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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Chronic

Intervention / Treatment
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* Procedure: caudal epidural pulse radio frequency


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caudal epidural stimulation, chronic pain, lumbosacral radiculopathy, postlumbar surgery syndrome