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CTRI Number  CTRI/2016/02/006666 [Registered on: 19/02/2016] Trial Registered Prospectively
Last Modified On: 16/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Other (Specify) [Pulsed Radiofrequency Treatment]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to determine the efficacy of radiofrequency ablation (a method of management for long-standing low back pain). 
Scientific Title of Study   Transforaminal Epidural Injection of Local Anesthetic and Dorsal Root Ganglion Pulsed Radiofrequency Treatment in Lumbosacral Radicular Pain- A Randomized, Triple-Blind, Active-Control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manish De 
Designation  Junior Resident (Post-graduate trainee) 
Affiliation  All India Institute of Medical Sciences 
Address  AIIMS, Main OT complex, Main Block, 8th Floor, Ansari Nagar East

South
DELHI
110029
India 
Phone  8527698998  
Fax    
Email  manish18y@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Virender Kumar Mohan 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  AIIMS, 5th Floor, Department of Anesthesiology, Pain Medicine & Critical Care

South
DELHI
110029
India 
Phone  9891557705  
Fax    
Email  dr_vkmohan@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Virender Kumar Mohan 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  AIIMS, 5th Floor, Department of Anesthesiology, Pain Medicine & Critical Care

West
DELHI
110029
India 
Phone  9891557705  
Fax    
Email  dr_vkmohan@yahoo.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  Main OT complex, Wards Block, AB-8th Floor, AIIMS, Ansari Nagar East, New Delhi- 110029 
Type of Sponsor  Government medical college 
 
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 
Manish De  Pain OT, 8th floor, Wards Block-AB, All India Institute of Medical Sciences, New Delhi  Main OT complex, Wards Block, AB-8th Floor, AIIMS, Ansari Nagar East, Delhi- 110029
South
DELHI 
8527698998

manish18y@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committe, All India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Adult patients with a history of segmental low back pain of more than 3 months duration, refractory to conventional physiotherpy and analgesics with predominant leg pain over back pain.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pulsed Radiofrequency ablation  After attaching the standard monitors and securing iv access, the patient is made prone. Under all aseptic precautions, 2% preservative-free lignoaine is infiltrated in the skin entry site of designated level determined by both clinical and radiographic evidence of radicular pain. A 10 cm, 22 gauge radiofrequency cannula will be inserted under fluoroscopic guidance. After confirming the final needle position by both AP and lateral view, 0.5 ml of contrast agent will be injected. Once the position of the needle tip is confirmed in the postero-superior quadrant of the intervertebral foramina, the stylet will be removed and replaced by RF probe connected to the RF generator. Final position of the tip of needle (just at the level of DRG) will be confirmed by appropriate sensory stimulation with 50 Hz with 0.4-0.6 V and motor stimulation is done at 2 Hz to determine a threshold of 1.5-2 times greater than sensory threshold (0.8 V) to avoid placement of the needle near the anterior nerve root. Impedance will be checked to ensure a complete electrical circuit with a range of 200-400 Ohms. In these patients, 1 ml of Bupivacaine 0.5% will be injected and pulsed radiofrequency will be applied for a period of 120seconds at a frequency of 2 Hz at amplitude of 45V and needle tip temperature of 40-420 C. The RF machine will be put to silent mode and music will be played to mask any noise during the procedure thus making the patient blind to the procedure.  
Comparator Agent  Transforaminal epidural local anesthetic  After attaching the standard monitors and securing iv access, the patient is made prone. Under all aseptic precautions, 2% preservative-free lignoaine is infiltrated in the skin entry site of designated level determined by both clinical and radiographic evidence of radicular pain. A 10 cm, 22 gauge radiofrequency cannula will be inserted under fluoroscopic guidance. After confirming the final needle position by both AP and lateral view, 0.5 ml of contrast agent will be injected. Once the position of the needle tip is confirmed in the postero-superior quadrant of the intervertebral foramina, the stylet will be removed and replaced by RF probe connected to the RF generator. Final position of the tip of needle (just at the level of DRG) will be confirmed by appropriate sensory stimulation with 50 Hz with 0.4-0.6 V and motor stimulation is done at 2 Hz to determine a threshold of 1.5-2 times greater than sensory threshold (0.8 V) to avoid placement of the needle near the anterior nerve root. Impedance will be checked to ensure a complete electrical circuit with a range of 200-400 Ohms. In these patients, 1 ml of Bupivacaine 0.5% will be injected. The RF machine will be put to silent mode and music will be played to mask any noise during the procedure thus making the patient blind to the procedure.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • History of segmental low back pain of lumbar or sacral origin with radiation to legs below knee of more than 3 months duration, refractory to conventional physiotherpy and analgesics.
• History of predominant leg pain over back pain.
• Pain involving up to two lumbar levels.
• Average pain score of ≥5 on a 11-point NRS.
• Computed tomography/Magnetic resonance imaging evidence of nerve root pain concordant with the side and level of clinical features.
• Informed consent.
• No significant compression of dural sac or nerve root.
 
 
ExclusionCriteria 
Details  • Patient refusal to participate.
• Coagulopathy and/or patients on anticoagulants.
• Infection at the site of injection.
• Hypersensitivity to local anesthetic and/or radiographic contrast agent.
• Evidence of significant sensory or motor deficit.
• Presence of anatomical deformity of spine e.g. scoliosis, kyphosis etc.
• Evidence of severe psychiatric illness.
• Presence of cancer as a cause of back pain.
• Inability to communicate in Hindi/English.
• History of previous back surgery or implant insertion.
• Presence of diabetes mellitus, multiple sclerosis, cardiac pacemaker, pregnancy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
• ≥50% or ≥4 point reduction in an 11-point numeric scale (NRS 11)
• ≥50% or ≥6 points reduction in GPE (Global Perceived Effect)  
2 weeks,1 month, 2 months, 3 months and 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
• Mean NRS (Numerical Rating Scale) and improvement in functional status as measured by Modified Oswestry Disability Questionnaire (MODQ) at respective time intervals.
• Employment status.
• Analgesic intake. 
2 weeks, 1 month, 2 months, 3 months and 6 months. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/03/2016 
Date of Study Completion (India) 31/08/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/08/2017 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Low back pain is a very common health hazard. It has added to the economic burden of the world due to not only the usage of health resources but also absenteeism from work. Lumbar radicular pain is one of most common causes of low back pain. The primary modalities of treatment such as oral drug therapy in the form of analgesics and anticonvulsants and physical exercise are associated with poor compliance and increased side-effects. Thus, the role of interventions has come to effect with immediate and long term pain relief. We have compared the efficacy of epidural injections of local anaesthetics and dorsal root ganglion pulsed radiofrequency treatment in the management of lumbar radicular pain.

Pre-enrollment evaluation:

The pain physician posted in the Pain Clinic will take demographic data and a detailed history about the low back pain. After physical examination, pain scores in terms of NRS and functional status according to MODQ will be noted in the Pain Clinic at AIIMS. MRI and/or CT studies will be taken into consideration to correlate with the clinical findings and level of intervention will be decided. Every patient will receive fluoroscopic guided diagnostic selective nerve root blockade with 1ml of 1% lidocaine and if positive response is seen to selective nerve block, they will be recruited for the study group.

Intervention:

After attaching the standard monitors and securing iv access, the patient is made prone. Under all aseptic precautions, 2% preservative-free lignoaine is infiltrated in the skin entry site of designated level determined by both clinical and radiographic evidence of radicular pain. A 10 cm, 22 gauge radiofrequency cannula will be inserted under fluoroscopic guidance. After confirming the final needle position by both AP and lateral view, 0.5 ml of contrast agent will be injected. Once the position of the needle tip is confirmed in the postero-superior quadrant of the intervertebral foramina, the stylet will be removed and replaced by RF probe connected to the RF generator. Final position of the tip of needle (just at the level of DRG) will be confirmed by appropriate sensory stimulation with 50 Hz with 0.4-0.6 V and motor stimulation is done at 2 Hz to determine a threshold of 1.5-2 times greater than sensory threshold (<0.8 V) to avoid placement of the needle near the anterior nerve root. Impedance will be checked to ensure a complete electrical circuit with a range of 200-400 Ohms.

Now, the technician operating the radiofrequency machine will open the sealed opaque envelope containing randomly allocated number. Accordingly, the procedure will be managed as below-

Group LA: 1 ml of Bupivacaine 0.5% will be injected

Group LPRF: 1 ml of Bupivacaine 0.5% will be injected and pulsed radiofrequency will be applied for a period of 120seconds at a frequency of 2 Hz at amplitude of 45V and needle tip temperature of 40-420 C.

The RF machine will be put to silent mode and music will be played to mask any noise during the procedure thus making the patient blind to the procedure.

Post procedure evaluation:

All patients will be observed in the recovery room for one hour. A blinded assessor will follow the patient at 2 weeks, 1, 2, 3 and 6 months post procedure recording NRS, GPE and MODQ score along with employment status and analgesic (opioids and/or NSAIDs) intake.

 
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