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CTRI Number  CTRI/2019/12/022221 [Registered on: 03/12/2019] Trial Registered Prospectively
Last Modified On: 26/11/2019
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   Evaluating the effect of one type of Physiotherapy treatment,in patients with Low Back Pain. 
Scientific Title of Study   Efficacy of Neurodynamic Techniques in the treatment of Low Back Pain 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Binay Kumar Pandey 
Designation  PhD (Neurophysiology) Scholar 
Affiliation  Indira Gandhi Institute of Medical Science, Patna  
Address  Department of Neurology,Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna

Patna
BIHAR
800014
India 
Phone    
Fax    
Email  physiobinaypandey@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Kumar 
Designation  Professor & Head, Chief Guide 
Affiliation  Indira Gandhi Institute of Medical Science, Patna  
Address  Department of Neurology,Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna

Patna
BIHAR
800014
India 
Phone    
Fax    
Email  kumardrashok_1@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Binay Kumar Pandey 
Designation  PhD (Neurophysiology) Scholar 
Affiliation  Indira Gandhi Institute of Medical Science, Patna  
Address  Department of Neurology,Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna

Patna
BIHAR
800014
India 
Phone    
Fax    
Email  physiobinaypandey@hotmail.com  
 
Source of Monetary or Material Support  
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES Sheikhpura,PATNA BIHAR- 800014 INDIA 
 
Primary Sponsor  
Name  INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES PATNA BIHAR INDIA 
Address  Department of Neurology, IGIMS, Sheikhpura Patna Bihar 800014 
Type of Sponsor  Government 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 
Binay Kumar Pandey  INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES PATNA BIHAR INDIA  Department of Neurology,Sheikhpura, Patna- 800014
Patna
BIHAR 		 9334408377

physiobinaypandey@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, IGIMS, Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M545||Low back pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Therapy  Self exercises for Low Back Pain 
Intervention  Neurodynamic Technique Slump  a movement-based intervention aimed at restoring the homeostasis in and around the nervous system by mobilization of the nervous system itself or the structures that surround the nervous system 
Intervention  Neurodynamic Techniques,SLR  a movement-based intervention aimed at restoring the homeostasis in and around the nervous system by mobilization of the nervous system itself or the structures that surround the nervous system 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1 Patients with Low Back Pain symptoms that referred to buttocks as well as distal to the buttocks,
2 Reproduction of the patient’s symptoms with slump testing, no change in symptoms with lumbar flexion or extension
 
 
ExclusionCriteria 
Details  1 Patients with ‘‘red flags’’ for a serious spinal condition (e.g. infection, tumors, osteoporosis, spinal fracture, etc.)
2 Individuals who were pregnant, has a history of spinal surgery,
3 Positive neurologic signs or symptoms suggestive of nerve root involvement (diminished upper or lower extremity reflexes, sensation to sharp and dull, or strength),
4 Osteoporosis,
5 A straight leg raise (SLR) testof less than
45 degree
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Change in Pain using NPRS
(Numeric Pain Rating Scale)
2. Change in Disability assessed using Modified Oswestry Disability Index (ODI)
3.Change in nerve conduction studies : Motor conduction of the tibial nerve and peroneal nerve; Sensory conduction of the sural nerve; H-reflex, H:M ratio (Soleus muscle)
 		 3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse outcome if any  3 weeks 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   23/12/2019 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The purpose of this study is to verify, through a randomized controlled trial, the effectiveness of a three-week program of neurodynamic techniques on pain, disability and changes in NCS, H-Reflex, H:M ratio in individuals with low back pain.

First aim is to investigate the effect of two Neurodynamic techniques on pain and disability in patients with LBP. The two techniques tested in this study are “Slump” Neurodynamic Technique and “Straight Leg Raise” Neurodynamic Technique.

Second aim is to determine whether this type of physiotherapy treatment (neurodynamic techniques)  for individuals with low back pain can bring some neurophysiological changes in the nerves which can be quantified in the electrophysiological studies like NCS, H-reflex and H;M ratio, compared to conventional physical therapy treatment.


 
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