Chronic Cervical Radiculopathy
Conditions
Brief 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.
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)
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual analogue score | 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
| Measure | Time frame | Description |
|---|---|---|
| Neck disability index | 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 | 6 hours after the procedure | cervical epidural hematoma, nerve injury |
Countries
Egypt
Outcome results
None listed