Pulsed Radiofrequency Treatment in Lumbar Facet-Related Pain

Comparison of the Treatment Outcomes of the Facet Intra-articular Pulsed Radiofrequency and Median Branch Pulsed Radiofrequency Interventions in Lumbar Facet-related Pain

Facet joint-related pain is one of the leading causes of low back pain. Facet joint-related disorders can have a negative impact on quality of life and daily living activities, in addition to the pain.Conservative treatment methods such as analgesic medications, physical therapy, and manual therapy are used for facet joint-related low back pain, and interventional pain management practices are used in patients who do not respond adequately to these treatments.

Pulse radiofrequency application, which is a recent popular treatment in interventional pain management, is also frequently applied in the treatment of facet-joint related pain. Pulsed radiofrequency intervention can be applied directly intra-articularly or can be applied to the median branch, which is important structure in pain transmission. Although both methods are frequently used in pain management, there is a lack of information in the literature about which is more effective. This study aimed to compare the treatment results of intraarticular pulse radiofrequency application and median branch pulse radiofrequency application in facet joint-related low back pain.

Study Overview

• Status: Completed
• Conditions: Pain, Chronic; Facet Joint Pain; Pain Syndrome
• Intervention / Treatment: Procedure: Intra-articular pulsed radiofrequency; Procedure: Median branch pulsed radiofrequency

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34488
    • Basahsehir Cam and Sakura City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Having facet joint-related low back pain at least 3 months
• No response to other conservative treatments (analgesic medications, physical therapy, manuel therapy etc.)
• Patients with a pain severity score of at least 6 according to NRS

Exclusion Criteria:

• History of lumbar region surgery
• Patients with bleeding disorders
• Presence of pregnancy and breastfeeding status
• Presence of the infection related findings and any other systemic disorder
• History of allergic reaction to contrast agent
• Patients who do not have sufficient mental function to fill out the scales during the follow-up periods

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intra-articular pulsed radiofrequency group; This arm consists of patients who received intra-articular pulse radiofrequency treatment.	Procedure: Intra-articular pulsed radiofrequency; Intra-articular pulsed radiofrequency procedures for the treatment of facet joint-related low back pain are performed under sterile conditions in the operating room. The application is performed under fluoroscopy guidance using a 20 gauge 10 mm active tip radiofrequency needle. When the intra-articular joint, which is the target tissue, is reached with the help of fluoroscopy images, pulse radiofrequency treatment will be applied with the parameters being maximum temperature 42 degrees, 45 volts, duration 6 minutes, pulse rate 2 hertz and pulse width 20 milliseconds.
Active Comparator: Median branch pulsed radiofrequency group; This arm consists of patients who received median branch pulse radiofrequency treatment.	Procedure: Median branch pulsed radiofrequency; Median branch pulsed radiofrequency procedures for the treatment of facet joint-related low back pain are performed under sterile conditions in the operating room. The application is performed under fluoroscopy guidance using a 20 gauge 10 mm active tip radiofrequency needle. When the median branch region, which is the target area, is reached with the help of fluoroscopy images, location confirmation will be provided by giving sensory and motor stimulation. Pulse radiofrequency treatment will be applied with the parameters being maximum temperature 42 degrees, 45 volts, duration 6 minutes, pulse rate 2 hertz and pulse width 20 milliseconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the pain severity score	Pain severity is assessed by using "Numeric Rating Scale" (NRS). Patients give score of their pain between 0 (no pain) and 10 (worst possible pain). The change in NRS scores between the two groups will be compared.	Pre-intervention, post-intervention 1th month and post-intervention 6th month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the disability score	Disability conditions of the patients are assessed by using "Oswestry Disability Index" (ODI). ODI is a patient-completed questionnaire which gives a percentage score of disability. The ODI is comprised of 10 items and enquires about functional limitations in various activities of daily living with the index score ranging from 1 (best) to 100 (worst). The change in ODI scores between the two groups will be compared.	Pre-intervention, post-intervention 1th month and post-intervention 6th month

Collaborators and Investigators

• Sponsor: Basaksehir Cam & Sakura Şehir Hospital
• Investigators: Principal Investigator: Burak Erken, MD, Basaksehir Cam & Sakura Şehir Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): November 27, 2023

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): December 5, 2023

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Chronic Pain
• Other Study ID Numbers: 2021.05.102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No