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

NCT05062993 | Completed

• 1 other identifier: 98/08
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

study group

EXPERIMENTAL

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.

Procedure: caudal epidural pulse radio frequency

Interventions

caudal epidural pulse radio frequency PROCEDURE

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 group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• coagulation disorders
• psychiatric disorders
• rheumatoid disorders
• infections

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Diskapi Yildirim Beyazit Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Selin Guven Kose

  Diskapi Yildirim Beyazit Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: September 30, 2021
• Study Start: February 22, 2021
• Primary Completion: May 1, 2021
• Study Completion: July 1, 2021
• Last Updated: February 7, 2022

Record last verified: 2022-01

Locations

TU (1)