Paramedian CESI vs Selective Nerve Root PRF for Lower Cervical Radicular Pain

Not Applicable

Completed

• Conditions: Neck Pain; Cervical Radiculopathy
• Interventions: Procedure: Selective nerve root pulsed radiofrequency; Procedure: Paramedian cervical epidural steroid injection

• Registration Number: NCT05950321
• Lead Sponsor: Diskapi Teaching and Research Hospital

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.

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2023-07-10
• Study First Submitted QC: 2023-07-10
• Study First Posted: 2023-07-18
• Primary Completion: 2023-08-05
• Study Completion: 2023-08-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiofrequency group	Selective nerve root pulsed radiofrequency	Pulsed radiofrequency applied to nerve roots for cervical radiculopathy
Cervical epidural group	Paramedian cervical epidural steroid injection	Paramedian cervical epidural injection for cervical radiculopathy

Primary Outcome Measures

Name	Time	Method
Numerical rating scale (NRS)	Change from baseline to 3rd and 6th month after treatment	NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)

Secondary Outcome Measures

Name	Time	Method
The Neck Disability Index (NDI)	Change from baseline to 3rd and 6th month after treatment	The Neck Disability Index (NDI) is a widely used questionnaire designed to assess the impact of neck pain on a person's daily functioning and quality of life. It consists of ten questions covering topics such as pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each question has six possible responses, which are assigned a numerical value. By summing up the scores, the NDI provides a measure of the patient's neck disability ranging from 0% (no disability) to 100% (maximum disability).
Leeds Assessment Of Neuropathic Symptoms And Signs (LANSS)	Change from baseline to 3rd and 6th month after treatment	The Leeds assessment of neuropathic symptoms and signs (LANSS) Pain Scale is based on analysis of sensory description and bedside examination of sensory dysfunction, and provides immediate information in clinical settings. It was developed in two populations of chronic pain patients.

Trial Locations

Locations (1)

Diskapi Training and Research Hospital; 🇹🇷 Ankara, Turkey