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UnknownNCT06239857

Epidural Pulsed Radiofrequency Treatment in Failed Back Surgery Syndrome

Evaluation of the Effect of Epidural Pulsed Radiofrequency Treatment on Pain in Patients Diagnosed With Failed Back Surgery Syndrome (Persistant Spinal Pain Syndrome)

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
38 (estimated)
Sponsor
Başakşehir Çam & Sakura City Hospital · Other Government
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

Summary

Low back pain can persist in some patients with history of back surgery. In some cases, an increase in pain may even occur, and chronic pain may make treatment more difficult. A component of chronic pain is neuropathic pain, and its specific evaluation and treatment is important. Low back pain and radicular pain in the lower extremities are the main symptoms of failed back surgery syndrome (also called persistent spinal pain syndrome in new terminology). There are many methods for treatment of failed back surgery syndrome, such as analgesic medications, physical therapy, interventional pain treatment applications, and re-surgery options. Epidural pulsed radiofrequency therapy has recently become popular among interventional pain management procedures, and studies on its effectiveness are increasing. However, studies with a multifaceted approach that also evaluate neuropathic pain are lacking in the literature. In this study, it was planned to investigate the effect of epidural pulsed radiofrequency therapy on pain palliation, including neuropathic pain, in patients diagnosed with failed back surgery syndrome.

Conditions

Interventions

TypeNameDescription
PROCEDUREEpidural pulsed radiofrequencyThe radiofrequency treatment is applied under sterile conditions in the operating room environment. The target epidural area is reached under fluoroscopy guidance using a radiofrequency needle. After control of the needle position, radiofrequency treatment is given. Radiofrequency parameters are set as maximum temperature 42 degrees, 45 volts, duration 6 minutes, pulse rate 2 hertz and pulse width 20 milliseconds.

Timeline

Start date
2024-02-15
Primary completion
2024-06-15
Completion
2024-07-30
First posted
2024-02-02
Last updated
2024-02-02

Source: ClinicalTrials.gov record NCT06239857. Inclusion in this directory is not an endorsement.