NCT02148003

Effect of the Temperature Used in Thermal Radiofrequency Ablation

Effect of the Temperature Used in Thermal Radiofrequency Ablation on Outcomes of Lumbar Facets Medial Branches Denervation Procedures: A Randomized Double-Blinded Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will determine if lumbar facets medial branches RFA at 90 degrees Celsius provides more overall pain relief (i.e., percent of improvement), when compared to ablation at 80 degrees Celsius with no additional adverse events.

Detailed description

Chronic lower back pain (CLBP) is a significant health care issue in the United States and the world. CLBP contributes to decreased quality of life, decreased function and increased utilization of health care resources. The causes of CLBP tend to be multi-factorial. Arthropathy of the lumbar facet joints is thought to be a common etiology (15-45%). Radiofrequency Ablation (RFA) of the medial branch nerve of the facet joint is a well-established treatment modality used to decrease facet joint pains. However, a wide range of temperature is being used (70-90 degrees Celsius). In addition, the optimal temperature that provides the best patient outcomes with the least side effects is not well established in the pain management literature. This study will determine if lumbar facets medial branches RFA at 90 degrees Celsius provides more overall pain relief (i.e., percent of improvement), when compared to ablation at 80 degrees Celsius with no additional adverse events. Furthermore, ablation of the lumbar facets nerve supply at 90 degrees Celsius will provide better improvement in the functionality level, general mood and quality of life as measured by VAS ( Visual Analog Scale) pain score, Pain Disability Index (PDI), McGill Pain questioner scores and Beck Inventory (BI) scores as those receiving the ablation at 80 degrees Celsius. Also, it is associated with less opioid consumption, no additional unwanted adverse events and/or complications along with less need to repeat RFA procedure over one year period.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
PROCEDURE	RFA at 90 degrees Celsius	Ablation at 90 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 90 degrees Celsius
PROCEDURE	RFA at 80 degrees Celsius	Ablation at 80 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 80 degrees Celsius
DEVICE	C-arm guided 20-gauge radiofrequency needle	Needles will be adjusted to optimize sensory and motor stimulation.

Timeline

• Start date: 2014-05-01
• Primary completion: 2022-05-01
• Completion: 2022-09-01
• First posted: 2014-05-28
• Last updated: 2024-03-19
• Results posted: 2024-03-19

Locations

1 site across 1 country: United States