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Clinical Trials/NCT05062993
NCT05062993CompletedNot Applicable

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

Diskapi Teaching and Research Hospital2 sites in 1 country30 target enrollmentStarted: February 22, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Numeric Rating Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Numeric Rating Scale

Time Frame: 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)

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Selin Guven Kose

Principal Investigator

Diskapi Teaching and Research Hospital

Study Sites (2)

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