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CompletedNCT05749185Updated Jul 3, 2024

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

An interventional study of radiofrequency high voltage and standard RF in Chronic Cervical Radiculopathy, sponsored by Minia University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by Minia University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Cervical Radiculopathy
03

In context

Lead sponsor

Minia University is the lead sponsor of 369 studies on the registry; 117 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    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).

    Device: radiofrequency high voltage

  • Active comparator
    Group S ( standard) radiofrequency

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

    Procedure: standard RF

Interventions

  • Deviceradiofrequency 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)

  • Procedurestandard RF

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

06

What researchers measure

Primary outcomes

  1. visual analogue score

    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

    Time frame: pre-treatment, 1,3, and 6 month after intervention

Secondary outcomes

  1. Neck disability index

    1- the impact of treatment on the Neck Disability Index which was evaluated before treatment and at 6 months following treatment

    Time frame: pre-treatment, 1,3 and 6 months after intervention

  2. Incidence of procedure related adverse events

    cervical epidural hematoma, nerve injury

    Time frame: 6 hours after the procedure

07

Study locations

1 site
  • Mina Raouf
    Al Fayyum, 61511, Egypt
08

References and documents

Publications

  • Alsaeid MA, Algyar MF, Mahmoud AM, Farghaly OS, Salah AG, Raouf MM. Ultrasound-guided high-voltage pulsed radiofrequency versus standard-voltage pulsed radiofrequency in refractory chronic cervical radicular pain randomized clinical trial. J Anesth. 2025 Dec;39(6):929-939. doi: 10.1007/s00540-025-03535-5. Epub 2025 Jul 5. PubMed 40617971 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05749185
Lead sponsor
Minia University
Responsible party
Mina Maher (lecturer of anesthesia and pain medicine, Minia University) — Principal investigator
First posted
Mar 1, 2023
Start date
Feb 22, 2023
Primary completion
Mar 12, 2024
Completion
Apr 1, 2024
Last update
Jul 3, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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