Radiocontrast Media in the Pulsed Radiofrequency Treatment

Lumbar Radiculopathy Clinical Trial

Official title:

The Role of Radiocontrast Media in Pulsed Radiofrequency Treatment of Lumbar Dorsal Root Ganglion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04876469
• Other study ID #: 01.02.2021-E.7779
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: May 2021
• Source: Sanliurfa Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Radiculopathy
• Pain, Intractable
• Radiculopathy

Intervention

Procedure:
• Pulsed Radiofrequency treatment of the lumbar dorsal root ganglion
Using radiocontrast media or not for the pulsed radiofrequency treatment of the lumbar dorsal root ganglion

Locations

Country	Name	City	State
Turkey	Sanliurfa Education and Research Hospital	Sanliurfa

Sponsors (1)

Lead Sponsor	Collaborator
Sanliurfa Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. Review. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure time	The time from cutaneous anesthesia to confirmation of the dorsal root ganglion position by motor and sensory stimulation.	3 months