Epidural Pulsed Radiofrequency Treatment in Failed Back Surgery Syndrome

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2024-07-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Back Pain Failed Back Surgery Syndrome Neuropathic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Epidural pulsed radiofrequency treatment

All patients diagnosed with failed back surgery syndrome will receive epidural pulsed radiofrequency treatment.

Group Type EXPERIMENTAL

Epidural pulsed radiofrequency

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Being between the ages of 18-80
* History of at least one operation due to lumbar disc herniation
* Having radicular pain radiating to the lower extremities

Exclusion Criteria

* Having undergone surgery for an etiology other than lumbar disc herniation
* Accompanying spinal stenosis and spondylolisthesis
* Presence of fracture, infection, coagulopathy and pregnancy
* Mental disorders that may negatively affect cooperation during assessments.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes