Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05719948 |
| Other study ID # |
R 333 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2020 |
| Est. completion date |
February 1, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Fayoum University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Continuous radiofrequency ablation (CRF) is the effective management for cervical facet joint
pain but related with neuropathic symptoms in post-radiofrequency period. Additionally, pulse
radiofrequency ablation (PRF) provides relief of neuropathic symptoms. However, the effect of
CRF followed by PRF has yet to be validated
Description:
Diagnostic procedure symptomatic facet joint was designated according to pain referral. Also,
medial branches were injected with 2% lidocaine 0.3 ml per site.
Treatment procedure The posterior technique was first described in 1995 . All interventions
assessed the intravenous saline lock on arrival at the outpatient department using pulse
oximetry and noninvasive blood pressure monitoring and intravenous sedation as required.
Patients were assigned in a prone position under C-ARM fluoroscopic guidance with a
Neurotherm NT 2000 Lesion Generator the (USA manufactured) . The electrode pad of the
radiofrequency equipment was attached to the ipsilateral side of the posterior thigh. After
the skin was then anesthetized with 1% lidocaine, a 20-gauge, 10-cm cannula with 10-mm curved
active tip (Diros RF Cannula, Diros Technology Inc., Canada) was inserted along a 15 to 30
degree angle to the sagittal plane (slightly posterior oblique approach) . The cannula was
applied until reaching the lateral part of the articular pillar . Then the depth of the
cannula was checked using a lateral view. A probe was inserted through the cannula and linked
to a radiofrequency generator (Diros Technology OWL, Canada). After impedance were
accomplished at below 500 Ohm, sensory stimulation was performed at 50 Hz and the patient
reported not feeling any tingling sensation along the distribution of dermatome.
Consequently, a motor stimulation (2 Hz) was executed until multifidus twitching was
presented at stimulation less than 1 volts and no motor twitching was observed along the
myotome. A non-ionic contrast medium was injected to ensure the intravascular injection
before 1% lidocaine 0.5 ml was injected after the needle reached the desired location. The
study investigated two lesions due to the anatomical variation of the medial branches.
Patients in the CRF group (n = 16) underwent CRF at 80°C for 90 seconds for 2 cycles.
Patients in the CPRF group underwent CRF at 80°C for 90 seconds for 1 cycle followed by PRF
at 42°C for 120 seconds for 1 cycle. 0.125% bupivacaine plus 2 mg of dexamethasone in a total
volume of 1 mL were injected after lesioning had performed.
Measurement The demographic data including age, sex, comorbidities, body mass index (BMI),
level of procedure, visual analog scale (VAS;1-100) Neck Pain Disability Index and
complications were reviewed. It contains ten sectors: seven sectors related to everyday
existing behaviors, two sectors correlated to pain, and one sector correlated to
concentration. All items are marked from 0 to 5. A mark of 0 denotes the maximum level of
function, while a mark of 5 indicates the bottom level of function. The maximum mark is 50,
and a greater mark relates to an increased level of disability. The NDI scores were recorded
before intervention and first month, third month, sixth month, ninth months and 12 months
after intervention. The follow-up was performed either face to face or by phone, and patients
were not permitted to use over-the counter analgesic medication. The primary outcome was
number of patients who had successful treatment, expressed as at least 80% pain relief from
baseline and NDI score less than 15 for at least 3 months . The secondary outcomes comprised
the duration of pain relief defined as the time of pain relief until VAS had restored to at
least 50% from baseline and side effects including numbness, ataxia, dysesthesia,
hypersensitivity, itching and muscular weakness (dropped head syndrome) between group
comparisons. A research assistant, who was uninvolved in the intervention or post-operative
follow-up, collected all data in prospective medical records.
