Ultrastructural changes in axons following exposure to pulsed radiofrequency fields.
Serdar Erdine, Ayhan Bilir, Eric R Cosman...
https://pubmed.ncbi.nlm.nih.gov/19761513Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06264297
High-Voltage Pulsed Radiofrequency of the Lumbar Dorsal Root Ganglion for Treatment of Chronic Lumbar Radicular and Neuropathic Pain; A Prospective, Double-Blinded, Randomized Controlled Trial
Led by Consorci Sanitari de Terrassa · Updated on 2024-02-16
98
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
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
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 1 location
1
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain, 08227
Actively Recruiting
Loading map...
Research Team
M
Maria Martinez
M
Maria Martinez
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This 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...
https://pubmed.ncbi.nlm.nih.gov/28540817Electric and thermal field effects in tissue around radiofrequency electrodes.
Eric R Cosman, Eric R Cosman
https://pubmed.ncbi.nlm.nih.gov/16336478A History of the Development of Radiofrequency Neurotomy.
Marc Russo, Danielle Santarelli, Robert Wright...
https://pubmed.ncbi.nlm.nih.gov/34992451Pulsed radiofrequency in lumbar radicular pain: clinical effects in various etiological groups.
David Abejón, Santiago Garcia-del-Valle, María Lorenza Fuentes...
https://pubmed.ncbi.nlm.nih.gov/17305674Pulsed radiofrequency: a review of the basic science as applied to the pathophysiology of radicular pain: a call for clinical translation.
Koen Van Boxem, Marc Huntoon, Jan Van Zundert...
https://pubmed.ncbi.nlm.nih.gov/24553305Electrocatheter-mediated High-voltage Pulsed Radiofrequency of the Dorsal Root Ganglion in the Treatment of Chronic Lumbosacral Neuropathic Pain: A Randomized Controlled Study.
Simone Vigneri, Gianfranco Sindaco, Marco La Grua...
https://pubmed.ncbi.nlm.nih.gov/31577546Pulsed radiofrequency treatment adjacent to the lumbar dorsal root ganglion for the management of lumbosacral radicular syndrome: a clinical audit.
Koen Van Boxem, Joselien van Bilsen, Nelleke de Meij...
https://pubmed.ncbi.nlm.nih.gov/21812907The effect of combined pulsed radiofrequency treatment to dorsal root ganglion with transforaminal epidural steroid injection on pain.
Duygu Karaköse Çalışkan, Selcan Akesen, Yunus Gürkan Türker...
https://pubmed.ncbi.nlm.nih.gov/34671961Efficacy and Safety of Pulsed Radiofrequency as a Method of Dorsal Root Ganglia Stimulation in Patients with Neuropathic Pain: A Systematic Review.
Ivana Vuka, Tihana Marciuš, Svjetlana Došenović...
https://pubmed.ncbi.nlm.nih.gov/32488240