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

Primary Purpose

Neck Pain, Cervical Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Paramedian cervical epidural steroid injection
Selective nerve root pulsed radiofrequency
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Pulsed Radiofrequency Treatment, Fluoroscopy, Steroids

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Diskapi Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cervical epidural group

Radiofrequency group

Arm Description

Paramedian cervical epidural injection for cervical radiculopathy

Pulsed radiofrequency applied to nerve roots for cervical radiculopathy

Outcomes

Primary Outcome Measures

Numerical rating scale (NRS)
NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)

Secondary Outcome Measures

The Neck Disability Index (NDI)
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)
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.

Full Information

First Posted
July 10, 2023
Last Updated
September 15, 2023
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05950321
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 5, 2023 (Actual)
Study Completion Date
August 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Cervical Radiculopathy
Keywords
Pulsed Radiofrequency Treatment, Fluoroscopy, Steroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cervical epidural group
Arm Type
Active Comparator
Arm Description
Paramedian cervical epidural injection for cervical radiculopathy
Arm Title
Radiofrequency group
Arm Type
Active Comparator
Arm Description
Pulsed radiofrequency applied to nerve roots for cervical radiculopathy
Intervention Type
Procedure
Intervention Name(s)
Paramedian cervical epidural steroid injection
Intervention Description
For paramedian cervical epidural steroid injection, the cervical 7 (C7) - thoracic 1 (T1) interval is determined by taking an appropriate angle with C-arm fluoroscopy to determine the interlaminar space from the posterior cervical region. The epidural space is recognized by the negative pressure reflected on the resistance syringe.
Intervention Type
Procedure
Intervention Name(s)
Selective nerve root pulsed radiofrequency
Intervention Description
For selective nerve root PRF, an 8-12 Hz linear ultrasound probe is first placed posterolateral to the neck. The level of the cervical nerve roots is determined according to the morphology of the anterior and posterior vertebral tubercles. The corresponding nerve root is visualized hypoechoically between the tubercles. The radiofrequency cannula is inserted in the same plane as the ultrasound probe (in plane) and the relevant nerve root is approached. Pulsed radiofrequency current, which has therapeutic properties in chronic pain, is applied to the relevant nerve root for 240 seconds.
Primary Outcome Measure Information:
Title
Numerical rating scale (NRS)
Description
NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
Time Frame
Change from baseline to 3rd and 6th month after treatment
Secondary Outcome Measure Information:
Title
The Neck Disability Index (NDI)
Description
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).
Time Frame
Change from baseline to 3rd and 6th month after treatment
Title
Leeds Assessment Of Neuropathic Symptoms And Signs (LANSS)
Description
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.
Time Frame
Change from baseline to 3rd and 6th month after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gevher Rabia Genc Perdecioğlu
Organizational Affiliation
Diskapi TRH
Official's Role
Study Chair
Facility Information:
Facility Name
Diskapi Training and Research Hospital
City
Ankara
Country
Turkey

12. IPD Sharing Statement

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

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