- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05062993
Evaluation of the Effect of Caudal Epidural Pulsed Radiofrequency Stimulation on Chronic Pain
January 24, 2022 updated by: Selin Guven Kose, Diskapi Teaching and Research Hospital
Evaluation of the Effect of Ultrasound Guided Caudal Epidural Pulsed Radiofrequency Stimulation on Chronic Pain in Patients With Failed Back Surgery Syndrome
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey, 06110
- Diskapi Yildirim Beyazit Training and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: study group
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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before procedure
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Numeric Rating Scale
Time Frame: 2 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.
|
2 weeks after procedure
|
Numeric Rating Scale
Time Frame: 4 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.
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4 weeks after procedure
|
Numeric Rating Scale
Time Frame: 8 weeks after procedure
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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.
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8 weeks after procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 22, 2021
Primary Completion (Actual)
May 1, 2021
Study Completion (Actual)
July 1, 2021
Study Registration Dates
First Submitted
July 7, 2021
First Submitted That Met QC Criteria
September 29, 2021
First Posted (Actual)
September 30, 2021
Study Record Updates
Last Update Posted (Actual)
February 7, 2022
Last Update Submitted That Met QC Criteria
January 24, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 98/08
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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