Back to resultsHigh Versus Standard Voltage Pulsed Radiofrequency for Cervical Nerve Roots Injection in Refractory Chronic Unilateral Cervical Radicular Pain
Primary Purpose
Chronic Cervical Radiculopathy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
radiofrequency ablation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Cervical Radiculopathy
Eligibility Criteria
Inclusion Criteria: Age between 20 and 80 years with presence of ≥ 2 months history of neck pain radiating to the arm despite good conservative treatment. Unilateral pain and one level disc prolapse. ≥ 50% temporary pain relief following a diagnostic nerve block with 1 mL of 2% lidocaine 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group H ( high voltage) radiofrequency
Group S ( standard) radiofrequency
Arm Description
Outcomes
Primary Outcome Measures
numeric rating scale
pain score assessment ( 0 to ten score, score <3 means no or mild pain while score between 4-6 equals moderate pain, score > 6 means severe disabling pain)
Secondary Outcome Measures
Neck disability index
1- the impact of treatment on the Neck Disability Index which was evaluated before treatment and at 6 months following treatment
complications
cervical epidural hematoma, nerve injury
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05749185
Brief Title
High Versus Standard Voltage Pulsed Radiofrequency for Cervical Nerve Roots Injection in Refractory Chronic Unilateral Cervical Radicular Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 22, 2023 (Anticipated)
Primary Completion Date
October 12, 2023 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Patients with refractory cervical radiculopathy can get benefit from radiofrequency ablation using specific voltage current to obtund chronic brachialgia. We will compare standard versus supra-voltage current in the efficacy of ablation using numeric rating scale as a primary outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cervical Radiculopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group H ( high voltage) radiofrequency
Arm Type
Active Comparator
Arm Title
Group S ( standard) radiofrequency
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
radiofrequency ablation
Intervention Description
radiofrequency ablation
Primary Outcome Measure Information:
Title
numeric rating scale
Description
pain score assessment ( 0 to ten score, score <3 means no or mild pain while score between 4-6 equals moderate pain, score > 6 means severe disabling pain)
Time Frame
6 month after intervention
Secondary Outcome Measure Information:
Title
Neck disability index
Description
1- the impact of treatment on the Neck Disability Index which was evaluated before treatment and at 6 months following treatment
Time Frame
6 months
Title
complications
Description
cervical epidural hematoma, nerve injury
Time Frame
6 hours after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 20 and 80 years with presence of ≥ 2 months history of neck pain radiating to the arm despite good conservative treatment. Unilateral pain and one level disc prolapse.
≥ 50% temporary pain relief following a diagnostic nerve block with 1 mL of 2% lidocaine
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.
12. IPD Sharing Statement
Learn more about this trial
High Versus Standard Voltage Pulsed Radiofrequency for Cervical Nerve Roots Injection in Refractory Chronic Unilateral Cervical Radicular Pain
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