Evaluation of the Effect of Caudal Epidural Pulsed Radiofrequency Stimulation on Chronic Pain

Evaluation of the Effect of Ultrasound Guided Caudal Epidural Pulsed Radiofrequency Stimulation on Chronic Pain in Patients With Failed Back Surgery Syndrome

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05062993

Enrollment

Registered

2021-09-30

Start date

2021-02-22

Completion date

2021-07-01

Last updated

2022-02-07

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

Conditions

Pain, Chronic

Keywords

caudal epidural stimulation, chronic pain, lumbosacral radiculopathy, postlumbar surgery syndrome

Brief summary

Postlumbar surgery syndrome (PLSS; failed back syndrome) is characterized by persistent pain in the lower back or lower extremities after spinal surgery. It occurs in 10-40% of patients who undergo a back surgery. The recently introduced pulsed radiofrequency (PRF) technique is widely used to provide relief from chronic pain and studies have shown that PRF stimulation can be used to control neuropathic pain by placing the needle electrodes into the caudal epidural space The aim of this study is evaluation of the effect of ultrasound guided caudal epidural pulsed radiofrequency stimulation in patients with chronic lumbosacral radicular pain due to postlumbar surgery syndrome.

Interventions

PROCEDUREcaudal epidural pulse radio frequency

A needle is inserted into the caudal epidural space under ultrasound guidance and pulse radiofrequency is administered at 5 Hz using a 5. ms pulse width for 600 seconds at 55 V.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* chronic pain in legs or back pain * unsatisfactory response to at least one transforaminal, lumbar or caudal steroid injections

Exclusion criteria

* coagulation disorders * psychiatric disorders * rheumatoid disorders * infections

Design outcomes

Primary

Measure	Time frame	Description
Numeric Rating Scale(NRS) (0-10)	before procedure	The 11-point NRS consists of numbers between 0 and 10 where 0 indicates no pain and 10 indicates maximum pain. The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
Numeric Rating Scale	2 weeks after procedure	The 11-point NRS consists of numbers between 0 and 10 where 0 indicates no pain and 10 indicates maximum pain. The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.

Countries

Turkey (Türkiye)

Outcome results

None listed

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