Epidural Pulsed Radiofrequency Treatment in Failed Back Surgery Syndrome

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06239857
• Other study ID #: 27.12.2023.700
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: July 30, 2024

Study information

• Verified date: January 2024
• Source: Basaksehir Cam & Sakura Sehir Hospital
• Contact: Burak Erken, MD
• Phone: +902129096000
• Email: burak_erken[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: July 30, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Failed Back Surgery Syndrome
• Neuralgia
• Neuropathic Pain
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Basaksehir Cam & Sakura Sehir Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)