Pulsed Radiofrequency Treatment in Lumbar Facet-Related Pain

Pain, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06157294
• Other study ID #: 2021.05.102
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: November 27, 2023

Study information

• Verified date: November 2023
• Source: Basaksehir Cam & Sakura Sehir Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: November 27, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Chronic Pain
• Facet Joint Pain
• Pain Syndrome
• Pain, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Basahsehir Cam and Sakura City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Basaksehir Cam & Sakura Sehir Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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