FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/04/085929 [Registered on: 29/04/2025] Trial Registered Prospectively
Last Modified On: 28/04/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Improving Diagnosis of Neck Spine and Nerve Conditions Using X-rays and MRI. 
Scientific Title of Study   The Role of Oblique Lateral Radiographs and Oblique Sagittal MRI in Diagnosing Cervical Radiculopathy and Myeloradiculopathy: A Correlative Analysis 
Trial Acronym   
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  Principal Investigator and Spine Surgeon 
Affiliation  Stavya Spine Hospital And Research Institute 
Address  Room no. 9 - Second floor Annexe,Department - Research department,Stavya Spine hospital and Research Institute,Mithakhali, Ellisbridge.

Ahmadabad
GUJARAT
380006
India 
Phone  09825019913  
Fax  07926408174  
Email  brd_172@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bharat R Dave 
Designation  Principal Investigator and Spine Surgeon 
Affiliation  Stavya Spine Hospital And Research Institute 
Address  Room no. 9 - Second floor Annexe,Department - Research department,Stavya Spine hospital and Research Institute,Mithakhali, Ellisbridge.

Ahmadabad
GUJARAT
380006
India 
Phone  09825019913  
Fax  07926408174  
Email  brd_172@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Bharat R Dave 
Designation  Principal Investigator and Spine Surgeon 
Affiliation  Stavya Spine Hospital And Research Institute 
Address  Room no. 9 - Second floor Annexe,Department - Research department,Stavya Spine hospital and Research Institute,Mithakhali, Ellisbridge.

Ahmadabad
GUJARAT
380006
India 
Phone  09825019913  
Fax  07926408174  
Email  brd_172@yahoo.com  
 
Source of Monetary or Material Support  
Room no. 9, second floor Annexe Department Research department Stavya Spine Hospital and Research Institute Ellisbridge,Mithakhali. 
 
Primary Sponsor  
Name  Stavya Spine Hospital and Research Institute 
Address  Room No-9, 2nd floor Annexe , Department-Research department Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmadabad GUJARAT 380006 India  
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 
Dr Bharat R Dave  Stavya Spine Hospital & Research Institute  Room No-9, 2nd floor Annexe , Department-Research department Stavya Spine hospital and Research Institute Ellisbridge Mithakhali,380006.
Ahmadabad
GUJARAT 		 09825019913
07926408174
brd_172@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Stavya Spine hospital & Research Institute IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S142||Injury of nerve root of cervical spine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Age - 18 and above
2.Patients with symptoms of cervical radiculopathy, with or without myelopathy.
3.Willing to undergo radiographic and MRI scans. 
 
ExclusionCriteria 
Details  1.Patients with only cervical myelopathy symptoms without radiculopathy.
2.Patients with associated pathologies such as infection or malignancy.
3.Patients unwilling to be a part of study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
For co-relation between clinical symptoms are radiological evidence of foraminal stenosis, Spearman’s rank correlation coefficient.
For co-relation between VAS and NDI with radiological evidence of foraminal stenosis, Pearson’s correlation coefficient shall be used.
 		 12 month  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   09/05/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Cases with cervical spine radicular symptoms are on a rise due to demographic shift towards more ageing population, poor ergonomics related to occupation, lack of physical exercises and sedentary lifestyles. A significant proportion of these symptoms are due to the compression of cervical nerve roots at the intervertebral foramen level. This compression can be attributed to disc degeneration and lateral herniation, uncinate process osteophytes and facetal overgrowth that results into narrowing of the exiting neural foramen causing foraminal stenosis . The anatomical orientation of these foramen is oblique, lying around 45° from the sagittal plane. Hence, standard anteroposterior (AP) and lateral view radiographs of cervical spine do not provide much inference regarding the status of cervical inter-vertebral foramen, as compared to 45° oblique angled radiographs where x-rays are projected perpendicular to the foramen cross-section and its boundaries can be outlined. Similarly, traditional sagittal MRI images are also unable to provide clear views of the foramen, whereas the 45° oblique sagittal view creates a cervical image similar to lumbar sagittal views . This can facilitate in correct diagnosis of cervical intervertebral foraminal stenosis and predict prognosis and determine appropriate treatment options. 
Close