Clinical trial NCT06239857: Epidural Pulsed Radiofrequency Treatment in Failed Back Surgery Syndrome
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Back Pain
Failed Back Surgery Syndrome
Neuropathic Pain
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-02-02
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in pain severity score
timeFrame: A single point in time (pre-procedural time)
measure: Change in pain severity score
timeFrame: A single point in time (post-procedural 1.month)
measure: Change in pain severity score
timeFrame: A single point in time (post-procedural 3.month)
measure: Change in pain severity score
timeFrame: A single point in time (post-procedural 6.month)
measure: Change in pain severity score
timeFrame: A single point in time (post-procedural 12.month)
measure: Change in the number of patients with neuropathic pain
timeFrame: A single point in time (pre-procedural time)
measure: Change in the number of patients with neuropathic pain
timeFrame: A single point in time (post-procedural 1.month)
measure: Change in the number of patients with neuropathic pain
timeFrame: A single point in time (post-procedural 3.month)
measure: Change in the number of patients with neuropathic pain
timeFrame: A single point in time (post-procedural 6.month)
measure: Change in the number of patients with neuropathic pain
timeFrame: A single point in time (post-procedural 12.month)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Başakşehir Çam & Sakura City Hospital
name: Günay Yolcu, MD
role: PRINCIPAL_INVESTIGATOR
References: