NCT07309731 Impact OF Cooled Versus Thermal Radiofrequency Denervation In Management Of Chronic Lumber Facet Joint Pain
| NCT ID | NCT07309731 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zagazig University |
| Condition | Lumber Facet Joint Pain(Lower Back Pain ) Relief by Cooled Radiofrequency or Thermal Radiofrequency Denervation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-01-15 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 .
Contact & Investigator
khadeja m elhossieny, MD
PRINCIPAL INVESTIGATOR
Zagazig University
Frequently Asked Questions
Who can join the NCT07309731 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 70 Years, studying Lumber Facet Joint Pain(Lower Back Pain ) Relief by Cooled Radiofrequency or Thermal Radiofrequency Denervation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07309731 currently recruiting?
Yes, NCT07309731 is actively recruiting participants. Contact the research team at mervatassy@yahoo.com for enrollment information.
Where is the NCT07309731 trial being conducted?
This trial is being conducted at Zagazig, Egypt, Zagazig, Egypt.
Who is sponsoring the NCT07309731 clinical trial?
NCT07309731 is sponsored by Zagazig University. The principal investigator is khadeja m elhossieny, MD at Zagazig University. The trial plans to enroll 100 participants.