Pulsed Radiofrequency Treatment in Lumbar Facet-Related Pain

Not Applicable

Completed

• Conditions: Facet Joint Pain; Pain, Chronic; Pain Syndrome
• Interventions: Procedure: Intra-articular pulsed radiofrequency; Procedure: Median branch pulsed radiofrequency

• Registration Number: NCT06157294
• Lead Sponsor: Başakşehir Çam & Sakura City Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Primary Completion: 2023-01-01
• Status Verified: 2023-11
• Study Completion: 2023-11-27
• Study First Submitted: 2023-11-27
• Study First Submitted QC: 2023-11-27
• Last Update Submitted: 2023-11-27
• Study First Posted: 2023-12-05
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-articular pulsed radiofrequency group	Intra-articular pulsed radiofrequency	This arm consists of patients who received intra-articular pulse radiofrequency treatment.
Median branch pulsed radiofrequency group	Median branch pulsed radiofrequency	This arm consists of patients who received median branch pulse radiofrequency treatment.

Primary Outcome Measures

Name	Time	Method
Change of the pain severity score	Pre-intervention, post-intervention 1th month and post-intervention 6th month	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.

Secondary Outcome Measures

Name	Time	Method
Change of the disability score	Pre-intervention, post-intervention 1th month and post-intervention 6th month	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.

Trial Locations

Locations (1)

Basahsehir Cam and Sakura City Hospital; 🇹🇷 Istanbul, Turkey