Epidural Pulsed Radiofrequency Treatment in Failed Back Surgery Syndrome

Not Applicable

Not yet recruiting

• Conditions: Back Pain; Failed Back Surgery Syndrome; Neuropathic Pain
• Interventions: Procedure: Epidural pulsed radiofrequency

• Registration Number: NCT06239857
• Lead Sponsor: Başakşehir Çam & Sakura City Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-26
• Study First Submitted QC: 2024-01-26
• Last Update Submitted: 2024-01-26
• Study First Posted: 2024-02-02
• Last Update Posted: 2024-02-02
• Study Start: 2024-02-15
• Primary Completion: 2024-06-15
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epidural pulsed radiofrequency treatment	Epidural pulsed radiofrequency	All patients diagnosed with failed back surgery syndrome will receive epidural pulsed radiofrequency treatment.

Primary Outcome Measures

Name	Time	Method
Change in pain severity score	A single point in time (post-procedural 12.month)	Pain severity is evaluated by using Numerical Rating Scale (NRS). In evaluation, the patient scores the pain intensity between 0 (no pain) and 10 (worst pain). It is easy to apply and takes a short time.
Change in the number of patients with neuropathic pain	A single point in time (post-procedural 12.month)	The presence of neuropathic pain is assessed by Doleur Neuropathique-4 (DN-4) Questionnaire. It consists of two parts, including a physician examination part and a neuropathic pain related findings part in which the patients are questioned. A score above 4 indicates the presence of neuropathic pain.