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

NCT05950321 | Completed

• 1 other identifier: Paramedian cesi vs root prf
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain; Cervical Radiculopathy

Keywords

Pulsed Radiofrequency Treatment; Fluoroscopy; Steroids

Outcome Measures

Primary Outcomes (1)

• 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)

  Change from baseline to 3rd and 6th month after treatment

Secondary Outcomes (2)

• The Neck Disability Index (NDI)

  Change from baseline to 3rd and 6th month after treatment

• Leeds Assessment Of Neuropathic Symptoms And Signs (LANSS)

  Change from baseline to 3rd and 6th month after treatment

Study Arms (2)

Cervical epidural group

ACTIVE COMPARATOR

Paramedian cervical epidural injection for cervical radiculopathy

Procedure: Paramedian cervical epidural steroid injection

Radiofrequency group

ACTIVE COMPARATOR

Pulsed radiofrequency applied to nerve roots for cervical radiculopathy

Procedure: Selective nerve root pulsed radiofrequency

Interventions

Paramedian cervical epidural steroid injection PROCEDURE

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.

Cervical epidural group

Selective nerve root pulsed radiofrequency PROCEDURE

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.

Radiofrequency group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Diskapi Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain; Radiculopathy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Gevher Rabia Genc Perdecioğlu

  Diskapi TRH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor Investigator

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: August 1, 2022
• Primary Completion: August 5, 2023
• Study Completion: August 20, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

TU (1)