Radiocontrast Media in the Pulsed Radiofrequency Treatment

Not Applicable

• Conditions: Lumbar Radiculopathy; Pain, Intractable
• Interventions: Procedure: Pulsed Radiofrequency treatment of the lumbar dorsal root ganglion

• Registration Number: NCT04876469
• Lead Sponsor: Sanliurfa Education and Research Hospital

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.

Study Timeline

• Study Start: 2021-03-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-03
• Last Update Submitted: 2021-05-03
• Study First Posted: 2021-05-06
• Last Update Posted: 2021-05-06
• Primary Completion: 2021-06-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiocontrast media group	Pulsed Radiofrequency treatment of the lumbar dorsal root ganglion	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.
Non-radiocontrast media group	Pulsed Radiofrequency treatment of the lumbar dorsal root ganglion	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.

Primary Outcome Measures

Name	Time	Method
Procedure time	3 months	The time from cutaneous anesthesia to confirmation of the dorsal root ganglion position by motor and sensory stimulation.

Trial Locations

Locations (1)

Sanliurfa Education and Research Hospital; 🇹🇷 Sanliurfa, Turkey