Clinical trial NCT05950321: Paramedian CESI vs Selective Nerve Root PRF for Lower Cervical Radicular Pain
Official title: Comparison of Fluoroscopy-guided Cervical Paramedian Interlaminar Epidural Block Versus Ultrasound-guided Selective Nerve Root Pulsed Radiofrequency for the Management of Chronic Lower Cervical Radicular Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Cervical Radiculopathy
Keywords: Pulsed Radiofrequency Treatment
Fluoroscopy
Steroids
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the efficacy of ultrasound-guided selective cervical nerve root pulsed radiofrequency (PRF) versus fluoroscopy-guided paramedian cervical epidural steroid administration (CESI) for the treatment of lower cervical radicular pain refractory to conservative treatments. For this evaluation, a numerical rating (NRS), neck disability index (NDI), and Leeds Assessment Of Neuropathic Symptoms And Signs (LANSS) scale will be used before and after both interventions.

Detailed description: Chronic cervical radicular pain is a common condition that affects the quality of life of many patients and is caused by compression or irritation of the cervical nerve roots. Treatment options for this condition include conservative methods such as medications and physical therapy, as well as interventions such as surgery or injections.

Two commonly used injections for chronic cervical radicular pain are ultrasound-guided selective nerve root PRF and fluoroscopy-guided paramedian CESI. PRF involves the application of pulsed radiofrequency energy (intermittent current, tissue temperature not exceeding 42 °C) to the cervical nerve root under ultrasound guidance. PRF is a non-destructive technique that modulates the activity of nerve fibers without causing thermal damage. CESI involves injecting local anesthetic and steroids into the epidural space between the laminae of the vertebrae under fluoroscopic guidance. The aim of both techniques is to reduce inflammation and pain transmission from the affected nerve root. The efficacy of both CESI and selective nerve root PRF has been demonstrated in clinical trials.

The primary aim of the investigators in this study is to compare the efficacy of these two treatments. A total of at least 60 patients, 30 patients in each group, will be enrolled for comparison. NRS, NDI, and LANSS scores before, 3 months, and 6 months after treatment will be compared both within and between groups. The secondary aim is to reveal the side effects and adverse events in these two treatment modalities.

Eligibility criteria: Inclusion Criteria:

* Severe unilateral radicular pain due to cervical disc herniation (pain with a severity of 6 or more on a numeric rating scale of 0-10)
* Continued pain for more than 3 months
* Demonstration of herniated disc compression of the lower cervical spinal nerve roots on magnetic resonance imaging
* Failure in pain management with conservative methods such as analgesics and physical therapy

Exclusion Criteria:

* Pain radiating to both arms, hands or neck pain in the foreground
* Spinal stenosis or spondylolisthesis (only those with radicular pain due to disc herniation will be included)
* Cognitive impairment
* Hepatic or renal insufficiency
* Severe psychiatric illness
* Local or systemic infection
* Coagulopathy

Primary outcomes:
measure: Numerical rating scale (NRS)
timeFrame: Change from baseline to 3rd and 6th month after treatment
Secondary outcomes:
measure: The Neck Disability Index (NDI)
timeFrame: Change from baseline to 3rd and 6th month after treatment
measure: Leeds Assessment Of Neuropathic Symptoms And Signs (LANSS)
timeFrame: Change from baseline to 3rd and 6th month after treatment
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Training and Research Hospital
Study officials:
affiliation: Diskapi TRH
name: Gevher Rabia Genc Perdecioğlu
role: STUDY_CHAIR
References: