Epidural Pulsed Radiofrequency Treatment in Failed Back Surgery Syndrome

NCT06239857 | Unknown

• 1 other identifier: 27.12.2023.700
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Back Pain; Failed Back Surgery Syndrome; Neuropathic Pain

Outcome Measures

Primary Outcomes (10)

• Change in pain severity score

  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.

  A single point in time (pre-procedural time)

• Change in pain severity score

  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.

  A single point in time (post-procedural 1.month)

• Change in pain severity score

  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.

  A single point in time (post-procedural 3.month)

• Change in pain severity score

  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.

  A single point in time (post-procedural 6.month)

• Change in pain severity score

  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.

  A single point in time (post-procedural 12.month)

• Change in the number of patients with neuropathic pain

  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.

  A single point in time (pre-procedural time)

• Change in the number of patients with neuropathic pain

  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.

  A single point in time (post-procedural 1.month)

• Change in the number of patients with neuropathic pain

  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.

  A single point in time (post-procedural 3.month)

• Change in the number of patients with neuropathic pain

  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.

  A single point in time (post-procedural 6.month)

• Change in the number of patients with neuropathic pain

  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.

  A single point in time (post-procedural 12.month)

Study Arms (1)

Epidural pulsed radiofrequency treatment

EXPERIMENTAL

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

Procedure: Epidural pulsed radiofrequency

Interventions

Epidural pulsed radiofrequency 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.

Epidural pulsed radiofrequency treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Related Publications (1)

• Erken B, Yolcu G, Saracoglu TT. Efficacy of Epidural Pulsed Radiofrequency Treatment in Persistent Spinal Pain Syndrome: A Prospective Clinical Study. Pain Res Manag. 2025 Apr 11;2025:6200102. doi: 10.1155/prm/6200102. eCollection 2025.

  PMID: 40255928 DERIVED

MeSH Terms

Conditions

Back Pain; Failed Back Surgery Syndrome; Neuralgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Günay Yolcu, MD

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Burak Erken, MD

CONTACT

+902129096000; burak_erken@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 2, 2024
• Study Start: February 15, 2024
• Primary Completion: June 15, 2024
• Study Completion: July 30, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-01