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Radiocontrast Media in the Pulsed Radiofrequency Treatment

Primary Purpose

Lumbar Radiculopathy, Pain, Intractable

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pulsed Radiofrequency treatment of the lumbar dorsal root ganglion
Sponsored by
Sanliurfa Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Radiculopathy focused on measuring pulsed radiofrequency treatment, lumbar radicular pain, fluoroscopy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-65 years of age.
  • Lumbar radicular pain
  • Lack of response to conservative methods
  • L5 nerve root compression due to disc herniation

Exclusion Criteria:

  • Patients younger than 18 and older than 65
  • Non-radicular low back pain
  • L5 nerve root compression due to reasons other than disc herniation
  • Those having spondylolisthesis, or transitional vertebra
  • Having an active infection
  • Pregnancy
  • Bleeding diathesis
  • Renal Insufficiency

Sites / Locations

  • Sanliurfa Education and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Radiocontrast media group

Non-radiocontrast media group

Arm Description

Pulsed radiofrequency (PRF) treatment will be applied to the dorsal root ganglion (DRG) by fluoroscopy-guidance at the level of nerve root compression due to disc herniation (L5 level) in both groups. In patients in the Radiocontrast media group, contrast material will be given before the application, and primarily the localization of the DRG will be determined. After this stage, the needle will be directed towards the detected localization. Finally, the localization of the dorsal root ganglion will be confirmed by sensory and motor stimuli.

Pulsed radiofrequency (PRF) treatment will be applied to the dorsal root ganglion (DRG) by fluoroscopy-guidance at the level of nerve root compression due to disc herniation (L5 level). In patients in the Non-radiocontrast media group, the localization of the dorsal root ganglion will be determined just by sensory and motor stimuli.

Outcomes

Primary Outcome Measures

Procedure time
The time from cutaneous anesthesia to confirmation of the dorsal root ganglion position by motor and sensory stimulation.

Secondary Outcome Measures

Full Information

First Posted
May 3, 2021
Last Updated
May 3, 2021
Sponsor
Sanliurfa Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04876469
Brief Title
Radiocontrast Media in the Pulsed Radiofrequency Treatment
Official Title
The Role of Radiocontrast Media in Pulsed Radiofrequency Treatment of Lumbar Dorsal Root Ganglion
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sanliurfa Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pulsed radiofrequency applied to the dorsal root ganglion (DRG) is an interventional treatment alternative in the treatment of lumbar radicular pain that does not respond to conservative methods. Under intermittent fluoroscopic imaging, the location of the ganglion can be determined by administering contrast media. We consider that determining the localization of the ganglion with this method during pulse radiofrequency application can shorten the procedure time. In this way, we believe that it would help the correct application of the procedure.
Detailed Description
Although there are many reasons that can lead to low back pain, radicular pain, which is mostly secondary to lumbar disc hernia, is one of the most common pathologies. Pulsed radiofrequency applied to the dorsal root ganglion (DRG) is an interventional treatment alternative in the treatment of lumbar radicular pain that does not respond to conservative methods and epidural injection treatments. The electrical field created by the application of pulsed radiofrequency (PRF) changes the cellular activity in DRG neurons. By polarizing cell membranes, reduces nociceptive transmission and contributes to analgesia. In lumbar dorsal root ganglion PRF applications, when the targeted point is reached, the position is confirmed by giving motor and sensory stimuli, and the PRF application is initiated in the follow-up. However, it is a problem that the DRG is not always in the same location, and therefore, time is often lost or even not found while searching with stimulation. Under intermittent fluoroscopic imaging, the location of the ganglion can be determined by administering contrast material. We consider that determining the localization of the ganglion with this method during pulse radiofrequency application can shorten the procedure time. In this way, we believe that it would help the correct application of the procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy, Pain, Intractable
Keywords
pulsed radiofrequency treatment, lumbar radicular pain, fluoroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiocontrast media group
Arm Type
Active Comparator
Arm Description
Pulsed radiofrequency (PRF) treatment will be applied to the dorsal root ganglion (DRG) by fluoroscopy-guidance at the level of nerve root compression due to disc herniation (L5 level) in both groups. In patients in the Radiocontrast media group, contrast material will be given before the application, and primarily the localization of the DRG will be determined. After this stage, the needle will be directed towards the detected localization. Finally, the localization of the dorsal root ganglion will be confirmed by sensory and motor stimuli.
Arm Title
Non-radiocontrast media group
Arm Type
Active Comparator
Arm Description
Pulsed radiofrequency (PRF) treatment will be applied to the dorsal root ganglion (DRG) by fluoroscopy-guidance at the level of nerve root compression due to disc herniation (L5 level). In patients in the Non-radiocontrast media group, the localization of the dorsal root ganglion will be determined just by sensory and motor stimuli.
Intervention Type
Procedure
Intervention Name(s)
Pulsed Radiofrequency treatment of the lumbar dorsal root ganglion
Intervention Description
Using radiocontrast media or not for the pulsed radiofrequency treatment of the lumbar dorsal root ganglion
Primary Outcome Measure Information:
Title
Procedure time
Description
The time from cutaneous anesthesia to confirmation of the dorsal root ganglion position by motor and sensory stimulation.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-65 years of age. Lumbar radicular pain Lack of response to conservative methods L5 nerve root compression due to disc herniation Exclusion Criteria: Patients younger than 18 and older than 65 Non-radicular low back pain L5 nerve root compression due to reasons other than disc herniation Those having spondylolisthesis, or transitional vertebra Having an active infection Pregnancy Bleeding diathesis Renal Insufficiency
Facility Information:
Facility Name
Sanliurfa Education and Research Hospital
City
Sanliurfa
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serdar Kokar
Phone
+905416415143
Email
srdrkkr@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21253377
Citation
Moon HS, Kim YD, Song BH, Cha YD, Song JH, Lee MH. Position of dorsal root ganglia in the lumbosacral region in patients with radiculopathy. Korean J Anesthesiol. 2010 Dec;59(6):398-402. doi: 10.4097/kjae.2010.59.6.398. Epub 2010 Dec 31.
Results Reference
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PubMed Identifier
27224659
Citation
Liem L, van Dongen E, Huygen FJ, Staats P, Kramer J. The Dorsal Root Ganglion as a Therapeutic Target for Chronic Pain. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):511-9. doi: 10.1097/AAP.0000000000000408.
Results Reference
background
PubMed Identifier
28700369
Citation
Vanneste T, Van Lantschoot A, Van Boxem K, Van Zundert J. Pulsed radiofrequency in chronic pain. Curr Opin Anaesthesiol. 2017 Oct;30(5):577-582. doi: 10.1097/ACO.0000000000000502.
Results Reference
background
PubMed Identifier
18719452
Citation
Malik K, Benzon HT. Radiofrequency applications to dorsal root ganglia: a literature review. Anesthesiology. 2008 Sep;109(3):527-42. doi: 10.1097/ALN.0b013e318182c86e.
Results Reference
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Radiocontrast Media in the Pulsed Radiofrequency Treatment

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