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NCT Number: NCT06695481

Radiofrequency Treatments for Lumbar Facet Joint Pain Management

In this study, investigators compared the effectiveness of medial branch conventional radiofrequency application and combined radiofrequency application in patients with lumbar facet joint disease , focusing on pain scores. The combined radiofrequency application, a sequence of pulsed radiofrequency and conventional radiofrequency , has been shown to be successful in treating neck pain and headache. These findings are of significant importance in the field of pain management and spinal disorders.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Zygapophyseal Joint Arthritis

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, Çankaya, 06230, Turkey (Türkiye)

About this study

The treatment of chronic pain using pulsed radiofrequency (RF) has not shown any significant side effects. As a result, a combined approach of using both pulsed and conventional RF treatment in the same session has been assumed since the 2010s. This combined RF method is still widely used for pain management. The aim of this study is to compare the effectiveness of conventional RF with the combined RF method as a medial branch RF method for the management of lumbar facet joint pain.The study involved patients who had undergone medial branch denervation for lumbar facet joint pain and had medical records available. This study was conducted retrospectively by examining the study data. Patients with missing data were excluded from the study.

Patients underwent a fluoroscopy-guided selective medial branch nerve block using 2% lidocaine 0.5ml before treatment. After 30 minutes, they were asked if there was a 50% reduction in pain intensity.The conventional RF group consists of patients who received medial branch RF with a duration of 2 minutes, at 80̊ C temperature, and 7 Volts. In the combined RF group, treatment was initiated first with a conventional RF duration of 2 minutes at a temperature of 80̊ C at 7 Volts. Then, pulsed RF duration was applied for 6 minutes at a temperature of 42 C at 45 Volts, with a pulse frequency of 2 Hz and a width of 20 ms.After procedure In the outpatient clinic, experienced pain specialists recorded NRS (Numeric Rating Scale) and DN4 (Douleur Neuropathic 4 Questions) scores at the 6th and 12th-month follow-up appointments after the procedure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 40 - 90 years of age
  • Patients with low back pain for more than three months and did not respond to conservative treatment

Exclusion criteria

  • Patients who underwent facet joint medial branch RF treatment previously
  • Patients had additional interventional pain treatment or lumbar surgery within one year of the procedure
  • Patients had radicular and significant disc pathology, psychiatric diseases or mental problems, malignancies
  • Patients of one year follow-up could not be assessed entirely in the system

Treatment and study plan

Conventional RF

Procedure

The conventional RF group consists of patients who received medial branch RF with a duration of 2 minutes, at 80̊ C temperature, and 7 Volts.

Combined RF

Procedure

In the combined RF group, treatment was initiated first with a conventional RF duration of 2 minutes at a temperature of 80̊ C at 7 Volts. Then, pulsed RF duration was applied for 6 minutes at a temperature of 42 C at 45 Volts, with a pulse frequency of 2 Hz and a width of 20 ms.

Primary outcomes

  1. Neuropathic Pain Scale

    Time frame: Scores of the patients ; before the procedure and 6 and 12 months after the procedure are shownThe 7 symptoms items are scored by interviewing the patient.The scores are added and a score of 4 or more out of ,10 point (severe pain ) .

    Neuropathic Pain 4 Questions (DN4)

  2. Pain Rating Scale

    Time frame: The NRS scores of the patients before the procedure and 6 and 12 months after the procedure .NRS in which individuals rate their pain on an ten-point numerical scale. Zero:''no pain at all' ten-point ''severe pain''

    Numeric Rating Scale

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Comparison of Combined Versus Conventional Radiofrequency Thermocoagulation for Lumbar Facet Joint Pain Management: A Retrospective Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 19, 2024
Registry last updated
Nov 19, 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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