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Completed

NCT Number: NCT06157294

Pulsed Radiofrequency Treatment in Lumbar Facet-Related Pain

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.

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Key information

Conditions

Facet Joint Pain Chronic Pain Mental Disorders Neurologic Manifestations Pain Pain Syndrome Pain, Chronic Pathological Conditions, Signs and Symptoms Signs and Symptoms Somatoform Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Basahsehir Cam and Sakura City Hospital

Istanbul, 34488, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change of the pain severity score

    Time frame: 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 outcomes

  1. Change of the disability score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 5, 2023
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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