A Randomized, Double-Blind Study Comparing High-Voltage and Standard Pulsed Radiofrequency
Treatment for Chronic Lumbar Radicular and Neuropathic Pain
Led by Consorci Sanitari de Terrassa · Updated on 2024-02-16
98
Participants Needed
1
Research Sites
47 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying chronic lumbar radicular and neuropathic pain, which are difficult to manage and often have low success rates with treatment. This trial compares the effects of high-voltage pulsed radiofrequency PRF to standard PRF on the lumbar dorsal root ganglion to see which method provides better pain relief. The study is designed as a prospective, double-blinded, randomized controlled trial conducted by Consorci Sanitari de Terrassa.
Participants will receive PRF treatment on the affected lumbar levels in two different groups one receiving PRF at 45 volts and the other at 65 volts. Both treatments involve three cycles of 120 seconds each, with a temperature limit of 42 degrees Celsius. The trial evaluates how varying the voltage affects neuropathic pain by targeting the dorsal root ganglion.
During the study, participants will be assessed using the Oswestry Low Back Disability Questionnaire over six months to measure disability related to back pain. Additional evaluations include the DN4 neuropathic pain questionnaire, Visual Numeric Scale, categorical pain scales, and patient global impression of improvement scores. The trial is randomized and triple-blinded to ensure unbiased results, and participants will be monitored from enrollment through the six-month treatment period.
CONDITIONS
Brief Title
High-Voltage Pulsed Radiofrequency of the Lumbar Dorsal Root Ganglion for the Treatment of Chronic Lumbar Radicular and Neuropathic Pain; A Prospective, Doble-blinded and Randomized Controlled Trial
Research Team
M
Maria Martinez
M
Maria Martinez
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Unilateral pain radiating to the lower extremity, with or without lumbar pain, matching the path of the corresponding dermatomes
Clinical symptoms correlate with lesion shown by magnetic resonance imaging (MRI)
Radicular syndrome lasting three months or more
Normal or pathological electromyogram (EMG)
Neuropathic pain confirmed by DN4 neuropathic pain questionnaire
Previous positive block diagnosis
Signed informed consent document
You will not qualify if you...
Patients under 18 years of age
Non-radicular low back pain
MRI findings not consistent with patient symptoms
Peripheral neuropathy of the lower extremities
History or current diagnosis of serious mental disorder
Moderate or severe cognitive impairment, or acute/subacute confusional syndrome
Infection at puncture site
Coagulation disorders
Pregnant patients
Refusal to sign informed consent document
Allergy to radiological contrast
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 6 months
Participants receive pulsed radiofrequency treatment applied to the lumbar dorsal root ganglion at either 45V or 65V during three cycles of 120 seconds each to treat chronic lumbar radicular and neuropathic pain.
1 treatment visit and follow-up visits during the 6-month treatment period
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Electrocatheter-mediated High-voltage Pulsed Radiofrequency of the Dorsal Root Ganglion in the Treatment of Chronic Lumbosacral Neuropathic Pain: A Randomized Controlled Study.
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Transforaminal Epidural Injection of Local Anesthetic and Dorsal Root Ganglion Pulsed Radiofrequency Treatment in Lumbar Radicular Pain: A Randomized, Triple-Blind, Active-Control Trial.
Effect of applied voltage, duration and repetition frequency of RF pulses for pain relief on temperature spikes and electrical field: a computer modelling study.
Elżbieta Ewertowska, Borja Mercadal, Víctor Muñoz...