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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

ConditionsPulsed RadiofrequencyLumbar Radiculopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorConsorci Sanitari de Terrassa

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiofrequency

    Procedure/Surgery

    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.

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: GROUP IActive comparator 1 intervention
Group B: GROUP IIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

OSWESTRY LOW BACK DISABILITY QUESTIONNAIRE

this questionnaire has been designed to give us information as to how your back pain has affected your ability to manage everyday life

Time frame
From enrollment to the end of treatment at 6 months

Secondary outcomes

1

DN4 - QUESTIONNAIRE

DN4 - QUESTIONNAIRE To estimate the probability of neuropathic pain, please answer yes or no for each item of the following four questions.

Time frame
From enrollment to the end of treatment at 6 months
2

Visual Numeric Scale

ranging from 0 to 10 was used to measure pain intensity

Time frame
From enrollment to the end of treatment at 6 months
3

Categorical scale

uses adjectives, such as "mild," "moderate," "severe," and excruciating," to describe pain levels.

Time frame
From enrollment to the end of treatment at 6 months
4

patient global impression of improvement (pgi-i) score

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

Time frame
From enrollment to the end of treatment at 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Consorci Sanitari de Terrassa

Lead sponsor

Source ClinicalTrials.gov
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