| CTRI Number |
CTRI/2024/07/069736 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between ultrasound guided triamcinolone (steroid) injection in sacroiliac joint (a joint in the lower back) and oral Etoricoxib (a painkiller) in patients with spondyloarthritis |
|
Scientific Title of Study
|
Comparison between ultrasound-guided injection of triamcinolone in sacroiliac joints and oral Etoricoxib in patients with axial spondyloarthritis: a randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Shyamashis Das |
| Designation |
Consultant Rheumatologist |
| Affiliation |
Institute of Neurosciences Kolkata |
| Address |
Institute of Neurosciences Kolkata. 185, Acharya Jagadish Chandra Bose Road, Elgin, Kolkata, West Bengal 700017
Kolkata
WEST BENGAL
700017
India |
| Phone |
91-9433654275 |
| Fax |
91-33-22867097 |
| Email |
drshyamashis@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shyamashis Das |
| Designation |
Consultant Rheumatologist |
| Affiliation |
Institute of Neurosciences Kolkata |
| Address |
Institute of Neurosciences Kolkata. 185, Acharya Jagadish Chandra Bose Rd, Elgin, Kolkata, West Bengal 700017
Kolkata
WEST BENGAL
700017
India |
| Phone |
91-9433654275 |
| Fax |
91-33-22867097 |
| Email |
drshyamashis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Shyamashis Das |
| Designation |
Consultant Rheumatologist |
| Affiliation |
Institute of Neurosciences Kolkata |
| Address |
Institute of Neurosciences Kolkata. 185, Acharya Jagadish Chandra Bose Rd, Elgin, Kolkata, West Bengal 700017
Kolkata
WEST BENGAL
700017
India |
| Phone |
91-9433654275 |
| Fax |
91-33-22867097 |
| Email |
drshyamashis@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Neurosciences Kolkata, 185/1 A.J.C. Bose Road, Kolkata - 700017, West Bengal, India. Pincode 700017 |
|
|
Primary Sponsor
|
| Name |
INSTITUTE OF NEUROSCIENCES KOLKATA |
| Address |
INSTITUTE OF NEUROSCIENCES KOLKATA, 185, Acharya Jagadish Chandra Bose Rd, Elgin, Kolkata, West Bengal 700017 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shyamashis Das |
Institute of Neurosciences Kolkata (Annex building) |
Department of Rheumatology, Annex building, 4th Floor, 10 West Range, Beckbagan, Kolkata, West Bengal 700017
Kolkata
WEST BENGAL |
91-9433654275
91-33-22867097
drshyamashis@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of the Institute of Neurosciences Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M458||Ankylosing spondylitis sacral andsacrococcygeal region, (2) ICD-10 Condition: M458||Ankylosing spondylitis sacral andsacrococcygeal region, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oral Etoricoxib daily for 12 weeks |
Patients with Active disease defined by Bath ankylosing spondylitis disease activity index (BASDAI) score ≥ 4 or ASDAS ≥ 2.1, will be randomized in 1:1 ratio, in two arms. In the first arm, patients will receive ultrasound guided triamcinolone acetate injection in S.I. joint and in the other arm patients will receive oral etoricoxib. Dose of etoricoxib will be 90mg - 60mg once in a day and to be given for 12 weeks. |
| Intervention |
Ultrasound guided administration of injection Triancelonose (40mg) in each sacro-iliac (S.I.) joint - single intervention |
Patients with Active axial spondyloarthritis, defined by Bath ankylosing spondylitis disease activity index (BASDAI) score ≥ 4 or ASDAS ≥ 2.1, will be randomized in 1:1 ratio in two arms. In the first arm, patients will receive Ultrasound guided triancelonose acetonide injection in S.I. joints and in the other arm patients will receive oral etoricoxib. Dose of injection triamcinolone acetonide will be 40mg, mixed with 1ml of injection lignocaine hydrochloride (2%), for each S.I. joint. The procedure will be done using standard aseptic measures. Patients will be given the injection only single time, at baseline, and will be followed up for 12 weeks to see its effects till 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
i. Patients ≥ 18 years of age
ii. Fulfilling the ASAS classification criteria of Axial Spondyloarthritis 2011.
iii. Active disease defined by Bath ankylosing spondylitis disease activity index (BASDAI) score ≥ 4, or ASDAS ≥ 2.1.
|
|
| ExclusionCriteria |
| Details |
1. Bony ankylosis of sacroiliac joint - Grade 4 sacroilitis according to the modified New York criteria
2. Patients with only peripheral spondyloarthropathy
3. Predominantly Psoriatic arthritis
4. Predominantly Enteropathic arthritis
5. Patients on biologics and JAK inhibitors
6. Allergy to etoricoxib
7. Contraindication to NSAIDs
8. Pregnancy or lactation at the time of study entry
8. Infective sacroiliitis
10. History of corticosteroid injection in the sacroiliac joint within six months before study entry
11. Malignancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease of spinal pain score (VAS 0-10 scale) at 12 weeks |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ASDAS (Ankylosing Spondylitis Disease Activity Score) improvement |
12 weeks |
| Bath ankylosing spondylitis disease activity index (BASDAI) 50 response |
12 weeks |
| Reduction in CRP levels in blood at 12 weeks |
12 weeks |
| NSAID index at 12 weeks |
12 weeks |
| Any adverse effect in both the arms |
12 weeks |
|
|
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)
|
01/08/2024 |
| 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 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
|
Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as first-line treatment, followed by biologic disease-modifying antirheumatic drugs (bDMARDs). However, in some patients NSAID is contraindicated, e.g., patients with renal or hepatic dysfunction. Furthermore, some patients may not tolerate NSAID. For such patients ultrasound guided steroid injections in the sacroiliac (S.I) joints may give pain relief and abate inflammation. However, there is paucity of good quality data on efficacy of steroid injection in S.I. joint. In this open label randomised trial we would like to investigate the comparative efficacy and safety between ultrasound guided Triamcenolone acetonide injection in S.I. joint and oral etoricoxib in axial spondyloarthritis patients. Patients with Active axial spondylosrthritis defined by Bath ankylosing spondylitis disease activity index (BASDAI) score ≥ 4 or ASDAS ≥ 2.1, will be randomized in 1:1 ratio, using an online random number generator, in two arms. In the first arm, patients will receive ultrasound guided Triamcenolone acetonide injection in S.I. joints (single intervention) and in the other arm patients will receive oral etoricoxib for 12 weeks and they will be followed up to 12 weeks. Primary outcome of this study is decrease of spinal pain score (VAS 0-10 scale) at 12 weeks, and the secondary outcomes are ASDAS (Ankylosing Spondylitis Disease Activity Score) improvement, Bath ankylosing spondylitis disease activity index (BASDAI) 50 response, reduction in CRP levels in blood, NSAID index and adverse effects at 12 weeks. |