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CTRI Number  CTRI/2025/03/082540 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 17/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Treatment trial]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Radiofrequency Ablation and Steroid Injection for Chronic Low Back Pain Due to Facet Joint Disease 
Scientific Title of Study   Randomized Controlled Trial on Comparison of Facet Joint Radiofrequency Denervation vs Facet Joint Steroid Injection in Chronic Low Back Pain of Facet Origin 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Stanzin Spalkit 
Designation  Assistant Professor 
Affiliation  AIIMS New Delhi 
Address  room number 68 department of radiodiagnosis AIIMS New Delhi Ansari Nagar East

New Delhi
DELHI
110029
India 
Phone  8860321558  
Fax    
Email  stanzn156@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Stanzin Spalkit 
Designation  Assistant Professor 
Affiliation  AIIMS New Delhi 
Address  room number 68 department of radiodiagnosis AIIMS New Delhi Ansari Nagar East

New Delhi
DELHI
110029
India 
Phone  8860321558  
Fax    
Email  stanzn156@gmail.com  
 
Details of Contact Person
Public Query  
Name  Stanzin Spalkit 
Designation  Assistant Professor 
Affiliation  AIIMS New Delhi 
Address  room number 68 department of radiodiagnosis AIIMS New Delhi Ansari Nagar East

New Delhi
DELHI
110029
India 
Phone  8860321558  
Fax    
Email  stanzn156@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Research section Ansari Nagar New Delhi India 110029 
 
Primary Sponsor  
Name  AIIMS research section 
Address  research section AIIMS New Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
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 Stanzin Spalkit  AIIMS New Delhi  room number 68 department of radiodiagnosis AIIMS New Delhi Ansari Nagar East 110029
South West
DELHI 		 8860321558

stanzn156@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee All India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: M478||Other spondylosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Facet joint radiofrequency denervation   Fluoroscopy-guided Radiofrequency denervation will be performed using a cooled tip thermal radiofrequency technique, with a target temperature of 60°C for 60-90 seconds per level at the desired site  
Comparator Agent  Facet joint steroid injection  Fluoroscopically guided intra-articular facet joint injections with steroid (methylprednisolone 20-40 mg or equivalent)using lumbar puncture needle at the desired levels  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Chronic low back pain of at least 3 months duration
2. Clinical features suggestive of facet joint origin, including paraspinal tenderness, pain worsened by extension and rotation, and absence of radicular symptoms
3. Failure of conservative therapy, including medications (e.g., NSAIDs, weak opioids) and physical therapy, for at least 6 weeks 
 
ExclusionCriteria 
Details  - Presence of radicular pain or neurological deficits suggestive of nerve root involvement
- Previous lumbar spine surgery
- Significant spinal pathology, such as fracture, tumor, infection, or instability
- Coagulopathy or systemic infection
- Allergy to study medications (local anesthetics, steroids)
- Pregnancy or lactation
- Cognitive impairment or psychiatric illness that may interfere with assessment of outcomes 
 
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 
Low Back Pain intensity as measured by the NRS (0-10)   At baseline, 1 month, 3 months, 6 months and 1 year post treatment  
 
Secondary Outcome  
Outcome  TimePoints 
Pain intensity measured by the VAS (0-100 mm)
Functional status assessed by the Modified ODI at baseline and all follow-up visits
Health-related quality of life measured by the SF-12 at baseline and all follow-up visits
Time to first repeat procedure and total number of repeat procedures during the 1-year follow-up period
Adverse events, including procedural complications, new or worsening pain, and neurological deficits, assessed at each visit
 		 baseline, 1 month, 3 months, 6 months, and 1 year post-treatment 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/04/2025 
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="2"
Months="0"
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  

Systematic reviews and guidelines suggest that radiofrequency denervation can provide clinically meaningful pain relief for 6-12 months or longer. However, the relative effectiveness of radiofrequency denervation compared to intra-articular steroid injection remains uncertain.

There is a need for additional high-quality, randomized studies evaluating the comparative effectiveness of these two approaches for facet-mediated low back pain.

This randomized controlled trial aims to compare the effectiveness of RF denervation versus intra-articular steroid injection for chronic lumbar facetogenic pain not responding to conservative management.

 
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