FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/11/047558 [Registered on: 23/11/2022] Trial Registered Prospectively
Last Modified On: 17/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   To find the efficacy of radiofrequency ablation in the treatment of chronic low back pain 
Scientific Title of Study   The effectiveness of radiofrequency denervation of medial branch nerve in the treatment of facet mediated low back pain in adults. A prospective interventional study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ragul D 
Designation  Junior resident 
Affiliation  jss hospital 
Address  Junior resident, Department of anaesthesiology, Mahathma Gandhi road, Fort Mohalla, Ramachandra Agrahara.

Mysore
KARNATAKA
570004
India 
Phone  9566822442  
Fax    
Email  raguldharmalingam@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Srinivas H T 
Designation  ASSOCIATE PROFESSOR 
Affiliation  jss hospital 
Address  Department of anaesthesiology, Mahathma Gandhi road, Fort Mohalla, Ramachandra Agrahara.

Mysore
KARNATAKA
570004
India 
Phone  9986079823  
Fax    
Email  drsrinivashtjss@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Srinivas H T 
Designation  ASSOCIATE PROFESSOR 
Affiliation  jss hospital 
Address  Department of anaesthesiology, Mahathma Gandhi road, Fort Mohalla, Ramachandra Agrahara.

Udupi
KARNATAKA
570004
India 
Phone  09986079823  
Fax    
Email  drsrinivashtjss@gmail.com  
 
Source of Monetary or Material Support  
JSS Medical college and Hospital, Mysuru 
 
Primary Sponsor  
Name  Ragul D 
Address  Junior resident, Department of anesthesiology, JSS Hopsital 
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 
Ragul D  JSS Hospital  PAIN OT, 3RD FLOOR OT COMPLEX.
Mysore
KARNATAKA 
9566822442

raguldharmalingam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  RADIOFREQUENCY ABLATION  The duration of therapy is 10mins. The frequency is once. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1 LFJ related low back pain >3months
2 Ability to understand study protocol and able to provide voluntary written consent
3 Benefit in pain reduction atleast 50% after intraarticular diagnostic block
4 MRI proven LFJ osteoarthritis 
 
ExclusionCriteria 
Details  1 A lack of positive response after diagnostic block
2 History of osteoporosis, malignancy and trauma.
3 Allergic reaction to local anaesthetics.
4 Pregnancy or lactating
5 Lumbar spinal stenosis, vertebral fractures 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
pain relief  at Baseline,1 month and at 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
quality of life  at baseline, 1 month and 6 months 
 
Target Sample Size   Total Sample Size="17"
Sample Size from India="17" 
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)   30/11/2022 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

A thorough pre anaesthetic evaluation will be done 24 hours prior to the procedure. All patients will be assigned to LFJ intraarticular PRP injection or RFA of medial branch nerve. The evaluation of the enrolled patients will be done by experienced Orthopedician and the diagnosis will be based on physical examination, radio imaging (MRI) and diagnostic block of L3/L4-L5/S1 LFJ with 0.5% Bupivacaine.  Standard monitoring with electrocardiography (ECG), automated NIBP (noninvasive blood pressure), and pulse oximetry (SpO2) will be done for intraoperative monitoring.

Randomization of the participants into two groups id done by using sealed shuffled opaque envelope technique.

 

Participants will be divided into two groups:-

GROUP 1:-Those who are receiving intraarticular PRP injections

GROUP 2:- Those who are receiving RFA of medial branch nerve

 

This will be a double blinded study. In both groups, all procedures will be performed by the same experienced pain physician. The only unblinded personnel in this study is the primary pain physician. Patients will be unblinded after the 6 months follow up or if requested before that time.

 

Intraarticular Diagnostic blocks:

Patients in prone position, under fluoroscopy and under strict aseptic conditions, a 22G needle is inserted until it is contacted at the edge of the LFJ. Adequate needle positioning is confirmed by injecting 0.3 to 0.5ml of contrast. Once position is confirmed, 1ml of 0.5% bupivacaine is injected into LFJ.

 

Radiofrequency Denervation:

All RFA procedures are performed under fluoroscopic guidance. Patients in prone position, under aseptic conditions, 20G curved 100mm RF needles with active tips are placed at the site of the dorsal ramus medial branch of the relevant L3/L4-L5/S1 LFJ’s. Correct placement is confirmed using electrostimulation at 50 HZ for sensory and 2HZ for motor functions. Then 0.5% bupivacaine is injected through cannula to decrease procedure related pain. The RF probe is then reinserted into the cannula and lesioning at a temperature of 80℃ for 90 seconds using RF generator. Then, inj.dexamethasone 4mg is injected to prevent post operative neuritis.

 
Close