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CTRI Number  CTRI/2019/02/017840 [Registered on: 27/02/2019] Trial Registered Prospectively
Last Modified On: 22/02/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A study to compare the individual and combined effect of nerve flossing technique and intermittent lumbar traction on Pain and disability in lumbar radiculopathy patients. 
Scientific Title of Study   A study to compare the individual and combined effect of nerve flossing technique and intermittent lumbar traction on P1 and P2 angle of SLR,Pain and disability in lumbar radiculopathy patients-a comparative study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Riddhi shah 
Designation  1st year M.P.T. Resident 
Affiliation  Government physiotherapy college,Jamnagar 
Address  Exercise and electrotherapy department of Government physiotherapy college,In old T.B. hospital, Rameshwarnagar, Jamnagar
Exercise and electrotherapy department of Government physiotherapy college,In old T.B. hospital, Rameshwarnagar, Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  8511550551  
Fax    
Email  riddhishah1605@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Karishma jagad 
Designation  Senior lecturer  
Affiliation  Government physiotherapy college,Jamnagar 
Address  Government physiotherapy college,In old T.B. hospital, Rameshwarnagar, Jamnagar
Government physiotherapy college,In old T.B. hospital, Rameshwarnagar, Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9374141991  
Fax    
Email  Karishmadodia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Riddhi shah 
Designation  1st year M.P.T. Resident 
Affiliation  Government physiotherapy college,Jamnagar 
Address  Exercise and electrotherapy department of Government physiotherapy college,In old T.B. hospital, Rameshwarnagar, Jamnagar
Exercise and electrotherapy department of Government physiotherapy college,In old T.B. hospital, Rameshwarnagar, Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  8511550551  
Fax    
Email  riddhishah1605@gmail.com  
 
Source of Monetary or Material Support  
Government physiotherapy college,Jamnagar 
 
Primary Sponsor  
Name  Government physiotherapy collegeJamnagar 
Address  Government physiotherapy college,In old T.B. hospital, Rameshwarnagar, Jamnagar 
Type of Sponsor  Research institution and hospital 
 
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 
Riddhi Shah  Government physiotherapy college,Jamnagar  1.P1 and P2 angle of SLR 2.Modified Oswestry Disability Index
Jamnagar
GUJARAT 
8511550551

riddhishah1605@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
M.P.Shah govt. medical college and Guru Gobindsingh Hospital Jamnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G570||Lesion of sciatic nerve,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Intermittent lumbar traction 2. Nerve flossing technique  1. Intermittent lumbar traction is a modality which provides distraction force between two vertebrae and unload the spinal structures. 2. Nerve flossing,a type of neural mobilization,is an active non-invasive healing procedure  
Comparator Agent  1.Visual analogue scale 2.P1 and P2 angle of SLR 3.Oswestry Disability Index   1.It is a pain rating scale. 2.SLR neurodynamic test results in hip flexion range of motion and symptom intensity. 3.it is commonly used back functional scale. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Involvement of l4,l5,S1,S2 nerve root pain radiating to one or both legs.
2.Patients with positive SLR and SLUMP test.
3.Patients with acute or sub-acute stage duration of symptoms < 12 weeks.
4.All subjects with Oswestry disability index score >20%  
 
ExclusionCriteria 
Details  1.Any spinal conditions in which movement are contraindicated
2.Acute sprain,strain and inflammation or any painful symptoms aggravated by treatment
3.Rheumatoid arthritis
4.Tumours or infections like TB of spine
5.Malignancy
6.Pregnancy
7.Uncontrolled Hypertension
8.Patients with congenital deformity
9.Non cooperative patients
10.Participants with cervical spine pathology 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Visual analogue scale
 
After 5 days and at the end of 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.P1 and P2 angle of SLR
2.Modified Oswestry Disability Index 
After 5 days and 2 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)   15/03/2019 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet done 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Lumbar radiculopathy (often known as Sciatica) refers to the symptoms of pain, tingling, numbness or weakness that travel down the low back and into the leg or extremity.

The use of lumbar traction is to unload the spinal structures by using the vertebral seperation. The nerve flossing technique is a neural mobilization technique which actually moves the nerve through the tissues from both ends which leads to less nerve excursion. the following interventions individually and also their comparision and finding the best method for treatment.
 
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