910030325  
Fax    
Email  chophlanitya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Divya Aggarwal 
Designation  Assistant Professor 
Affiliation  Manav Rachna International Institute Research & Studies 
Address  QT 05 Department of Physiotherapy School of Allied Health Sciences Manav Rachna International Institute Research & Studies Sector – 43, Delhi–Surajkund Road Faridabad – 121004 Haryana, India

Faridabad
HARYANA
121004
India 
Phone  9999597755  
Fax    
Email  divyaaggarwal.sahs@mriu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Divya Aggarwal 
Designation  Assistant Professor 
Affiliation  Manav Rachna International Institute Research & Studies 
Address  QT 05 Department of Physiotherapy School of Allied Health Sciences Manav Rachna International Institute Research & Studies Sector – 43, Delhi–Surajkund Road Faridabad – 121004 Haryana, India

Faridabad
HARYANA
121004
India 
Phone  9999597755  
Fax    
Email  divyaaggarwal.sahs@mriu.edu.in  
 
Source of Monetary or Material Support  
Q Block Department of Physiotherapy, SAHS, Manav Rachna International Institute of Research and Studies Sector – 43, Delhi–Surajkund Road Faridabad – 121004 Haryana, India 
 
Primary Sponsor  
Name  none 
Address  none 
Type of Sponsor  Other [none] 
 
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 Divya Aggarwal  Physiotherapy Department OPD & Neurology Lab   Q Block Department of Physiotherapy, MRIIRS, Room No: QG 07, QG 08
Faridabad
HARYANA 		 9910030325

chophlanitya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee at School of Allied Health Sciences, Manav Rachna International Institute of Research & Studies, Faridabad, Haryana  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G541||Lumbosacral plexus disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  Patient will be given stretching for specific muscle groups with hot pack and core strengthening exercises for 4 weeks, 3 days a week. 
Intervention  Sliders Neurodynamic Mobilisation  Patient will be given sliders neural mobilisation with hot pack and core strengthening exercises for 4 weeks, 3 days a week. 
Intervention  Tensioners Neurodynamic Mobilisation  Patient will be given tensioners neural mobilisation with hot pack and core strengthening exercises for 4 weeks, 3 days a week. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  49.00 Year(s)
Gender  Both 
Details  1. Diagnosed cases of Lumbar Radiculopathy with Clinical Symptoms
2. NPRS Score between 4/10 to 8/10
3. Chronic Cases more than/ equal to 3 months
4. able to comprehend English language 
 
ExclusionCriteria 
Details  1. Patients with diabetic neuropathy
radiculopathy due to other pathology: tumour, instability
2. chemical dependence/ alcohol abuse
3. any vertebral fracture/ spinal surgery in past 2 years
4. history of systemic disorder 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Electrical Response of Nerve using
- H reflex latency of Tibial Nerve
- F wave latency of Tibial Nerve
- F wave latency of Common Peroneal Nerve 		 base line assessment

re assessment after 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
- NPRS Score
- Modified ODI Score 		 base line assessment

re assessment after 4 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   12/04/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 aim of the study is to compare the effect of Sliders and Tensioners neurodynamic mobilization on the parameters of Nerve Conduction Studies (NCS) in lumbar radiculopathy patients.

Patients will be recruited from Physiotherapy Outpatient Department of Manav Rachna University. A study sample of 30 participants will be selected on the basis of inclusion & exclusion criteria. The subjects will be randomly divided into three groups: Group A- Sliders group, Group B- Tensioners group & Group C- Control Group. A written informed consent will be taken from the participants after explaining them the treatment protocol, associated risks & benefits Outcome measures will be measured at baseline and after termination of 4 weeks and will be compared.

 
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