Impact OF Cooled Versus Thermal Radiofrequency Denervation In Management Of Chronic Lumber Facet Joint Pain

Zagazig University

Status: Enrolling

Conditions: Lumber Facet Joint Pain(Lower Back Pain ) Relief by Cooled Radiofrequency or Thermal Radiofrequency Denervation

Treatments: Device: Cooled Radiofrequency denervation; Device: thermal radio frequency denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT07309731

1788/2-Nov-2025

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient's acceptance .

• Both sexes (male and female).

• Age between 30 and 70 years .

• Physical status; ASA I , II. (American society of anesthesiologist)

• BMI; 22-30 Kg/m2.

• Presence of

  1. Chronic Lumbar Facet Joint Pain (numerical rating scale (NRS) ≥ 6) lasting for 3 months or more without any response to noninvasive conservative treatment methods like NSAIDs and gabapentin therapy for pain control, or physiotherapy,
  2. Patients have two to three levels of bilateral facet arthropathy with normal motor power of lower extremities
  3. Local paraspinal tenderness with increased pain on hyperextension, rotation, or lateral bending of the lower lumbar spine.

• More than or equal to 50% temporary pain relief following an ultrasound guided diagnostic medial branch block with local anesthetic corticosteroid injection.

Exclusion criteria

• 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.
• Coagulopathy, bleeding disorders .
• Allergy to medications or contrast to be used .
• Rheumatic disorders.
• Systemic infections, or local infections in the field of intervention .
• Any uncontrolled medical or psychiatric condition .
• Pregnancy, lactating women .

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

thermal radio frequency denervation (T) group

Active Comparator group

Description:

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 (volt), the frequency 2 Hz for 120 s, three cycles with rotation of the needle each time. At the end of the radiofrequency(RF)procedure, after the probe is removed , 20 mg methylprednisolone acetate will be given through the RF needle for each level

Treatment:

Device: thermal radio frequency denervation

Cooled Radiofrequency denervation (C) group

Active Comparator group

Description:

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 (cooled radio frequency ablation) 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 generator temperature set to 60°C (intralesional temperature \>80°) for 150 seconds for each

Treatment:

Device: Cooled Radiofrequency denervation