Pulsed Radiofrequency Treatment in Lumbar Facet-Related Pain

NCT06157294 | Completed

• 1 other identifier: 2021.05.102
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Facet Joint Pain; Pain Syndrome; Pain, Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change of the disability score

  Pre-intervention, post-intervention 1th month and post-intervention 6th month

Study Arms (2)

Intra-articular pulsed radiofrequency group

ACTIVE COMPARATOR

This arm consists of patients who received intra-articular pulse radiofrequency treatment.

Procedure: Intra-articular pulsed radiofrequency

Median branch pulsed radiofrequency group

ACTIVE COMPARATOR

This arm consists of patients who received median branch pulse radiofrequency treatment.

Procedure: Median branch pulsed radiofrequency

Interventions

Intra-articular pulsed radiofrequency PROCEDURE

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.

Intra-articular pulsed radiofrequency group

Median branch pulsed radiofrequency PROCEDURE

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.

Median branch pulsed radiofrequency group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Basahsehir Cam and Sakura City Hospital

Istanbul, 34488, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Somatoform Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Burak Erken, MD

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 5, 2023
• Study Start: December 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: November 27, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-11

Locations

TU (1)