Clinical trial 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dorsal Root Ganglion
Pulsed Radiofrequency
Chronic Pain
Lumbar Radiculopathy
Lumbar Spinal Stenosis
Keywords: dorsal root ganglion
pulsed radiofrequency
lumbar radiculopathy
pain related disability
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Candidates who visited algology clinic of Ankara University Medicine Faculty Hospitals to DRG-pRF prodecure for chronic LRP.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Postprocedure pain severity at 3th month
timeFrame: From procedure to 3 months after prodecure
Secondary outcomes:
measure: Postprocedure pain severity at 30. min
timeFrame: From procedure to 30 minustes after procedure
measure: Postprocedure first month pain severity
timeFrame: From procedure to 1 month after procedure
measure: Postprocedure first month OSWESTRY scores
timeFrame: From procedure to 1 month after procedure
measure: Postprocedure 3th month OSWESTRY scores
timeFrame: From procedure to 3 month after procedure
Other outcomes:
Locations:
Study officials:
affiliation: Ankara University Medicine Faculty Anesthesiology and Reanimation Department
name: Güngör Enver Özgencil, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.