| CTRI Number |
CTRI/2022/09/046007 [Registered on: 28/09/2022] Trial Registered Prospectively |
| Last Modified On: |
22/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [therapeutic intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of ultrasound and fluoroscopic guided facet joint injection in low back pain patients due to facet joint involvement |
|
Scientific Title of Study
|
Comparative evaluation of ultrasound-guided and fluoroscopic-guided facet joint injection in patients with facet joint pain- a prospective randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajit Kumar |
| Designation |
Additional professor |
| Affiliation |
All India institute of medical sciences Rishikesh |
| Address |
AIIMS Rishikesh
Virbhadra road
near barrage
Rishikesh
Dehradun UTTARANCHAL 249203 India |
| Phone |
9910789377 |
| Fax |
|
| Email |
ajitdr.ajit@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sonal Goyal |
| Designation |
DM resident |
| Affiliation |
All India institute of medical sciences Rishikesh |
| Address |
AIIMS Rishikesh
Virbhadra road
near barrage
Rishikesh
Dehradun UTTARANCHAL 249203 India |
| Phone |
9454269921 |
| Fax |
|
| Email |
sonalg06@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sonal Goyal |
| Designation |
DM resident |
| Affiliation |
All India institute of medical sciences Rishikesh |
| Address |
AIIMS Rishikesh
Virbhadra road
near barrage
Rishikesh
Dehradun UTTARANCHAL 249203 India |
| Phone |
9454269921 |
| Fax |
|
| Email |
sonalg06@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of medical sciences Rishikesh |
|
|
Primary Sponsor
|
| Name |
All India institute of medical sciences Rishikesh |
| Address |
Virbhadra road
near barrage
Rishikesh-249203
|
| Type of Sponsor |
Research institution |
|
|
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 Ajit Kumar |
Room no 16, pain division, Anaesthesiology department |
AIIMS Rishikesh
Virbhadra road
near barrage Dehradun UTTARANCHAL |
9910789377
ajitdr.ajit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M190||Primary osteoarthritis of other joints, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fluoroscopic guided facet joint injection |
1% lignocaine and 40 mg depot methylprednisolone injection will be given at painful unilateral facet joint in low back area under Fluoroscopic guidance |
| Intervention |
Ultrasound guided facet joint injection |
1% lignocaine and 40 mg depot methylprednisolone injection will be given at painful unilateral facet joint in low back area under ultrasound guidance |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Chronic LBP with or without proximal non-radicular extremity pain
2. Duration of pain at least more than 3 months
3. Pain unresponsive to conservative treatment including medical management, physical therapy, and previous interventions.
4. Average pain score of ≥4 on an 11-point NRS.
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. more than one facet joint or bilateral facet joint involvement
3. Pain for less than 3 months
4. Coagulopathy and/or patients on anticoagulants.
5. Infection at the site of injection.
6. Hypersensitivity to local anesthetic agent.
7. Evidence of significant progressive sensory or motor deficit, cauda-equina syndrome, H/O trauma, infection and cancer (Red flag signs).
8. Evidence of severe psychiatric illness.
9. History of spinal tumor, spinal cord injury or previous backs surgery
10.History of any major comorbid medical conditions, those interfere with recording of study outcomes (neurological disorders, auto-immune diseases), multiple sclerosis, and pregnancy.
|
|
|
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 |
| Pain score [11-point numeric rating scale (NRS 11) score] in both the groups |
1 week, 1 month, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. GPE (Global Perceived Effect) as measured by Likert scale 7-point scoring system to assess patient satisfaction and improvement.
2. Improvement in functional status as measured by Ronald Morris Questionnaire at respective time intervals.
3. Successful outcomes were defined as patients with ≥50% or ≥ 4 points reduction in NRS score and ≥50% or ≥6 points improvement in GPE (Global Perceived Effect) will be calculated.
4. Performance time will be recorded. For the US guidance, performance time is defined as the time interval between the point of contact of the US probe with the patient’s skin and the completion of the injectate. For FL guidance, performance time is defined as the temporal interval between the first radiographic image and the end of the injection.
5. Procedural complications (if any)
|
1 week, 1 month, 3 months |
|
|
Target Sample Size
|
Total Sample Size="94" Sample Size from India="94"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2022 |
| 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 Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
|
Lumbar facet joints have been
implicated in the cause of chronic low back pain in 15% to 45% of patients,
which was based upon their responses toward controlled, diagnostic blocks
according to the criteria set by the International Association for the Study
of Pain. Treatment effects for facet join pain in 3 types of intervention,
including intraarticular injection, medial branch nerve block, and neurolysis
using radiofrequency, have been reported. These treatment options have been
implicated in refractory cases of facet joint pain who are not responsive to
conservative management. Appropriate management methods for the facet joint
pain are still in argument. Facet joint intra-articular (IA)
injection are conventionally and preferably performed under fluoroscopy (FL) or
computed tomography (CT)-guided. Both guidance modalities deliver significant
radiation doses and require, at least in part, expensive equipment. However,
an ultrasound (US)-guided approach can be safe and reliable without radiation
exposures. Recently, many studies have demonstrated the reliability of
ultrasound (US) guidance for different spinal injections. Ultrasound provides
real-time monitoring, is a relatively inexpensive image guidance modality,
does not produce ionizing radiation, and is broadly available. We hypothesized that US-guided facet
IA injection provides non-inferior analgesic efficacy and functional outcome
as compared to conventional FL-guided injection without any risk of radiation
exposure with added advantages of cost-effective, feasible, easily accessible,
portable, and real time visualization of needle and surrounding structure.
|
Very few trials have been conducted till date. Therefore,
we planned this trial with the aim to evaluate the comparative efficacy of the
two different image-guided (US-guided and FL-guided) modalities in performing
facet joint intra-articular (IA) injections in patients with chronic lumbar facet
joint syndrome in terms of pain relief and quality of life improvement |