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Completed

NCT Number: NCT05713032

Pulsed Radiofrequency 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Research Institute

Alexandria, Al, 1234, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Pulsed radiofrequency on lumbar dorsal root ganglion

Procedure

voltage of pulsed radiofrequency on DRG

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

Other outcomes

  1. Record of Complications intra or post-intervention

    Time frame: 6 months

    as infection (eg; Epidural abscess , diskitis ) , bleeding , dural puncture and nerve injury

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2023
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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