Pulsed Radiofrequency Treatment in Lumbar Facet-Related Pain
NCT ID: NCT06157294
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
116 participants
INTERVENTIONAL
2021-12-01
2023-11-27
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intra-articular pulsed radiofrequency group
This arm consists of patients who received intra-articular pulse radiofrequency treatment.
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 group
This arm consists of patients who received median branch pulse radiofrequency treatment.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Başakşehir Çam & Sakura City Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Burak Erken, MD
Role: PRINCIPAL_INVESTIGATOR
Başakşehir Çam & Sakura City Hospital
Locations
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Basahsehir Cam and Sakura City Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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2021.05.102
Identifier Type: -
Identifier Source: org_study_id