Radiofrequency Treatments for Lumbar Facet Joint Pain Management

NCT ID: NCT06695481

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 133 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2023-10-01

Brief Summary

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.

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.

Conditions

Low Back Pain; Zygapophyseal Joint Arthritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Conventional RF

Intervention Type: 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

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.

Combined RF

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Tugce Yavuz

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nalan Celebi, Professor

Role: STUDY_DIRECTOR

Hacettepe University

Tuğçe Yavuz, M.D

Role: STUDY_CHAIR

Hacettepe University

Locations

Hacettepe University

Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Malaithong W, Munjupong S. Combined Continuous Radiofrequency Ablation and Pulsed Neuromodulation to Treat Cervical Facet Joint Pain and Alleviate Postcervical Radiofrequency Side Effects. Anesth Pain Med. 2022 Dec 14;12(6):e129747. doi: 10.5812/aapm-129747. eCollection 2022 Dec.

Reference Type: BACKGROUND

PMID: 36938106 (View on PubMed)

Ding Y, Li H, Hong T, Zhu Y, Yao P, Zhou G. Combination of Pulsed Radiofrequency with Continuous Radiofrequency Thermocoagulation at Low Temperature Improves Efficacy and Safety in V2/V3 Primary Trigeminal Neuralgia. Pain Physician. 2018 Sep;21(5):E545-E553.

Reference Type: BACKGROUND

PMID: 30282402 (View on PubMed)

Other Identifiers

2023/13-08

Identifier Type: -

Identifier Source: org_study_id