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CTRI Number  CTRI/2014/09/004950 [Registered on: 01/09/2014] Trial Registered Prospectively
Last Modified On: 11/07/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to see relationship between lower spine movement with legpain and back pain in lumbar disc prolapse patients 
Scientific Title of Study   A prospective,cross sectional study to find out correlation between supine lying low back pain/leg pain and retrolisthesis in Lumbar disc prolapse patient 
Trial Acronym  No 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bharat R Dave 
Designation  Director Consultant Spine Surgeon Institutional Head 
Affiliation  Stavya Spine Hospital and Research Institute 
Address  Stavya Spine Hospital and Research Institute Nr Nagari Hospital Nr Hindi Rashtrabhasha College Mithakhali Ellisbridge Ahmedabad
NA
Ahmadabad
GUJARAT
380006
India 
Phone  07926568174  
Fax  07926408174  
Email  brd_172@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ajay Krishnan 
Designation  Consultant Spine Surgeon Co investigator 
Affiliation  Stavya Spine Hospital and Research Institute 
Address  Stavya Spine Hospital and Research Institute Nr Nagari Hospital Nr Hindi Rashtrabhasha College Mithakhali Ellisbridge Ahmedabad
NA
Ahmadabad
GUJARAT
380006
India 
Phone  07926565657  
Fax  07926408174  
Email  drajaykrishnan@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Shaunak C Dudhia 
Designation  Consultant Physician and Cardiologist 
Affiliation  Stavya Spine Hospital and Research Institute 
Address  Stavya Spine Hospital and Research Institute Nr Nagari Hospital Nr Hindi Rashtrabhasha College Mithakhali Ellisbridge Ahmedabad
Dudhia Medical and Children Hospital Khadia Ahmedabad Gujarat
Ahmadabad
GUJARAT
380006
India 
Phone  07926565757  
Fax  07926408174  
Email  drscdudhia@gmail.com  
 
Source of Monetary or Material Support  
Non Funded  
 
Primary Sponsor  
Name  Stavya Spine Hospital and Research Institute 
Address  Stavya Spine Hospital and Research Institute Nr Nagari Hospital Nr Hindi Rashtrabhasha College Mithakhali Ellisbridge Ahmedabad 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Stavya Spine Hospital and Research Institute  Nr Nagari Hospital Nr Hindi Rashtrabhasha College Mithakhali Ellisbridge Ahmedabad 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bharat R Dave  Stavya Spine Hospital and Research Institute  Spine Research Wing Nr Nagari Hospital Nr Hindi Rashtrabhasha College Mithakhali Ellisbridge Ahmedabad
Ahmadabad
GUJARAT 		 07926568174
07926408174
brd_172@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Stavya Spine Hospital and Research Institute Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Lumbar Disc Diseases ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients are included in the study if all of the following criteria are met:

1.Patients having single level disc disease (L4/5 or L5 S1): Degenerative/ Disc prolapse
2.Patients having Supine lying pain (LBP/ leg pain/ discomfort/ numbness).
3.Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;
4.Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study.
5.Male or Female,having age between 35-70 yrs
 
 
ExclusionCriteria 
Details  Patients are excluded from participating in this study if any of the following criteria are met:

1.Has had previous surgery at the index level;
2.Has a fused level adjacent to the index level;
3.Patients with Diffused Idiopathic Skeletal Hyperostosis (DISH);
4.Active systemic or local infection;
5.Known or documented history of communicable disease, including AIDS or HIV;
6.Active hepatitis (receiving medical treatment within two years);
7.Active rheumatoid arthritis, non-controlled diabetes mellitus.
8.Immunologically suppressed, history of Paget’s disease, osteomalacia, or any other metabolic bone disease;
9.Morbid obesity defined as a body mass index > 40 kg/m2 or weight more than 100 pounds over ideal body weight;
10.Active malignancy. A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy for more than 5 years;
11.Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol);
12.Pregnant or planning to become pregnant during study period;
13.Patients who are incarcerated.
14.Patients who have limited life expectancy due to significant medical comorbidities.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Association of supine lying low back pain/leg pain with retrolisthesis  1st Day Assessment 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/09/2014 
Date of Study Completion (India) 03/11/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a single centre,prospective,observational study. Patients will be evaluated in single OPD visit over time to obtain target 200 number of patients.
A total minimum of two hundred (200) patients who meet the inclusion/exclusion criteria will be enrolled in the study.
Patients will be evaluated clinically and using X-ray radiographs, MRI in supine lying position.
The total duration of this study is expected to be upto six to twelve ( 6 - 12 ) months.
 
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