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CTRI Number  CTRI/2024/11/076804 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 25/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   42 participants with low back pain with radiculopathy are divided into 3 group 1st group received conventional physical therapy,2nd group received conventional physical therapy and sciatic nerve mobilization and 3rd group received conventional physical therapy and muligen bent leg raise technique. 
Scientific Title of Study   A study to find the effect of sciatic nerve mobilization and mulligan bent leg raise technique along with conventional physical therapy on pain, range of motion and functional status in patients with radiating low back pain: An experimental study 
Trial Acronym  LBP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohit Dangar  
Designation  PG Physiotherapy student  
Affiliation  GOVERNMENT PHYSIOTHERAPY COLLEGE,JAMNAGAR 
Address  Exercise therapy department OPD, government Physiotherapy college,jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  7575042430  
Fax    
Email  dangar.mohit2001@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dinesh Sorani  
Designation  Principal of government Physiotherapy college  
Affiliation  GOVERNMENT PHYSIOTHERAPY COLLEGE,JAMNAGAR 
Address  Room number 1,Exercise therapy department,Government Physiotherapy college, jamnagar India


GUJARAT
361008
India 
Phone  7575042430  
Fax    
Email  soranidinesh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mohit Dangar  
Designation  PG Physiotherapy student  
Affiliation  GOVERNMENT PHYSIOTHERAPY COLLEGE,JAMNAGAR 
Address  Exercise therapy department, Government Physiotherapy college, jamnagar


GUJARAT
361008
India 
Phone  7575042430  
Fax    
Email  dangar.mohit2001@gmail.com  
 
Source of Monetary or Material Support  
Government Physiotherapy College,Jamnagar,India - 361008 
 
Primary Sponsor  
Name  Government Physiotherapy college jamnagar  
Address  Exercise therapy department, government Physiotherapy college,jamnagar, GUJRAT ,india - 361008 
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 
Dr Mohit Dangar  Government Physiotherapy College - jamnagar  Exercise therapy department,Government physiotherapy college,Jamnagar GUJRAT INDIA -361008
Jamnagar
GUJARAT 		 7575042430

dangar.mohit2001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee shree M.P. Shah Govt. Medical college and G. G. Govt. Hospital, Jamnagar   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M999||Biomechanical lesion, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Conventional Physical therapy for low back pain   Isometric back exercise, isometric abdominal exercise, draw in maneuver, spinal mobility exercise, stretching, traction, IFT for 5 sessions/ week for 4 weeks. 
Comparator Agent  Conventional Physical therapy+Mulligan bent leg raise technique   Isometric back exercise, isometric abdominal exercise, draw in maneuver, spinal mobility exercise, stretching, traction, IFT, Mulligan bent leg raise technique for 5 sessions/ week for 4 weeks. 
Comparator Agent  Conventional Physical therapy+sciatic nerve mobilization   Isometric back exercise, isometric abdominal exercise, draw in maneuver, spinal mobility exercise, stretching, traction, IFT, sciatic nerve mobilization for 5 sessions/ week for 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects willing to participate in the study,
Both male and female are included,
Diagnosed patients with radiating LBP having age 18 to 60 years,
SLR test range less than 70 degree.
 
 
ExclusionCriteria 
Details  Spinal fracture or major trauma,
Acute disc bulge,
Lumbar instability,
Sensory and motor deficits related to other neurological conditions,
Articular pathology,
Rheumatoid arthritis,
Other systemic diseases 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual analogue scale(VAS), Stright leg raise range of motion (SLR ROM), Oswastry disability index (ODI)  Baseline(on 1st day) and after 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Oswastry disability index (ODI)  Baseline(on 1st day) and after 4 weeks 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   01/01/2025 
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="8"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dangar.mohit2001@gmail.com].

  6. For how long will this data be available start date provided 01-02-2025 and end date provided 01-02-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Data will be collecting from the patients coming to Government Physiotherapy College-OPD, Jamnagar. From this data I will extract the number of patients which are coming for the treatment of Low Back Pain (LBP). Patients who fit selection criteria will be selected. Consent will be taken from patients and Patients with LBP will be treated with either mulligan bent leg raise technique or sciatic nerve mobilization along with conventional physical therapy for 4 weeks.Before and after intervention SLR test range,ODI and VAS will be measured. 
Data will be collected over a period of 8 months.

 
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