| CTRI Number |
CTRI/2020/07/026854 [Registered on: 28/07/2020] Trial Registered Prospectively |
| Last Modified On: |
24/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) [Comparison between clinical effects of ultrasound guided versus fluoroscopy guided intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of Ultrasound and Fluoroscopy guided injection in Ankylosing Spondylitis and related diseases. |
|
Scientific Title of Study
|
A comparative study between the clinical
effect of Ultrasound versus Fluoroscopy guided Sacroiliac
Joint injection in Spondyloarthropathy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Debajyoti Ghosh |
| Designation |
Post Graduate Trainee (MD) Physical Medicine and Rehabilation |
| Affiliation |
R. G. Kar Medical College and Hospital |
| Address |
Department of Physical Medicine and Rehabilitation,
R. G. Kar Medical College and Hospital,
1; Khudiram Bose Sarani, Kolkata,
Kolkata
WEST BENGAL
700004
India |
| Phone |
9153093649 |
| Fax |
|
| Email |
ghosh.debajyoti2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Debajyoti Ghosh |
| Designation |
Post Graduate Trainee (MD) Physical Medicine and Rehabilation |
| Affiliation |
R. G. Kar Medical College and Hospital |
| Address |
Department of Physical Medicine and Rehabilitation,
R. G. Kar Medical College and Hospital,
1; Khudiram Bose Sarani, Kolkata,
Kolkata
WEST BENGAL
700004
India |
| Phone |
9153093649 |
| Fax |
|
| Email |
ghosh.debajyoti2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof DR Pankaj Kumar Mandal |
| Designation |
Professor & H. O. D, Department of P. M. R, R. G. Kar Medical College and Hospital, Kolkata. |
| Affiliation |
R. G. Kar Medical College and Hospital |
| Address |
Department of Physical Medicine and Rehabilitation,
R. G. Kar Medical College and Hospital,
1; Khudiram Bose Sarani, Kolkata
Kolkata
WEST BENGAL
700004
India |
| Phone |
9831093345 |
| Fax |
|
| Email |
drpkmpmr@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| R. G. Kar Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
R G Kar Medical College and Hospital |
| Address |
1; Khudiram Bose Sarani,
Kolkata,
West bengal,
India,
Pin: 700004 |
| 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 Debajyoti Ghosh |
R. G. Kar Medical College and Hospital |
Department of P. M. R. and Pain Clinic,
R. G. Kar Medical College and Hospital,
1; Khudiram Bose Sarani, Kolkata,PIN 700004
Kolkata
WEST BENGAL |
9153093649
ghosh.debajyoti2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, R. G. Kar Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M45-M49||Spondylopathies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fluoroscopy guided injection in Sacroiliac joint |
Fluoroscopy guided Lignocaine and Corticosteroid injection in Sacroiliac joint |
| Intervention |
Ultrasound guided injection in Sacroiliac joint
|
Ultrasound guided Lignocaine and Corticosteroid injection in Sacroiliac joint
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed case of seronegative Spondyloarthropathy by ASAS criteria.
2. Pain primarily experienced between the upper level of the iliac crests and the gluteal fold.
3. Active sacroilitis clinically (positive finding of at least 3 of 6 following tests for SIJ pain)
i. Distraction or “Gappingâ€
ii. FABER/Patrick’s Test
iii. Thigh Thrust or Posterior Pelvic Pain Provocational Test
iv. Gaenslen’s Test
v. Sacroiliac Joint Compression Test
vi. Sacral Thrust or Yeoman’s Test.
4. Poorly controlled by conservative treatment for 1 month by means of both pharmacological and non-pharmacological therapy.
5. Age between 18-45 years.
6. Oswestry disability index > 40%
7. NRS (0-10) > 5.
8. Reduction of pain intensity by > 75% following a diagnostic injection.
9. Unilateral sacroilitis.
|
|
| ExclusionCriteria |
| Details |
1. Severe peripheral arthritis with hip involvement.
2. Clinical findings and imaging studies suggest other obvious cause of the pain (e.g., central spinal stenosis with neurogenic claudication/myelopathy, foraminal stenosis or disc herniation with concordant radicular pain/radiculopathy, pyriformis syndrome, infection, tumour, fracture, pain related to spinal instrumentation).
3. Degenerative sacroiliac joint or complete ankylosis of sacroiliac joint (Grade IV).
4. Patient assume prone lying position to be difficult.
5. Allergy to lignocaine, contrast dye.
6. Presence of coagulation disorder or receiving anti-coagulant therapy.
7. With other systemic disorders or active infection or other contraindications for corticosteroid injection.
8. Unwilling patient.
9. Patient unable to come to hospital for subsequent visits for follow-up.
10. Has current skin disease over the injection site.
11. Has psychiatric disorder.
12. H/o prior injection in SIJ within 2 months.
|
|
|
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 |
| 1.Severity of sacroiliac joint pain - measured by NRS (Numeric Rating Scale) [0-10] |
Baseline
1 Week
4 Weeks
12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disability due to low back pain - measured by Oswestry disability index |
Baseline
1 Week
4 Weeks
12 Weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 1 |
|
Date of First Enrollment (India)
|
31/07/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, double blinded, parallel group, single centered interventional trial comparing the clinical effect of ultrasound and fluoroscopy guided injection of
corticosteroid in sacroiliac joint in terms of pain reduction and improvement of
disability arising from lower back pain in patients of spondyloarthropathy. This study will be conducted in only one center (in India). The primary outcome measurements are change of severity of pain measured by using the NRS score (0-10) and disability due to lower back pain by Oswestry
disability index in baseline (visit 0), at 1 week (visit 1), 4 weeks (visit 2), 12 weeks (visit
3). |