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CTRI Number  CTRI/2024/08/072586 [Registered on: 16/08/2024] Trial Registered Prospectively
Last Modified On: 04/06/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Prevalence of hand signs in myelopathy  
Scientific Title of Study   To study the prevalence of hand signs in cervical spondylotic myelopathy: A prospective cohort analysis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SSHRI/CS/NS/Handsign/RR/70/07.24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Raviranjan Rai 
Designation  Principal Investigator and Spine Surgeon 
Affiliation  Stavya Spine Hospital And Research Institute 
Address  No.9 2nd floor Annexe Research Department Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad 380006 Ahmadabad,GUJARAT,380006,India

Ahmadabad
GUJARAT
380006
India 
Phone  9726820898  
Fax  07926408174  
Email  drravirai84@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Raviranjan Rai 
Designation  Principal Investigator and Spine Surgeon 
Affiliation  Stavya Spine Hospital And Research Institute 
Address  No.9 2nd floor Annexe Research Department Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad 380006 Ahmadabad,GUJARAT,380006,India


GUJARAT
380006
India 
Phone  9726820898  
Fax  07926408174  
Email  drravirai84@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Raviranjan Rai 
Designation  Principal Investigator and Spine Surgeon 
Affiliation  Stavya Spine Hospital And Research Institute 
Address  No.9 2nd floor Annexe Research Department Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad 380006 Ahmadabad,GUJARAT,380006,India


GUJARAT
380006
India 
Phone  9726820898  
Fax  07926408174  
Email  drravirai84@gmail.com  
 
Source of Monetary or Material Support  
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad 380006 
 
Primary Sponsor  
Name  Stavya Spine Hospital and Research Institute 
Address  Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad 380006 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Raviranjan Rai  Stavya Spine Hospital & Research Institute  Research Department,No. 9 2nd floor Annexe, Stavya Spine hospital and Research Institute,Ellisbridge Mithakhali,Ahmedabad 380006,GUJARAT
Ahmadabad
GUJARAT 
9726820898
07926408174
drravirai84@gmail.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: G992||Myelopathy in diseases classifiedelsewhere, (2) ICD-10 Condition: M471||Other spondylosis with myelopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All patients diagnosed with cervical myelopathy at our Centre from 1ST Aug 2024 – 1ST Jan 2024. 
 
ExclusionCriteria 
Details  Major neurodegenerative diseases such as
1.Alzheimer’s or multiple sclerosis
2.Peripheral or vascular neuropathy
3.Spinal tumours or trauma
4.Tremor
5.Diabetes
• Systemic rheumatological disease
• History of spinal surgery 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This will help in the diagnosis of cervical myelopathy  This is a single point study requiring no further follow up or clinic visits from the patient 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/08/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
Cervical spondylotic myelopathy (CSM) causes progressive spondylosis of the cervical spine, resulting in poor dexterity and hand strength.Degenerative cervical myelopathy (DCM), also known as myelopathy hand, is characterized by gait dysfunction, loss of hand dexterity, and motor/sensory dysfunction corresponding to cervical cord compression in an MRI. There exists an enormous variation in the signs and symptoms of cervical myelopathy, hence diagnosis can be challenging. Hoffmann’s sign, the finger escape sign, Grip release test, hand Grip are all considered as myelopathic sign. Modern spinal assessments in outpatient clinics rely heavily on subjective tests of motor and sensory impairment, clinical disability scales, and magnetic resonance imaging (MRI).  Little is known about how isolated clinical deficits, such as strength, proprioception, and hyperreflexia, contribute to overall clinical disability. Having a better understanding of the causes of clinical disability in CSM patients can help clinicians make informed decisions about treatment timing and follow-up, particularly for patients with mild myelopathy. 
The primary aim of this study is to assess prevalence of hand signs in a patient diagnosed with cervical spondylotic myelopathy.
 
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