| CTRI Number |
CTRI/2024/06/069051 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Epidural Injection With or Without Steroid For Low Back Pain |
|
Scientific Title of Study
|
Efficacy Of Interlaminar Epidural Injection With or Without Steroid For Low Back Pain Due To Lumbar Canal Stenosis: A Randomised Double Blind Study. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PAWAN KUMAR DUBEY |
| Designation |
PG RESIDENT |
| Affiliation |
GEETANJALI MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM- B6,
PAIN CLINIC,
GROUND FLOOR,
GEETANJALI MEDICAL COLLEGE AND HOSPITAL
Udaipur RAJASTHAN 313001 India |
| Phone |
08009662664 |
| Fax |
|
| Email |
pawandubey131@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR ANIL KUMAR BHIWAL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
GEETANJALI MEDICAL COLLEGE AND HOSPITAL |
| Address |
SECOND FLOOR, ANAESTHESIA DEPARTMENT,
GEETANJALI MEDICAL COLLEGE AND HOSPITAL
Udaipur RAJASTHAN 313001 India |
| Phone |
9799185525 |
| Fax |
|
| Email |
anilbhiwal@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
DR ANIL KUMAR BHIWAL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
GEETANJALI MEDICAL COLLEGE AND HOSPITAL |
| Address |
SECOND FLOOR,
ANAESTHESIA DEPARTMENT,
GEETANJALI MEDICAL COLLEGE AND HOSPITAL
Udaipur RAJASTHAN 313001 India |
| Phone |
9799185525 |
| Fax |
|
| Email |
anilbhiwal@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| GEETANJALI HOSPITAL,
MANWAKHERA, NH-8 BYPASS, NEAR EKLINGPURA CHOURAHA, RAJASTHAN 313001 |
|
|
Primary Sponsor
|
| Name |
DR PAWAN KUMAR DUBEY |
| Address |
GEETANJALI MEDICAL COLLEGE AND HOSPITAL , UDAIPUR, RAJASTHAN |
| Type of Sponsor |
Other [SELF] |
|
|
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 PAWAN KUMAR DUBEY |
GEETANJALI HOSPITAL |
ROOM B-6, GROUND FLOOR, GEETANJALI MEDICAL COLLEGE AND HOSPITAL Udaipur RAJASTHAN |
8009662664
pawandubey131@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL CLEARENCE CERTIFICATE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G892||Chronic pain, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTERLAMINAR EPIDURAL INJECTION |
epidural injection with steroid: Ropivacaine (0.2%) 5ml + Triamcinolone 40 mg (1 ml)
|
| Comparator Agent |
INTERLAMINAR EPIDURAL INJECTION |
epidural injection without steroid:
Ropivacaine (0.2%) 5ml + normal saline (0.9 %) 1 ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having chronic lower back pain due lumbar canal stenosis as evident from radiological findings on MRI. |
|
| ExclusionCriteria |
| Details |
Patients with-
1) Contraindication to the procedure (active, local or systemic infections), coagulopathy, use of anti thrombotic or anti platelet medications.
2) History of allergy to contrast medium or injected medication.
3)Previous history of low back surgery.
4)Lower Back Pain due to PIVD.
5)Pre-existing uncontrolled hypertension, uncontrolled diabetes mellitus type 2.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the efficacy of lumbar interlaminar epidural injection (ILEI) with following parameters in both the groups:
a) Reduction of pain by visual analogue scale (VAS) at 1, 3 and 6 months.
b) Improvement of functional status by walking distance and Revised Oswestry Disability Index at 1, 3 and 6 months.
|
a) Reduction of pain by visual analogue scale (VAS) at 1, 3 and 6 months.
b) Improvement of functional status by walking distance and Revised Oswestry Disability Index at 1, 3 and 6 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the following parameters in both groups:
a) Requirement of repeat ILEI.
b) Adverse effects (PDPH, hypotension, bradycardia, nausea/vomiting, vasovagal reaction intrathecal/intravascular injection, allergic reactions etc.)
|
At 4 weeks , 12 weeks & 48 Weeks |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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 4 |
|
Date of First Enrollment (India)
|
30/06/2024 |
| 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="7" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
Spinal canal stenosis is the
narrowing of the spinal canal which results in spinal cord and spinal nerve
compression. It can cause back and leg pain, limb weakness, and
numbness. Patients with symptomatic spinal canal stenosis have reduced activity
which further leads to development of other serious complications.
The cause of the
disease is generally degenerative. Acquired spinal canal stenosis is very
common among elderly patients, with a prevalence of 1.7% - 13.1%. Primary
treatment is conservative management, but in many cases when conservative
therapy is not effective then surgical treatment is selected. But even after
surgery symptoms may persist and long term benefits of surgery is reported to
be less compared to conservative management. The risk of anesthesia and
postoperative complication is also increased in elderly patients.
An epidural
steroid injection is a non-operative minimally invasive procedure used for pain
relief in spinal canal stenosis. The main aim is
providing effective and long lasting pain relief with improvement in functional
status for the management of chronic back pain and lower extremity pain. Various studies have been conducted to evaluate the efficacy
of this treatment in the management of patients with spinal canal stenosis with
highly variable success rate, still there is no consensus on its effect size
nor on the timing of the trial, frequency, and duration of treatment. So further studies are required to understand the effectiveness of epidural
steroid injection in the treatment of spinal canal stenosis.
Therefore this
study is planned to evaluate the efficacy of interlaminar epidural steroid
injection for back pain due lumbar canal stenosis. |