Impact OF Cooled Versus Thermal Radiofrequency Denervation In Management Of Chronic Lumber Facet Joint Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-70
SponsorZagazig University
About this trial
Chronic lumber facet joint pain is defined according to international association of study of pain (IASP)as multifactorial phenomenon of pain that persist more than 3 months after an injury and /or beyond the usual course of an acute lumber facet pain or a reasonable time for a comparable injury to heal .
lumber facet joint degeneration (LRFJ) is the 1st source of chronic low back pain with an incidence of 15% t o 45 % among patients with low back pain . the spinal facet joint has an abundant nerve supply ; therefore, pain can be caused by arthritic change, degenerative change, inflammation, and injury .
Degeneration of all LFJs (lumbar facet joints) was diagnosed using magnetic resonance image (MRI) , the most sensitive and diagnostic tool. Thus, hypertrophy, degeneration, and the accumulation of fluid within the joints are signs of LFJ degeneration it was found in all treated LFJs .
facet joint pain management can be achieved using medical therapy or facet joint therapeutic interventions, ultrasound guided injection,or fluoroscopically guided facet joint injection (FJI) , medial branch block (MBB) , or radiofrequency ablation .
Radiofrequency is a minimally invasive procedure and is operated under light
intravenous sedation or local anesthesia when necessary. Radiofrequency
energy is delivered to the target nerves through an insulated needle , and this
energy heats and denatures the nerve for the purpose of pain relief . The
radiofrequency techniques include, thermal, and cooled radiofrequency .
thermal radiofrequency (TRFA) uses more energy and higher temperature compared
with cooled radiofrequency , cooled radiofrequency ablation (CRFA) is a
newer technique, and may have some theoretical advantages over traditional
radiofrequency whereas , cooled radiofrequency adopts internally probes to
increase lesion size , and it can increase the chance of complete denervation .
based on heat neurotomy (60°C (celsius) vs. 80°C in TRFA) with the resulting ablative area twice as long and extending distally from the tip of the electrode.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient's acceptance .
Both sexes (male and female).
Age between 30 and 70 years .
Physical status; ASA I , II. (American society of anesthesiologist)
Disqualifiers
Those with spondylolisthesis or disc herniation or internal disc disruption (IDD).
Previous spinal surgery at the level to be treated , Spinal canal stenosis or spinal instability.
Patient with previous radiofrequency ablation.
Patients having radicular pain, neurogenic claudication, or neurological deficits.
Trial design
Design model
Parallel
Treatments tested in this trial
thermal radio frequency denervation
DeviceThe medial branch of the dorsal spinal ramus is the main target .The fluoroscopy will be then placed at slightly oblique view . An 22-gauge insulated RF needle with 1 cm active tip will be used .the parameters of Radiofrequency Denervation treatment are : the tip temperature being at 80 °C, 45V, the frequency 2 Hz for 120 s, three cycles with rotation of the needle each time. At the end of the RF procedure, after the probe is removed , 20 mg methylprednisolone acetate will be given through the RF needle for each level
Cooled Radiofrequency denervation
DevicePatients will positioned prone with a C-arm fluoroscopy. 22-gauge spinal needles were placed in the appropriate location as lumbar medial branch blocks in Spinal Intervention Society Guidelines . 17-gauge 4 mm active tipped CRFA electrodes were used for the procedure . The CRFA electrodes were also placed in the appropriate location similar to described as lumbar medial branch blocks procedure, instead of traditional placement of electrodes described as in Spinal Intervention Society Guidelines.The RFA (radio frequency ablation) generator temperature set to 60°C (intralesional temperature \>80°) for 150 seconds for each
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: thermal radio frequency denervation (T) groupActive comparator 1 intervention
Group B: Cooled Radiofrequency denervation (C) groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in pain intensity
using a numerical rating scale (NRS) ranging from 0 to 10 (0: "no pain" to 10: "the worse pain")
Time frame
NRS will be detected and recorded immediately 2 hours post intervention and then at 1 week , 1 month , 3 months, and 6 months after intervention .Sponsors and contacts
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Source ClinicalTrials.gov