| CTRI Number |
CTRI/2022/01/039605 [Registered on: 20/01/2022] Trial Registered Prospectively |
| Last Modified On: |
19/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
comparison of two clinical tests for making diagnosis of neck pain caused by cervical radiculopathy in indian scenario |
|
Scientific Title of Study
|
Assessment of diagnostic accuracy of Neck
Tornado Test and Spurling Test in cervical
radiculopathy in indian scenario |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR AJIT KUMAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS RISHIKESH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,LEVEL-6, A BLOCK, AIIMS RISIKESH, UTTARAKHAND, INDIA
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH,NEAR SHIVAJI NAGAR, RISHIKESH, UTTARAKHAND
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9910789377 |
| Fax |
|
| Email |
ajitdr.ajit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GIRISH KUMAR SINGH |
| Designation |
SENIOR RESIDENT |
| Affiliation |
AIIMS RISHIKESH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, A BLOCK, LEVEL 6, AIIMS RISHIKESH, UTTARAKHAND
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9450121203 |
| Fax |
|
| Email |
dr.soonu1986@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GIRISH KUMAR SINGH |
| Designation |
SENIOR RESIDENT |
| Affiliation |
AIIMS RISHIKESH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, A BLOCK, LEVEL 6, AIIMS RISHIKESH, UTTARAKHAND
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9450121203 |
| Fax |
|
| Email |
dr.soonu1986@gmail.com |
|
|
Source of Monetary or Material Support
|
| DIVISION OF PAIN MEDICINE, DEPARTMENT OF ANAESTHESIOLOGY, AIIMS RISHIKESH, UTTARAKHAND, INDIA |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 GIRISH KUMAR SINGH |
PAIN MEDICINE O.P.D. , AIIMS RISHIKESH, INDIA |
ROOM NO-16, PAIN MEDICINE OPD, AIIMS RISHIKESH, UTTARAKHAND, INDIA
Dehradun
UTTARANCHAL |
9450121203
dr.soonu1986@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, AIIMS RISHIKESH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M541||Radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Neck Tornado Test and Spurling Test |
ONE TIME O.P.D. BASED |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age between 18 years to 65 years with neck pain who had undergone cervical spine MRI |
|
| ExclusionCriteria |
| Details |
1. Pregnancy
2. History of cervical spine surgery
3. Inflammatory disease such as rheumatoid arthritis
4. Any spinal cord deformities
5. Infective spine disease (potts spine)
6. Previous nerve block for cervical radiculopathy
7. Patient refusal
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the diagnostic accuracy of neck tornado test and spurling test. |
ONE TIME IN OPD (BASELINE) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Interpretation of efficacy for neck tornado test and spurling test in terms of its sensitivity, specificity, PPV (positive predictive value), NPV (negative predictive value). |
ONE TIME IN OPD (BASELINE) |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/01/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS STUDY IS CONDUCTED FOR THE ASSESSMENT OF DIAGNOSTIC ACCURACY OF TWO CLINICAL TESTS THAT ARE 1. SPURLING TEST 2. NECK TORNADO TEST |