Pulsed Radiofrequency in Chronic Lumbosacral Radicular Pain

February 13, 2024 updated by: Mina Nabil Habib, Alexandria University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

96

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 Locations

  • Egypt
    • Al
      • Alexandria, Al, Egypt, 1234
        • Medical Research Institute

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. More than 18 years old
  2. Radiating Leg pain (with or without low back pain)
  3. Unresponsiveness or partial response to oral medications, physical therapy
  4. Confirmed by clinical examination and lasting for > 6 months with preoperative Numeric Rating Scales (NRS) score more than 4
  5. Clinical presentation confirmed by Magnetic resonance imaging showing neural compression.

Exclusion Criteria:

  1. Blood coagulopathies
  2. Infection at the site of puncture,
  3. History of mental disorder
  4. History of drug abuse
  5. MRI not consistent with clinical symptoms
  6. Radiculopathies with significant motor deficits requiring urgent surgery (e.g., Cauda Equina syndrome).
  7. Patients affected by central neurological impairment or peripheral distal neuropathies in the lower limbs.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard voltage group
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
voltage of pulsed radiofrequency on DRG
Active Comparator: high voltage group
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
voltage of pulsed radiofrequency on DRG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric rating scale
Time Frame: 6 months
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
Time Frame: 6 months

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Record of Complications intra or post-intervention
Time Frame: 6 months
as infection (eg; Epidural abscess , diskitis ) , bleeding , dural puncture and nerve injury
6 months

Collaborators and Investigators

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

Sponsor

Alexandria University

Investigators

  • Study Director: Sahar A Elkaradawy, professor, yes
  • Study Director: Mohamed H Ellakany, professor, yes

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 1, 2023

Primary Completion (Actual)

January 15, 2024

Study Completion (Actual)

February 14, 2024

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

February 2, 2023

First Posted (Actual)

February 6, 2023

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E/C. S/N. T124/2022

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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