Cooled versus thermal radiofrequency denervation for chronic lumbar facet joint pain

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

This trial will test cooled versus thermal radiofrequency denervation to see which reduces chronic lumbar facet joint pain in adults who haven't improved with medicines or physical therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 30 Years to 70 Years
• Sex: All
• Sponsor: Zagazig University (Government)
• Locations: 2 sites (Zagazig, Elsharqya and 1 other locations)
• Trial ID: NCT07309731 on ClinicalTrials.gov

What this trial studies

This interventional comparison enrolls adults aged 30–70 with MRI-confirmed lumbar facet joint degeneration and severe chronic pain who had ≥50% temporary relief from a diagnostic medial branch block. Eligible participants receive either cooled radiofrequency (CRF) or conventional thermal radiofrequency (TRF) denervation at the affected facet levels, with procedures performed under image guidance. Outcomes include changes in numerical pain rating (NRS), functional status, and need for repeat procedures over scheduled follow-up visits. Key exclusions are spondylolisthesis, disc herniation/internal disc disruption, or prior spinal surgery at the treated level.

Who should consider this trial

Good fit: Adults 30–70 with chronic lumbar facet joint pain (NRS ≥6) unresponsive to conservative care, MRI evidence of facet degeneration at two to three bilateral levels, normal lower-extremity motor power, and ≥50% relief from a diagnostic medial branch block.

Not a fit: People with spondylolisthesis, disc herniation or internal disc disruption, prior spinal surgery at the treated level, or pain primarily from non-facet sources are unlikely to benefit from these denervation procedures.

Why it matters

Potential benefit: If successful, one technique could provide longer-lasting or more effective pain relief with fewer repeat procedures for people with lumbar facet joint pain.

How similar studies have performed: Previous trials comparing cooled and conventional radiofrequency for facet-mediated back pain have shown mixed but generally favorable results, with some evidence that cooled RF can provide longer pain relief though findings are not uniformly conclusive.

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 .

Where this trial is running

Zagazig, Elsharqya and 1 other locations

• Faculty of Medicine,Zagazig University — Zagazig, Elsharqya, Egypt (Recruiting)
• Faculty of Medicine,Zagazig University — Zagazig, Elsharqya, Egypt (Recruiting)

Study contacts

• Principal investigator: khadeja m elhossieny, MD — Zagazig University
• Study coordinator: manal M rashad, MD

Conditions Lumber Facet Joint Pain Relief by Cooled Radiofrequency or Thermal Radiofrequency Denervation