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Epidural Pulsed Radiofrequency Treatment in Failed Back Surgery Syndrome

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06239857
Enrollment
38
Registered
2024-02-02
Start date
2024-02-15
Completion date
2024-07-30
Last updated
2024-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain, Failed Back Surgery Syndrome, Neuropathic Pain

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.

Interventions

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.

Sponsors

Başakşehir Çam & Sakura City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in pain severity scoreA single point in time (pre-procedural time)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 painA single point in time (pre-procedural time)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.

Contacts

Primary ContactBurak Erken, MD
burak_erken@hotmail.com+902129096000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026