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

Not Applicable

Completed

• Conditions: Pain, Chronic
• Interventions: Procedure: caudal epidural pulse radio frequency

• Registration Number: NCT05062993
• Lead Sponsor: Diskapi Teaching and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-22
• Primary Completion: 2021-05-01
• Study Completion: 2021-07-01
• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-09-29
• Study First Posted: 2021-09-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-24
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study group	caudal epidural pulse radio frequency	Patients with chronic radicular pain will be included in this study. Ultrasound guided caudal epidural pulse radiofrequency technique will be applied to the study group.

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale	8 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.
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.

Trial Locations

Locations (1)

Diskapi Yildirim Beyazit Training and Research Hospital; 🇹🇷 Ankara, Turkey