Chronic Cervical RadiculopathyNCT05749185
High Versus Standard Voltage Pulsed Radiofrequency for Cervical Nerve Roots Injection in Refractory Chronic Unilateral Cervical Radicular Pain
A study testing radiofrequency high voltage and standard RF in people with Chronic Cervical Radiculopathy, run by Minia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Chronic Cervical Radiculopathy
- What is being tested?
- radiofrequency high voltage and standard RF
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Feb 2023to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Chronic Cervical Radiculopathy
- Being tested
- radiofrequency high voltage, standard RF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency high voltageDevice
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 RFProcedure or surgery
A standard voltage PRF technique, administering PRF at a fixed voltage of 45 volts (V)
| Study group | Role | What they receive |
|---|---|---|
| Group H ( high voltage) radiofrequency | Active comparator | 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). Receives: Device: radiofrequency high voltage |
| Group S ( standard) radiofrequency | Active comparator | utilized a standard voltage PRF technique, administering PRF at a fixed voltage of 45 volts (V). Receives: Procedure: standard RF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: pre-treatment, 1,3, and 6 month after intervention
Secondary outcomes (2)
Neck disability index
1- the impact of treatment on the Neck Disability Index which was evaluated before treatment and at 6 months following treatment
Measured: pre-treatment, 1,3 and 6 months after intervention
Incidence of procedure related adverse events
cervical epidural hematoma, nerve injury
Measured: 6 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start22 Feb 2023
- Primary completion12 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Maher, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749185
- Sponsor's protocol ID
- R-247
- Status last verified
- Jun 2024
- First submitted
- 9 Feb 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05749185
- Acronym / sponsor ID
- R-247
- Conditions
- Chronic Cervical Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group H ( high voltage) radiofrequency | Active comparator | Device: radiofrequency high voltageGroup 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 S ( standard) radiofrequency | Active comparator | Procedure: standard RFutilized a standard voltage PRF technique, administering PRF at a fixed voltage of 45 volts (V). |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiofrequency high voltagenvolved 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 | Group H ( high voltage) radiofrequency |
| standard RFA standard voltage PRF technique, administering PRF at a fixed voltage of 45 volts (V) | Procedure or surgery | Group S ( standard) radiofrequency |
Primary outcome
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
2 secondary outcomes
Neck disability index
Time frame: pre-treatment, 1,3 and 6 months after intervention
Incidence of procedure related adverse events
Time frame: 6 hours after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 40617971Alsaeid 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequency high voltage and standard RF in people with Chronic Cervical Radiculopathy, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue score (time frame: pre-treatment, 1,3, and 6 month after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05749185, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.