| 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
|
|
|
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
|
|
|
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. |