NCT04876469

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

May 3, 2021

Last Update Submit

May 3, 2021

Conditions

Lumbar RadiculopathyPain, Intractable

Keywords

pulsed radiofrequency treatmentlumbar radicular painfluoroscopy

Outcome Measures

Primary Outcomes (1)

  • Procedure time

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

    3 months

Study Arms (2)

Radiocontrast media group

ACTIVE COMPARATOR

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.

Procedure: Pulsed Radiofrequency treatment of the lumbar dorsal root ganglion

Non-radiocontrast media group

ACTIVE COMPARATOR

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.

Procedure: Pulsed Radiofrequency treatment of the lumbar dorsal root ganglion

Interventions

Pulsed Radiofrequency treatment of the lumbar dorsal root ganglionPROCEDURE

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

Non-radiocontrast media groupRadiocontrast media group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanliurfa Education and Research Hospital

Sanliurfa, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • 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.

    PMID: 21253377BACKGROUND

  • 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.

    PMID: 27224659BACKGROUND

  • 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.

    PMID: 28700369BACKGROUND

  • 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.

    PMID: 18719452BACKGROUND

MeSH Terms

Conditions

RadiculopathyPain, Intractable

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pain Management Physician, M.D.

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 6, 2021

Study Start

March 1, 2021

Primary Completion

June 1, 2021

Study Completion

July 1, 2021

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)