| 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
|
|
|
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
|
|
|
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. |