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CTRI Number  CTRI/2025/02/080184 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 09/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative evaluation of ultrasound guided vs fluoroscopic guided pulsed radiofrequency ablation of medial branch in lumbar facetogenic pain: a prospective randomised study 
Scientific Title of Study   COMPARISON EVALUATION OF ULTRASOUND GUIDED Vs FLUOROSCOPIC GUIDED PULSED RADIOFREQUENCY NEUROTOMY OF MEDIAL BRANCH IN LUMBAR FACETOGENIC PAIN: A PROSPECTIVE RANDOMISED STUDY 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manasa Kantha 
Designation  senior resident 
Affiliation  All India Institute of medical sciences Rishikesh 
Address  department of anesthesiology AIIMS Rishikesh Uttarakhand

Dehradun
UTTARANCHAL
249202
India 
Phone  8985425894  
Fax    
Email  manasa5050@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ajit Kumar 
Designation  Professor 
Affiliation  All india institute of medical sciences rishikesh 
Address  department of anesthesiology AIIMS Rishikesh Uttarakhand

Dehradun
UTTARANCHAL
249202
India 
Phone  9910789377  
Fax    
Email  ajitdr.ajit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Manasa Kantha 
Designation  senior resident 
Affiliation  All india institute of medical sciences rishikesh 
Address  department of anesthesiology AIIMS Rishikesh Uttarakhand

Dehradun
UTTARANCHAL
249202
India 
Phone  8985425894  
Fax    
Email  manasa5050@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Rishikesh, Uttarakhand - 249202 
 
Primary Sponsor  
Name  Dr Manasa Kantha 
Address  All India Institute of medical sciences Rishikesh, Uttarakhand, India- 249202 
Type of Sponsor  Other [Self] 
 
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 Manasa Kantha  All India Institute of medical sciences, Rishikesh  Department Of Anesthesiology, 6th Floor, Administrative Block, Dehradun, Uttaranchal
Dehradun
UTTARANCHAL 		 8985425894

manasa5050@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comparative evaulation of fluoroscopic guided pulsed radiofrequency neurotomy of medial branch in lumbar facetogenic pain: a prospective randomised study  comparing fluoroscopic guided pulsed radiofrequency neurotomy of medial branch in lumbar facetogenic pain duration thirty minutes  
Comparator Agent  Ultrasound guided pulsed radio frequency neurotomy of medial branch in lumbar facetogenic pain  comparing ultrasound guided pulsed radiofrequency neurotomy of medial branch in lumbar facetogenic pain duration thirty minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  facet Pain unresponsive to conservative treatment including medical management, physical therapy, and previous interventions
Suspicion of facet joint mediated low back pain, exhibit clinical features consistent with possible lumbar zygapophysial joint pain, such as pain and tenderness over not more than two lumbar segments bilaterally or three segments unilaterally
patient had to be able to understand and tolerate diagnostic blocks; patient has to be positive for lumbar facet joint pain after controlled diagnostic blocks
Pain rating of more than 4 out of 10 on a NRS scale
Have diagnosis of lumbar facet syndrome after MRI, X-ray, or CT imaging of any severity and a medial branch block with local anesthetic that confirms lumbar facet pathology.
Symptom duration of 3 or more months
 
 
ExclusionCriteria 
Details  Pain for less than 3 months
Neurological deficits Pregnancy and lactating mother
Prior low back surgery with or without hardware
Concurrent cervical or thoracic pain or pain in these regions lasting longer than 2 weeks during the previous 6 months Primary or metastatic spine tumour or spinal cord injury. Allergy to medications used in procedure, blood coagulation disorder
Corticosteroid shot within last 3 months into affected lumbar facet joint because of concern of damage to cartilage in the joint in that time period. Patients with rheumatic cause of lumbar facet arthritis.
Local or systemic infection or spinal infection
Compensable disability or work injury, ongoing litigation, Prior treatment with radiofrequency neurotomy, and Discogenic pain verified by controlled discography.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the pre-intervention pain scores NRS to scores 1 month post intervention.
 		 one month post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in pain NRS with back flexion and at rest from baseline after intervention from baseline after intervention over time [ Time Frame: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention ]
2. To compare change in McNab Scores at 1 week, 1 month and 3 months.
3. To compare change in Roland Morris Scores at 1 week, 1 month and 3 months
4. Analgesic requirements according to medication quantification scale and Global Perceived effect at 3 months

 		 Time Frame: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   25/02/2025 
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="1"
Months="1"
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   This study evaluates comparison of ultrasound and fluoroscopic guided medial branch PRF in lumbar facetogenic pain, there is extensive research on medial branch blocks but limited research available for medial branch PRF. By keeping in mind regarding the hazards of radiation and operator learning curve, I want to do research on the above study. USG guided is non-inferior to fluoroscopic guided Medial branch PRF.  
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