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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06157294
Enrollment
116
Registered
2023-12-05
Start date
2021-12-01
Completion date
2023-11-27
Last updated
2023-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facet Joint Pain, Pain Syndrome, Pain, Chronic

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.

Interventions

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.

PROCEDUREMedian 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.

Sponsors

Başakşehir Çam & Sakura City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of the pain severity scorePre-intervention, post-intervention 1th month and post-intervention 6th monthPain 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

MeasureTime frameDescription
Change of the disability scorePre-intervention, post-intervention 1th month and post-intervention 6th monthDisability 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026