Radiofrequency Treatments for Lumbar Facet Joint Pain Management

November 18, 2024 updated by: Tugce Yavuz, Hacettepe University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

133

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

  • Turkey
    • Çankaya
      • Ankara, Çankaya, Turkey, 06230
        • Hacettepe University

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

Sampling Method

Non-Probability Sample

Study Population

Patients who are clinically diagnosed with lumbar facet joint pain after getting a pain reduction of over 50% following a selective diagnostic block (0.5 ml 2% lidocaine) performed on the facet joint medial branch block and after then RF (cobined or conventional) application under fluoroscopy.

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Conventional
In this group, only patients who had facet joint medial branch conventional RF applied to the patients who benefited after diagnostic injection into the facet joint were selected.
Procedure: Conventional RF
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
This group was selected retrospectively from patients who benefited from diagnostic injection into the facet joint and who underwent pulsed rf in addition to facet joint medial branch conventional rf.
Procedure: Combined RF
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 ) .
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
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''

Collaborators and Investigators

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

Sponsor

Hacettepe University

Investigators

  • Study Director: Nalan Celebi, Professor, Hacettepe University
  • Study Chair: Tuğçe Yavuz, M.D, Hacettepe University

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)

August 1, 2023

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

November 18, 2024

First Posted (Estimated)

November 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/13-08

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

product manufactured in and exported from the U.S.

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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