Completed

NCT Number: NCT05749185

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

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.

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Key information

Conditions

Chronic Cervical Radiculopathy

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mina Raouf

Al Fayyum, 61511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

radiofrequency high voltage

Device

nvolved a high voltage PRF technique, where the voltage started at 65 V and could be adjusted up to 80 V based on patient tolerance. Both protocols involved two cycles of PRF application, with each cycle lasting 240 seconds and comprising alternating periods of current application and deactivation. The pulse rate frequency was set at 2 Hertz (Hz), resulting in two active phases/second (20 milliseconds (ms) of current application followed by 480 ms without stimulation)

standard RF

Procedure

A standard voltage PRF technique, administering PRF at a fixed voltage of 45 volts (V)

Primary outcomes

visual analogue score

Time frame: 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 outcomes

Neck disability index

Time frame: 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
Incidence of procedure related adverse events

Time frame: 6 hours after the procedure

cervical epidural hematoma, nerve injury

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Comparison Between the Effectiveness of Ultrasound-Guided High Voltage Pulsed Radiofrequency Versus Standard Voltage Pulsed Radiofrequency for Cervical Nerve Roots in Patients With Refractory Chronic Unilateral Cervical Radicular Pain

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Mar 1, 2023
Registry last updated: Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.