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 (Radiofrequency)

February 12, 2024 updated by: Maria Martinez, Consorci Sanitari de Terrassa
The management of chronic lumbar radicular and neuropathic pain is complex and the treatment success rates are low. Pulsed radiofrequency (PRF) has been described in these cases. In order to determine whether high-voltage PRF show better results than PRF a prospective, doble-blinded and randomized study is conducted in patients with chronic lumbar radicular and neuropathic pain.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients over 18 years of age.
  • Unilateral pain radiating to the lower extremity (with or without lumbar pain), which clinically corresponds to the path of the corresponding dermatomes.
  • Correlation between clinical symptoms and lesion observed by magnetic resonance imaging (MRI).
  • Radicular syndrome of three months or more of evolution.
  • Normal or pathological electromyogram (EMG).
  • Pain with neuropathic characteristics confirmed by the DN4 neuropathic pain questionnaire.
  • Patients with a previous positive block diagnosis.
  • Patients who have signed the informed consent document.

Exclusion Criteria:

  • Patients under 18 years of age.
  • Patients with non-radicular low back pain.
  • MRI not consistent with the patient's symptoms.
  • Patients with peripheral neuropathy of the lower extremities.
  • Patients with a history or current diagnosis of serious mental disorder.
  • Patients with moderate or severe cognitive impairment, or evidence of acute or subacute confusional syndrome.
  • Infection at the puncture site.
  • Coagulation disorders.
  • Pregnant patients.
  • Patients who refuse to sign the informed consent document.
  • Patients allergic to radiological contrast.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GROUP I
RFP on the affected level or levels will be carried out during three cycles of 120 s, limited to a temperature of 42° and a voltage of 45V
Procedure: Radiofrequency
Pulsed radiofrequency (PRF) is a nonablative pain treatment that uses radiofrequency current in short high-voltage bursts, resulting in interruption of nociceptive afferent pathways. This study aims to show how the variation in radiofrequency voltage applied to the dorsal root ganglion (DRG) affects the treatment of neuropathic pain.
Experimental: GROUP II
RFP on the affected level or levels will be carried out during three cycles of 120 s, limited to a temperature of 42° and a voltage of 65V
Procedure: Radiofrequency
Pulsed radiofrequency (PRF) is a nonablative pain treatment that uses radiofrequency current in short high-voltage bursts, resulting in interruption of nociceptive afferent pathways. This study aims to show how the variation in radiofrequency voltage applied to the dorsal root ganglion (DRG) affects the treatment of neuropathic pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSWESTRY LOW BACK DISABILITY QUESTIONNAIRE
Time Frame: From enrollment to the end of treatment at 6 months
this questionnaire has been designed to give us information as to how your back pain has affected your ability to manage everyday life
From enrollment to the end of treatment at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DN4 - QUESTIONNAIRE
Time Frame: From enrollment to the end of treatment at 6 months
DN4 - QUESTIONNAIRE To estimate the probability of neuropathic pain, please answer yes or no for each item of the following four questions.
From enrollment to the end of treatment at 6 months
Visual Numeric Scale
Time Frame: From enrollment to the end of treatment at 6 months
ranging from 0 to 10 was used to measure pain intensity
From enrollment to the end of treatment at 6 months
Categorical scale
Time Frame: From enrollment to the end of treatment at 6 months
uses adjectives, such as "mild," "moderate," "severe," and excruciating," to describe pain levels.
From enrollment to the end of treatment at 6 months
patient global impression of improvement (pgi-i) score
Time Frame: From enrollment to the end of treatment at 6 months
is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment
From enrollment to the end of treatment at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci Sanitari de Terrassa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-22-270-111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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