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Epidural Pulsed Radiofrequency Treatment in Failed Back Surgery Syndrome

NCT06239857 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-02-02

No results posted yet for this study

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

  • Back Pain
  • Failed Back Surgery Syndrome
  • Neuropathic Pain

Interventions

PROCEDURE

Epidural pulsed radiofrequency

The 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.

Sponsors & Collaborators

  • Başakşehir Çam & Sakura City Hospital

    lead OTHER_GOV

Principal Investigators

  • Günay Yolcu, MD · Başakşehir Çam & Sakura City Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2024-06-15
Completion
2024-07-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06239857 on ClinicalTrials.gov