NCT06756893

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Ankara University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Lumbar radicular pain is characterized by sharp, stabbing, or throbbing pain radiating to one or more dermatomes. It is a common and challenging condition for clinicians to manage in pain practice. Conservative treatments such as physical therapy, non-steroidal anti-inflammatory drugs, rest, and exercise may fail, leading to chronic pain. In such cases, minimally invasive methods such as epidural steroid injection (ESI) or pulsed radiofrequency (pRF) of the dorsal root ganglion (DRG) may be preferred. Unlike conventional radiofrequency, pRF does not cause ablation. Due to the intermittent delivery of energy generated by the electric current, the target tissue temperature does not exceed 42°C. This creates a magnetic field that modulates pain without causing neuronal damage. The DRG, highly sensitive to mechanical compression, is a critical target in radicular pain. There is evidence supporting the efficacy of DRG pRF in chronic lumbar radicular pain. Studies comparing pRF alone or in combination with ESI versus ESI alone have found it effective in providing long-term pain relief. However, despite the increasing body of evidence, studies are lacking on the impact of the proximity of pRF to the target neuronal tissue on clinical outcomes. The primary aim of this study is to investigate the relationship between the sensory stimulation threshold, indicating the proximity to the target tissue during DRG pRF, and the reduction in Numeric Rating Scale (NRS) scores at the 3-month follow-up. Secondary objectives include examining the relationship between Oswestry Disability Index (ODI) and NRS scores at various assessment time points. The DRG, highly sensitive to mechanical compression, is a critical target in radicular pain (5,6). There is evidence supporting the efficacy of DRG pRF in chronic lumbar radicular pain. Studies comparing pRF alone or in combination with ESI versus ESI alone have found it effective in providing long-term pain relief (7). However, despite the increasing body of evidence, studies are lacking on the impact of the proximity of pRF to the target neuronal tissue on clinical outcomes. The primary aim of this study is to investigate the relationship between the sensory stimulation threshold, indicating the proximity to the target tissue during DRG pRF, and the reduction in Numeric Rating Scale (NRS) scores at the 3-month follow-up. Secondary objectives include examining the relationship between Oswestry Disability Index (ODI) and NRS scores at various assessment time points.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Dorsal Root Ganglion Pulsed Radiofrequency	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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-07-01
• Completion: 2025-10-01
• First posted: 2025-01-03
• Last updated: 2025-01-03