| CTRI Number |
CTRI/2025/02/081064 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To know the effectiveness of addition of 3% hypertonic saline to steroid injection which is injected in lower back for pain management in patients with chronic low backache. |
|
Scientific Title of Study
|
Effect of adjuvant hypertonic saline in Transforaminal Epidural Steroid injection for the management of patients with chronic lumbosacral radiculopathy: A double blind, prospective, randomized trial. |
| 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 Anushka Agrawal |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 5011 Fifth floor, Academic block, Office of Department of anesthesiology, pain medicine and critical care AIIMS, New Delhi
South
DELHI
110049
India |
| Phone |
9310372695 |
| Fax |
|
| Email |
anushka.agrawal1693@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Christopher Dass |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 5011 Fifth floor, Academic block, Office of Department of anesthesiology, pain medicine and critical care AIIMS, New Delhi
South
DELHI
110049
India |
| Phone |
9560177416 |
| Fax |
|
| Email |
christopherdass25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Christopher Dass |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 5011 Fifth floor, Academic block, Office of Department of anesthesiology, pain medicine and critical care AIIMS, New Delhi
South
DELHI
110049
India |
| Phone |
9560177416 |
| Fax |
|
| Email |
christopherdass25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 5011, Fifth floor, Academic block, Department of Anesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi, 110029, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar, New Delhi, 110049 |
| 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 Anushka Agrawal |
All India Institute of Medical Sciences |
Room no. 5011, Fifth floor, Academic block, Office of Department of Anesthesiology, pain medicine and critical care, OT complex, AIIMS, Ansari Nagar, New Delhi, 110029, India
South
DELHI |
9310372695
anushka.agrawal1693@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% normal saline |
2ml of 0.9% normal saline mixed with 1ml of 1% lignocaine and 20mg of triamcinolone injected using proper aseptic precautions via transforaminal epidural injection route |
| Intervention |
3% hypertonic saline |
2ml of 3% hypertonic saline mixed with 1ml of 1% lignocaine and 20mg of triamcinolone injected using proper aseptic precautions via transforaminal epidural injection route |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with unilateral lumbosacral radicular pain of more than 3 months duration
ASA class 1 and 2 patients consenting for the study |
|
| ExclusionCriteria |
| Details |
Patients not consenting for the study
Known hypersensitivity to local anesthetic
Patient having an infection at the site of intervention
Patients on anticoagulation therapy
Patients lost to follow up before 3 month evaluation
Patients with untreated psychiatric illness that would interfere with pain perception and assessment
Patients with symptomatic cardiac and respiratory diseases
History of spine surgery or trauma to spine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the mean NRS (Numerical Rating Scale) score compared with baseline |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the mean NRS (Numerical Rating Scale) after 24 hours, 48 hours and 1 month compared with baseline |
24 hours, 48 hours and 1 month |
| Reduction in the mean Oswestry Disability Index (ODI) score at 3 and 6 months compared with baseline |
3 months and 6 months |
| Global Perceived Effect (GPE) measured using 7 point Likert scale for satisfaction at 3 and 6 months |
3 months and 6 months |
| Incidence of adverse events |
6 months |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
06/03/2025 |
| 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="2"
Months="0"
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
|
Low backache is one of the leading causes of disability in the world’s middle and older populations. Low backpain impairs middle-aged people’s productivity and quality of life. Chronic lumbosacral radiculopathy is one of the important differential diagnoses of low backache. Chronic lumbosacral radiculopathy refers to a pain syndrome characterized by the compression or irritation of nerve roots in the lumbosacral region of the spine. Transforaminal Epidural steroid injection is used in patients when all conservative management has failed. Many adjuvants have been added to the steroid injection and hypertonic saline is one of such agent that has generated interest in recent literature.
Hypertonic saline (HS) has been recently proposed to be a useful adjuvant in TFESI for the management of chronic lumbosacral radicular pain. HS is believed to have a substantial anti-inflammatory action through its osmotic action which translocate the fluid from intracellular to extracellular space. In addition to this, HS has been shown to reduce the inflammatory cytokines and acute phase reactants while also inhibiting the leukocyte migration at the site of inflammation. Likewise, HS has cytotoxic effects on fibrous tissues, which are formed in and around degenerated, herniated disc. Since spinal nerve root inflammation and oedema lies at the core of chronic lumbosacral radiculopathy, HS could have an additional positive effect on pain management in this condition.
Multiple studies have reported HS to be effective for radicular pain in lumbosacral radiculopathy secondary to herniated disc, spinal stenosis, and post laminectomy syndrome. Manchikanti et al. showed significant clinical improvement with the epidural administration of HS for adhesiolysis. However, these studies contain significant limitations such as small sample size, the confounding effect of additional agents like hyaluronidase, and shorter follow-up periods. Therefore, we aimed to determine the effect of an adjuvant HS in transforaminal ESI in pain management of chronic lumbosacral radiculopathy. We hypothesize that the clinical efficacy of 3% hypertonic saline in transforaminal epidural steroid is superior to conventional transforaminal epidural steroid in patients with chronic lumbosacral radiculopathy. The aim of the study is to gather more evidence on the efficacy of adjuvant hypertonic saline in transforaminal epidural steroid injection.
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