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

NCT ID: NCT05950321

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-08-20

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.

Conditions

Neck Pain; Cervical Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cervical epidural group

Paramedian cervical epidural injection for cervical radiculopathy

Group Type: ACTIVE_COMPARATOR

Paramedian cervical epidural steroid injection

Intervention Type: 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.

Radiofrequency group

Pulsed radiofrequency applied to nerve roots for cervical radiculopathy

Group Type: ACTIVE_COMPARATOR

Selective nerve root pulsed radiofrequency

Intervention Type: 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.

Interventions

Paramedian cervical epidural steroid injection

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

Selective nerve root pulsed radiofrequency

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diskapi Teaching and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Damla Yürük

Supervisor Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gevher Rabia Genc Perdecioğlu

Role: STUDY_CHAIR

Diskapi TRH

Locations

Diskapi Training and Research Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Paramedian cesi vs root prf

Identifier Type: -

Identifier Source: org_study_id