Evaluation of the Effect of Caudal Epidural Pulsed Radiofrequency Stimulation on Chronic Pain
Primary Purpose
Pain, Chronic
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
caudal epidural pulse radio frequency
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Chronic focused on measuring caudal epidural stimulation, chronic pain, lumbosacral radiculopathy, postlumbar surgery syndrome
Eligibility Criteria
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
Sites / Locations
- Diskapi Yildirim Beyazit Training and Research Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
study group
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05062993
First Posted
July 7, 2021
Last Updated
January 24, 2022
Sponsor
Diskapi Teaching and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05062993
Brief Title
Evaluation of the Effect of Caudal Epidural Pulsed Radiofrequency Stimulation on Chronic Pain
Official Title
Evaluation of the Effect of Ultrasound Guided Caudal Epidural Pulsed Radiofrequency Stimulation on Chronic Pain in Patients With Failed Back Surgery Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
Keywords
caudal epidural stimulation, chronic pain, lumbosacral radiculopathy, postlumbar surgery syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
caudal epidural pulse radio frequency
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Rating Scale(NRS) (0-10)
Description
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.
Time Frame
before procedure
Title
Numeric Rating Scale
Description
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.
Time Frame
2 weeks after procedure
Title
Numeric Rating Scale
Description
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.
Time Frame
4 weeks after procedure
Title
Numeric Rating Scale
Description
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.
Time Frame
8 weeks after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selin Guven Kose
Organizational Affiliation
Diskapi Yildirim Beyazit Education and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diskapi Yildirim Beyazit Training and Research Hospital
City
Ankara
ZIP/Postal Code
06110
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Effect of Caudal Epidural Pulsed Radiofrequency Stimulation on Chronic Pain
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