Radiocontrast Media in the Pulsed Radiofrequency Treatment

NCT ID: NCT04876469

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-07-01

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.

Conditions

Lumbar Radiculopathy; Pain, Intractable

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiocontrast media group

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.

Group Type: ACTIVE_COMPARATOR

Pulsed Radiofrequency treatment of the lumbar dorsal root ganglion

Intervention Type: PROCEDURE

Using radiocontrast media or not for the pulsed radiofrequency treatment of the lumbar dorsal root ganglion

Non-radiocontrast media group

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.

Group Type: ACTIVE_COMPARATOR

Pulsed Radiofrequency treatment of the lumbar dorsal root ganglion

Intervention Type: PROCEDURE

Using radiocontrast media or not for the pulsed radiofrequency treatment of the lumbar dorsal root ganglion

Interventions

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanliurfa Education and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Serdar Kokar

Pain Management Physician, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sanliurfa Education and Research Hospital

Sanliurfa, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

Serdar Kokar

Role: primary

srdrkkr@hotmail.com

+905416415143

References

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.

Reference Type: BACKGROUND

PMID: 21253377 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27224659 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28700369 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18719452 (View on PubMed)

Other Identifiers

01.02.2021-E.7779

Identifier Type: -

Identifier Source: org_study_id