Impact OF Cooled Versus Thermal Radiofrequency Denervation In Management Of Chronic Lumber Facet Joint Pain
NCT07309731 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-01-06
Summary
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.
Conditions
- Lumber Facet Joint Pain(Lower Back Pain ) Relief by Cooled Radiofrequency or Thermal Radiofrequency Denervation
Interventions
- DEVICE
-
thermal radio frequency denervation
The 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
- DEVICE
-
Cooled Radiofrequency denervation
Patients 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
Sponsors & Collaborators
-
Zagazig University
lead OTHER_GOV
Principal Investigators
-
khadeja m elhossieny, MD · Zagazig University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-15
- Primary Completion
- 2026-04-01
- Completion
- 2026-10-01
Countries
- Egypt
Study Locations
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