| CTRI Number |
CTRI/2024/05/068152 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the effectiveness of two steroid drugs (methylprednisolone and triamcinolone) in epidural injection to reduce chronic pain in lower back and legs |
|
Scientific Title of Study
|
Comparison of the efficacy of fluoroscopic guided
caudal epidural injection of methylprednisolone
versus triamcinolone in patients with degenerative
lumbar canal stenosis |
| 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 M Priyadarshini |
| Designation |
Junior resident |
| Affiliation |
Government Medical College and Hospital,Chandigarh Sector 32 |
| Address |
Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH,Sector 32-B,Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
7042035517 |
| Fax |
|
| Email |
priya35517@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dheeraj Kapoor |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital,Chandigarh Sector 32 |
| Address |
Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH,Sector 32-B,Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121549 |
| Fax |
|
| Email |
kapoor.dheeraj72@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Priyadarshini |
| Designation |
Junior resident |
| Affiliation |
Government Medical College and Hospital,Chandigarh Sector 32 |
| Address |
Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH,Sector 32-B,Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
7042035517 |
| Fax |
|
| Email |
priya35517@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive care,Block D,Level 5,Government Medical College and Hospital,Sector 32-B,Chandigarh,160030 India |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive care,Block D,Level 5,Government Medical College and Hospital,Sector 32-B,Chandigarh 160030 India |
| 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 M Priyadarshini |
Government Medical College and Hospital |
Department of Anaesthesia and Intensive care, Block D,Level 5,Government medical college and hospital ,Sector 32-B,Chandigarh,Pin Code-160030
Chandigarh
CHANDIGARH |
7042035517
priya35517@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,GMCH,Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M480||Spinal stenosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
caudal epidural injection of methylprednisolone acetate with hyaluronidase |
Fluroscopic guided caudal epidural injection of methylprednisolone acetate with hyaluronidase as adjuvant will be given in patients diagnosed with degenerative lumbar canal stenosis.The analgesic efficacy of the above mentioned drug will be compared through the pain assessment by VAS score at pre intervention and 1,2 and 3 month post intervention. Similarly functional status by Swiss spinal stenosis score ,patient satisfaction level by Likert 5 point scale will be assessed at pre intervention,1,2 and 3 month post intervention. |
| Intervention |
caudal epidural injection of triamcinolone acetonide with hyaluronidase |
Fluroscopic guided caudal epidural injection of triamcinolone acetonide with hyaluronidase as adjuvant will be given in patients diagnosed with degenerative lumbar canal stenosis.The analgesic efficacy of the above mentioned drug will be compared through the pain assessment by VAS score at pre intervention and 1,2 and 3 month post intervention. Similarly functional status by Swiss spinal stenosis score ,patient satisfaction level by Likert 5 point scale will be assessed at pre intervention,1,2 and 3 month post intervention. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed signs and symptoms suggestive of neurogenic claudication pain
refractory to conservative treatment for more than 3 months.
2. Age range between 40 and 80 years.
3. Magnetic Resonance Imaging (MRI) based Lee’s Grading 1 to 3 for lumbar central canal
or foraminal stenosis. |
|
| ExclusionCriteria |
| Details |
1. Previous history of lumbar surgery
2. Back or leg pain due to other etiologies (e.g. spinal fracture, metastasis, neuropathy,
vascular claudication etc.)
3. Pregnancy and lactating women
4. Severe bleeding diathesis or on anticoagulation therapy
5. Patient with severe heart, lung, hepatic, renal, psychiatric, connective tissue disorder,
neurological, uncontrolled diabetes mellites or hypertension
6. Presence of systemic infection or local infection at the injection site
7. Significant allergic reaction or hypersensitivity to contrast, anaesthetic, or corticosteroids
8. Patient diagnosed with malignancy
9. Patient on uncontrollable or unstable opioid use
10. Patient having severe motor weakness, rapidly progressing neurological deficit, or cauda
equina syndrome |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the analgesic efficacy of fluoroscopically guided caudal epidural injection of
methylprednisolone versus triamcinolone with hyaluronidase as adjuvant, using ‘visual
analogue scale’ in patients with lumbar canal stenosis. |
Pain assessment of patient by VAS score at pre-intervention, 1, 2, and 3-month post-
intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the functional outcomes achieved by administering fluoroscopically guided
caudal epidural injection of methylprednisolone versus triamcinolone with hyaluronidase
as adjuvant, using ‘Swiss Spinal Stenosis’ score. |
Functional status of patient by SSS score at pre-intervention, 1, 2, and 3-month post-
intervention. |
2. To compare the patient satisfaction outcomes achieved by administering fluoroscopically
guided caudal epidural injection of methylprednisolone versus triamcinolone with
hyaluronidase as adjuvant, using five-point ‘Likert scale’. |
Patient satisfaction level by Likert 5 -point scale at pre-intervention, 1, 2, and 3-month
post-intervention. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/06/2024 |
| 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="6"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
Lumbar canal stenosis (LCS) causes neurogenic claudication, radicular pain and functional disability, especially in the elderly. Initial conservative management includes medications, physical therapy and epidural steroid injections (ESI). ESIs provide short-term relief by reducing inflammation around nerve roots. Caudal ESIs allow access to lower lumbar levels and provide significant relief to the symptoms. Previous studies compared particulate vs non-particulate steroids with conflicting efficacy results. Hyaluronidase may enhance steroid spread and duration when used as an adjuvant through reducing fibrosis and facilitating spread. However, there is a lack of studies directly comparing triamcinolone and methylprednisolone combined with hyaluronidase for fluoroscopic-guided caudal ESIs in LCS. This prospective randomized study aims to compare the analgesic efficacy and functional outcomes of fluoroscopic caudal epidural injections of triamcinolone vs methylprednisolone, using hyaluronidase as an adjuvant, in symptomatic degenerative LCS patients. Outcomes will be assessed using scales like VAS, Likert, and Swiss Spinal Stenosis questionnaire. Aim
To compare efficacy of fluoroscopic guided caudal epidural injection of methylprednisolone versus triamcinolone in degenerative lumbar canal stenosis patients.
Objectives
1 To compare the analgesic efficacy of fluoroscopically guided caudal epidural injection of methylprednisolone versus triamcinolone with hyaluronidase as adjuvant, using ‘visual analogue scale’ in patients with lumbar canal stenosis.
2. To compare the functional outcomes achieved by administering fluoroscopically guided caudal epidural injection of methylprednisolone versus triamcinolone with hyaluronidase as adjuvant, using ‘Swiss Spinal Stenosis’ score.
3. To compare the patient satisfaction outcomes achieved by administering fluoroscopically guided caudal epidural injection of methylprednisolone versus triamcinolone with hyaluronidase as adjuvant, using five-point ‘Likert scale’.
Methodolgy
This section outlines the initial preparation, randomization, allocation, and blinding process for the study comparing caudal epidural triamcinolone versus methylprednisolone with hyaluronidase in lumbar canal stenosis patients. - Patients meeting inclusion criteria will undergo pre-procedure investigations, mri classification, and baseline assessments (VAS, SSS scores).
- 60 patients will be randomly allocated to Group 1 (methylprednisolone 80mg, ropivacaine 0.2%, hyaluronidase 1500IU) or Group 2 (triamcinolone 80mg, ropivacaine 0.2%, hyaluronidase 1500IU) using sealed opaque envelopes.
- The study will be double-blinded with patients and interventionists unaware of group allocation.
- On the procedure day, patients will be positioned prone, prepped with all aseptic precautions, and the caudal epidural space identified under fluoroscopy.
- After negative aspiration, the 20ml study drug solution will be injected as per allocated group.
- Patients will be monitored post-procedure for any complications like hypotension, dural puncture, allergic reactions which will be managed accordingly.
Following observations will be recorded in all patients: 1. Pain assessment of patient by VAS score at pre-intervention, 1, 2, and 3-month post- intervention. 2. Functional status of patient by SSS score at pre-intervention, 1, 2, and 3-month post- intervention. 3. Patient satisfaction level by Likert 5 -point scale at pre-intervention, 1, 2, and 3-month post-intervention. 4. Any immediate or delayed complications due to caudal ESI will be recorded during or post-intervention. |