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

Pain, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05062993
• Other study ID #: 98/08
• Status: Completed
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: January 2022
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

Procedure:
• caudal 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.

Locations

Country	Name	City	State
Turkey	Diskapi Yildirim Beyazit Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scale(NRS) (0-10)	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.	before procedure
Primary	Numeric Rating Scale	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.	2 weeks after procedure
Primary	Numeric Rating Scale	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.	4 weeks after procedure
Primary	Numeric Rating Scale	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.	8 weeks after procedure