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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
 
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