The Effect of Sensory Stimulation Threshold on the Efficacy of Pulsed Radiofrequency Applied to the Dorsal Root Ganglion in Patients with Chronic Lumbar Radicular Pain

NCT06756893 | Not Yet Recruiting

• 1 other identifier: 2024/766
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Lomber dorsal root ganglion pRF is an interventional treatment options in the treatment of lumbar radicular pain. The goal of this study is to investigate the effect of sensory threshold outcomes on pain severity during dorsal root ganglion pulsed radiofrequency (DRG-pRF). It will also learn effects about disability due to chronic LRP. The main questions it aims to answer are: Does lower sensory threshold result in lower pain scores and chronic LRP related disability? Participants will: Take DRG-pRF procedure for 4 minutes. Visit the clinic at 1. and 3. month for questionnaries.

Conditions

Dorsal Root Ganglion; Pulsed Radiofrequency; Chronic Pain; Lumbar Radiculopathy; Lumbar Spinal Stenosis

Keywords

dorsal root ganglion; pulsed radiofrequency; lumbar radiculopathy; pain related disability

Outcome Measures

Primary Outcomes (1)

• Postprocedure pain severity at 3th month

  Severity of pain will be assessed with Numeric Rating Scale (NRS-11) at 3 months after interventions. NRS-11 is a 11 point likert type scale. Higher scores represent more severe pain.

  From procedure to 3 months after prodecure

Secondary Outcomes (4)

• Postprocedure pain severity at 30. min

  From procedure to 30 minustes after procedure

• Postprocedure first month pain severity

  From procedure to 1 month after procedure

• Postprocedure first month OSWESTRY scores

  From procedure to 1 month after procedure

• Postprocedure 3th month OSWESTRY scores

  From procedure to 3 month after procedure

Study Arms (1)

Dorsal Root Ganglion Pulsed Radiofrequency

Procedure: Dorsal Root Ganglion Pulsed Radiofrequency

Interventions

Dorsal Root Ganglion Pulsed Radiofrequency PROCEDURE

Using C-arm fluoroscopy, a 22G, 10 cm RF needle with a 5 mm active tip will be directed from lateral to medial towards the vertebral foramen. Once the needle reaches the lateral edge of the pedicle shadow, the C-arm will be adjusted to a lateral view to confirm that the needle is located at the craniodorsal portion of the intervertebral foramen. Sensory stimulation will be delivered through the RF generator at 50 Hz, and paresthesia will be sought in the corresponding dermatome at values between 0.4-0.8 mA. After achieving paresthesia, motor stimulation at 2 Hz will be applied, and the location near the DRG will be confirmed if motor stimulation is not elicited at values less than 1.5 times the sensory threshold. Pulsed RF will then be applied for 4 minutes at a setting of 45 V, 20 ms pulse width, and 2 Hz frequency. Following the application, needle will be directed slightly anterior and after appropriate contrast flow, dexamethasone will be injected.

Dorsal Root Ganglion Pulsed Radiofrequency

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Candidates who visited algology clinic of Ankara University Medicine Faculty Hospitals to DRG-pRF prodecure for chronic LRP.

You may qualify if:

• Pain lasting ≥3 months NRS score ≥4 Unilateral pain Diagnosis of spinal stenosis or lumbar disc herniation causing root compression, confirmed by magnetic resonance imaging (MRI) according to appropriate diagnostic criteria and classification Failure of conservative treatment

You may not qualify if:

• Unwillingness to participate in the study Epidural steroid injection within the past month Uncontrolled psychiatric disorders despite medical treatment Systemic or localized infection signs at the procedure site Severe spinal stenosis Allergy to steroids or contrast agents History of cancer Coagulopathy

Sponsors & Collaborators

• Ankara University: lead

Related Publications (2)

• Cohen SP, Strassels SA, Kurihara C, Lesnick IK, Hanling SR, Griffith SR, Buckenmaier CC 3rd, Nguyen C. Does sensory stimulation threshold affect lumbar facet radiofrequency denervation outcomes? A prospective clinical correlational study. Anesth Analg. 2011 Nov;113(5):1233-41. doi: 10.1213/ANE.0b013e31822dd379. Epub 2011 Sep 14.

  PMID: 21918166 BACKGROUND

• Park S, Park JH, Jang JN, Choi SI, Song Y, Kim YU, Park S. Pulsed radiofrequency of lumbar dorsal root ganglion for lumbar radicular pain: A systematic review and meta-analysis. Pain Pract. 2024 Jun;24(5):772-785. doi: 10.1111/papr.13351. Epub 2024 Jan 31.

  PMID: 38294072 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Radiculopathy; Spinal Stenosis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Güngör Enver Özgencil, MD

  Ankara University Medicine Faculty Anesthesiology and Reanimation Department

  STUDY DIRECTOR

Central Study Contacts

Hanzade Aybuke Unal, MD

CONTACT

+905057179039; hanzadeunal@windowslive.com

Ersin Sönmez, MD

CONTACT

+905370257858; ersins@outlook.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 3, 2025
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 5 years after January 2026
• Access Criteria: Upon reasonable request