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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-22

Study Completion Date

2024-04-01

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Cervical Radiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group H ( high voltage) radiofrequency

Group H, involved 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).

Group Type ACTIVE_COMPARATOR

radiofrequency high voltage

Intervention Type 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)

Group S ( standard) radiofrequency

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

Group Type ACTIVE_COMPARATOR

standard RF

Intervention Type PROCEDURE

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

Interventions

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radiofrequency high voltage

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)

Intervention Type DEVICE

standard RF

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No