High Versus Standard Voltage Pulsed Radiofrequency for Cervical Nerve Roots Injection in Refractory Chronic Unilateral Cervical Radicular Pain

Not Applicable

Completed

• Conditions: Chronic Cervical Radiculopathy

• Registration Number: NCT05749185
• Lead Sponsor: Minia University

Brief Summary

The goal of this interventional study is to compare efficacy of either standard versus supra-voltage radiofrequency cervical epidural injection in pain alleviation in population with chronic cervical radiculopathy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-18
• Study Start: 2023-02-22
• Study First Posted: 2023-03-01
• Primary Completion: 2024-03-12
• Study Completion: 2024-04-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-30
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age between 20 and 70 years, both genders.
• American Society of Anesthesiologists (ASA) physical status grades I or II.
• Unilateral cervical radicular pain secondary to cervical disc prolapse affecting single nerve root which was refractory to conventional conservative and physiotherapy measures for 12 weeks or more.
• All candidates received 1 millilitre of 2% lidocaine via an ultrasound-guided diagnostic nerve block and informed at least 50% momentary reduction of their pain.
• Diagnosis was confirmed by cervical MRI and nerve conduction tests.

Exclusion Criteria

• Refusal to participate.
• Cervical radiculopathy pain recurrence after surgery.
• Previous attempt of radiofrequency ablation.
• Concomitant coagulopathic state ( decompensated liver disease, clopidogrel use) .
• Metastatic lesion in the cervical vertebral column.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
visual analogue score	pre-treatment, 1,3, and 6 month after intervention	Number of patients with successful pain relief at 6 months post-intervention which is defined as more than or equal 50% reduction in VAS from pre-interventional level; Vas score ranges from 0 to ten . 0= NO pain.... 1-3= mild pain .... 4-6 = moderate pain ... 6-10= severe untearable pain

Secondary Outcome Measures

Name	Time	Method
Incidence of procedure related adverse events	6 hours after the procedure	cervical epidural hematoma, nerve injury
Neck disability index	pre-treatment, 1,3 and 6 months after intervention	1- the impact of treatment on the Neck Disability Index which was evaluated before treatment and at 6 months following treatment

Trial Locations

Locations (1)

Mina Raouf; 🇪🇬 Fayoum, Egypt