Pulsed Radiofrequency in Chronic Lumbosacral Radicular Pain

Study Overview
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Brief Summary
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To evaluate the efficacy of usage of High-voltage pulsed radiofrequency on DRG in comparison to standard-voltage pulsed radiofrequency intervention in patients with chronic lumbosacral radicular pain

Detailed Description
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Lumbosacral radicular (LRS) pain is one of the most common health care problem. Up to 5% of the population older than 30 years of age suffer low back pain radiating into the leg, making it probably the most commonly occurring form of neuropathic pain. Radicular pain has been discerned as the pain arising in a limb or trunk which is caused by ectopic activation of nociceptive afferent fibers in a spinal nerve or its roots or other neuropathic mechanisms. More accurately, radicular pain is a term applied to describe pain that results from the stimulation of, or a disorder of, a nerve root. Acute lumbosacral radicular pain, caused by disc herniation, improves considerably in the short-term. About three quarters of patients will have symptoms of recovery within 3 months; however, there is a high recurrence rate, and when pain persists after this period the prognosis is rather unfavorable, especially in the female population. Conservative therapy (pharmacotherapy or physiotherapy) is effective in 60% of cases, while the rest of cases progress into chronic pain. This results in a high degree of disability and ending with higher medical expenses. Patients suffering lumbosacral radicular pain often experience a reduced functionality leading to incapacity to work. A quarter of patients are still out of work 2 years after onset. Despite its high prevalence and significant impact on quality of life, the optimal conservative treatment for patients with radicular pain is not known. Considering the moderate quality of published evidence, the efficacy and tolerability of pharmacological treatment in primary care for patients with lumbosacral radicular pain is unclear. In the DRG, there is a process that takes place after being compressed by disc prolapse where a cascade of events within the DRG and upstream within the dorsal horn (DH) of the spinal cord leads to constitutive release of cytokines, production of abnormal ion channels, abnormal ion currents, early and late gene changes, and the development of chronic neuropathic pain. With this knowledge regarding the role of DRG neurons and non-neuronal cells within the DRG in the genesis of neuropathic pain, pharmacologic agents such as tetrodotoxin and non-pharmacologic treatments for neuropathic pain including electrical stimulation (neuromodulation) therapies targeting the DRG have been or are being developed. Pulsed radiofrequency (PRF) is a therapeutic strategy that has been used by pain practitioners as a non- or minimally autodestructive technique in which short bursts of high-frequency current are applied to nervous tissue. PRF is delivered in a pulse of 20 ms followed by a silent period of 480 ms to avoid radiofrequency heat lesions, and Pulsed radiofrequency (PRF) treatment uses high-frequency current intermittently and its use adjacent to the dorsal root ganglion (DRG) has been suggested for the treatment of radicular pain. It was previously demonstrated in other studies that the therapeutic effectiveness of PRF is affected by its parameters and the high-voltage PRF has been promising to enhance the clinical therapeutic effectiveness significantly for patients with neuralgia

Official Title
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High-voltage Fluoroscopic Guided Pulsed Radiofrequency in Comparison With Standard-voltage Pulsed Radiofrequency on Dorsal Root Ganglion in Chronic Lumbosacral Radicular Pain

Conditions
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Lumbar Radiculopathy

Intervention / Treatment
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* Procedure: Pulsed radiofrequency on lumbar dorsal root ganglion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than 18 years old Radiating Leg pain (with or without low back pain) Unresponsiveness or partial response to oral medications, physical therapy Confirmed by clinical examination and lasting for > 6 months with preoperative Numeric Rating Scales (NRS) score more than 4 Clinical presentation confirmed by Magnetic resonance imaging showing neural compression. Exclusion Criteria: Blood coagulopathies Infection at the site of puncture, History of mental disorder History of drug abuse MRI not consistent with clinical symptoms Radiculopathies with significant motor deficits requiring urgent surgery (e.g., Cauda Equina syndrome). Patients affected by central neurological impairment or peripheral distal neuropathies in the lower limbs.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard voltage group<br>The Standard voltage group will be given a onetime pulsed radiofrequency (PRF) therapy. All subjects in this group will be given radiofrequency therapy on the dorsal root ganglion using the same tools and procedures by the same operator. Pulsed RF mode of RF generator will be used with following parameters --Temperature 42°C -- Frequency 2 Hertz - Pulse Width 20msec-Amplitude output voltage 45 Volt for Duration of 480sec done in 2 cycles. | Procedure: Pulsed radiofrequency on lumbar dorsal root ganglion<br>* voltage of pulsed radiofrequency on DRG<br>|
| Active Comparator: high voltage group<br>The High voltage group will be given a onetime pulsed radiofrequency (PRF) therapy. All subjects in this group will be given radiofrequency therapy on the dorsal root ganglion using the same tools and procedures by the same operator. Pulsed RF mode of RF generator will be used with following parameters --Temperature 42°C -- Frequency 2 Hertz - Pulse Width 20msec-Amplitude output voltage will be gradually increased to reach the highest voltage for each patient (55-75 Volt) for Duration of 480sec done in 2 cycles. | Procedure: Pulsed radiofrequency on lumbar dorsal root ganglion<br>* voltage of pulsed radiofrequency on DRG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric rating scale | Numeric scale used to evaluate pain severity with 0 as the lowest score (no pain at all) and 10 as the highest score (most serious pain beyond endurance) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry low back disability questionnaire | Questionnaire composed of ten questions and for each question, there is a possible points; 0 for the first answer, 1 for the second answer, etc. Score 0-4 : No disability Score 5-14 : Mild disability Score 15-24 : Moderate disability Score 25-34 : Severe disability Score 35-50 : Completely disabled | 6 months |