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CTRI Number  CTRI/2024/06/069366 [Registered on: 21/06/2024] Trial Registered Prospectively
Last Modified On: 21/06/2024
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   Effects Of Spinal Decompression Therapy Versus Mckenzie Exercise in lumbar radiculopathy  
Scientific Title of Study   Effects Of Prone Spinal Decompression Therapy In Addition To Mckenzie Exercises Versus Mckenzie Exercise Only On Pain And Functional Disability In Lumbar Radiculopathy- A Randomised 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  Rachana 
Designation  Master of Physiotherapy student 
Affiliation  Institute of Physiotherapy, Srinivas university  
Address  Department of Physiotherapy Institute of Physiotherapy, Srinivas university,pandeshwar campus Mangaluru

Dakshina Kannada
KARNATAKA
575001
India 
Phone  7349142382  
Fax    
Email  rachanaps1999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Madhuripu P 
Designation  Associate professor  
Affiliation  Institute of Physiotherapy, Srinivas university  
Address  Department of Physiotherapy Institute of Physiotherapy, Srinivas university,pandeshwar campus Mangaluru


KARNATAKA
575001
India 
Phone  9446292852  
Fax    
Email  madhuripu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rachana 
Designation  Master of Physiotherapy student 
Affiliation  Institute of Physiotherapy, Srinivas university  
Address  Departmemt of Physiotherapy Institute of Physiotherapy, Srinivas university,pandeshwar campus Mangaluru karnataka


KARNATAKA
575001
India 
Phone  7349142382  
Fax    
Email  rachanaps1999@gmail.com  
 
Source of Monetary or Material Support  
MSD opd, Institute of Physiotherapy, Srinivas university, pandeshwar campus, Mangalore, Dakshina kannada district ,Karnataka 575001 
Nil 
 
Primary Sponsor  
Name  Rachana  
Address  Department of Physiotherapy Institute of Physiotherapy Srinivas university Mangaluru Srinivas hospital  
Type of Sponsor  Other [] 
 
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 
Rachana   Srinivas Institute of medical science, hospital   Department of Physiotherapy Institute of Physiotherapy Srinivas university pandeshwar campus, Mangaluru.
Dakshina Kannada
KARNATAKA 		 7349142382

rachanaps1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Srinivas university ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M488||Other specified spondylopathies,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Mckenzie exercise only   Mckenzie exercise Prone on elbow Prone full extension Back extension standing for 3 days per week for 4 week  
Intervention  Spinal decompression therapy and mckenzie exercise   Spinal decompression traction unit and mckenzie exercise given for 3 days per week for 4 week  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Referred by the Orthopaedician
Male and female aged between 25 to 55.
LBP with unilateral radiating pain for at least 3 weeks.
Positive Straight leg raise test at hip flexion 30- 70 degree
Positive Slump test
Patients with MRI and x ray on availability.
Experience of centralization of symptoms during repeated movements .
VAS score 4 or more
Sensory abnormalities
Motor weakness
 
 
ExclusionCriteria 
Details  On medications (NSAIDS, Corticosteroids).
Red flags: Cancer, Inflammation or any infection, need for urgent surgery due to cauda equina syndrome or worsening weakness.
Past surgical history on LS, hip or pelvis.
Deformities in spine
Ankylosing spondylitis Spondylolisthesis
Multiple level disc herniation and degeneration
Pregnancy
Vascular, pulmonary or coronary artery disease.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
VAS
Roland morris disability questionnaire  		 Pre intervention 1st day
4th week
12th week 
 
Secondary Outcome  
Outcome  TimePoints 
Tampa scale of kinesiophobia
SF 36 questionnaire
Global rating fo change  		 Pre intervention
4th week
12th week  
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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 2/ Phase 3 
Date of First Enrollment (India)   10/07/2024 
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="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   Single blinded randomised clinical trial, recruiting 44 participants diagnosed with lumbar radiculopathy. Held within period of 1 year .we will be giving intervention for 2 group. 1st group mckenzie exercises and Spinak decompression therapy and mckenzie exercise and for 2nd group only mckenzie exercises. With a follow up at 4th week and 12th week 
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