| CTRI Number |
CTRI/2025/03/081694 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of two types of steroid injections for chronic neck pain with nerve-related symptoms |
|
Scientific Title of Study
|
Effectiveness of interlaminar and transforaminal approach for cervical epidural steroid injection in patients of chronic neck pain with radiculopathy |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gautam Chandra Koshi |
| Designation |
Junior Resident in Department of Anesthesiology |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Operation theatre, 2nd floor,Department of anesthesiology, Gandhi medical college, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
7974507906 |
| Fax |
|
| Email |
chandrakoshikmusic@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaideep Singh |
| Designation |
Associate Professor |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Operation theatre, 2nd floor,Department of anesthesiology, Gandhi medical college, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9827767022 |
| Fax |
|
| Email |
singhdrjaideep@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaideep Singh |
| Designation |
Associate Professor |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Operation theatre, 2nd floor,Department of anesthesiology, Gandhi medical college, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9827767022 |
| Fax |
|
| Email |
singhdrjaideep@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gandhi Medical College Block A Second Floor Operation Theatre Gandhi Medical College and Associated Hamidia hospitals Bhopal Madhya Pradesh India 462001 |
|
|
Primary Sponsor
|
| Name |
Gandhi medical college |
| Address |
Gandhi medical college, Bhopal (M.P) 462001 |
| Type of Sponsor |
Government medical college |
|
|
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 Jaideep Singh |
Hamidia Hospital |
Operation theatre, 2nd floor,Department of anesthesiology, Gandhi medical college
Bhopal
MADHYA PRADESH |
9827767022
singhdrjaideep@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
interlaminal approach |
The interlaminar approach to cervical epidural steroid injection (CESI) is a procedure in which medications, typically a corticosteroid and a local anesthetic, are administered into the epidural space of the cervical spine via the posterior approach. This method is widely used for managing pain and inflammation caused by cervical radiculopathy, herniated discs, or degenerative conditions.the procedure usually takes less than 15 minutes
|
| Comparator Agent |
transforaminal approach |
The transforaminal epidural steroid injection (TFESI) is a precise technique used to deliver medication directly to the epidural space near the affected nerve root in the cervical spine. This approach is particularly effective for conditions causing radicular pain and inflammation, such as herniated discs or foraminal stenosis. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
After obtaining approval from institutional ethics committee and informed written consent will be taken from all 80 patients. Patients belonging to ASA grade 1 & 2 of either sex .patients of chronic neck pain with radiculopathy. |
|
| ExclusionCriteria |
| Details |
Known allergy for drugs.
Patients with systemic diseases like respiratory, cardiac,hepatic, renal disease, diabetes, hypertension.
Pregnant, lactating mothers.
Patient had history of cervical spine surgery within 6 months.
Patient with bleeding diathesis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess two approaches of cervical epidural steroid injection in terms of efficiency in managing chronic neck pain |
we will measure VAS and NRS score at pre procedure than at 0,15,30,60min ,2,6,12,24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of pain reduction by cervical epidural steroid injection for patient suffering from chronic neck pain |
assessment of VAS and NRS score at pre procedure than at 0,15,30,60min ,2,6,12,24 hrs |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
21/03/2025 |
| 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="1"
Months="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [chandrakoshikmusic@gmail.com].
- For how long will this data be available start date provided 05-02-2025 and end date provided 05-02-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Cervical epidural steroid injections (CESIs) are commonly used to manage chronic neck pain with radiculopathy, a condition characterized by nerve irritation or compression leading to pain radiating from the neck to the arms. Two primary approaches for administering CESIs are the interlaminar and transforaminal techniques. The interlaminar approach delivers the steroid medication into the epidural space through a midline or paramedian insertion, allowing for broader drug distribution. Conversely, the transforaminal approach involves precise delivery near the affected nerve root, targeting the site of inflammation more directly. Both approaches are effective in reducing pain and improving functional outcomes. However, the choice of technique may depend on factors such as the location and severity of the pathology, patient anatomy, and the physician’s expertise. While the interlaminar approach is associated with a lower risk of specific complications, the transforaminal method may provide faster and more targeted relief. |