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

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.

Study Overview

• Status: Terminated
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: RFA at 90 degrees Celsius; Device: C-arm guided 20-gauge radiofrequency needle; Procedure: RFA at 80 degrees Celsius

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.

• Study Type: Interventional
• Enrollment (Actual): 199
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >18 years-old
• Subjects who are able to give informed consent and to understand and comply with study requirements.
• Predominantly axial low back pain ≥ 3 months in duration with no radicular pain below the knee that failed to conservative therapy.
• Subjects who have chronic back pain attributed to lumbar facet joints arthropathy based on clinical evaluation (paraspinal tenderness and/or facet loading test in the absence of signs and symptoms suggestive of focal neurological deficits).
• No history of previous back surgery at the intended treatment levels.
• Adequate response to the diagnostic blocks without the use of steroids at the same levels of the intended block (Defined as ≥ 75% pain relief).
• Patients who will undergo RFA of 3-4 lumbar facet medial branches on one side only.

Exclusion Criteria:

• Subjects who decline to provide written consent or follow-up.
• Subjects who have a history of adverse reactions to local anesthetic.
• Subjects who are pregnant.
• Subjects with bleeding disorders or active anticoagulation that cannot be stopped for few days close to the time of the procedure.
• Subjects who have an active systemic or local infection.
• Presence of radicular pain below the knee.
• Patients who have other specific etiology of low back pain (e.g. significant spinal canal stenosis or grade 2 or 3 spondylolisthesis).
• Secondary gain (i.e., ongoing litigation, worker's compensation or other financial incentives)
• Psychopathology including depression, somatization or poor coping skills
• Physical factors including non-sedentary lifestyle, e.g.; morbid obesity (BMI > 35kg/m2).
• History of previous RFA at the same level(s) in the previous 12 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RFA at 90 degrees Celsius; Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 90 degrees Celsius	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; Device: C-arm guided 20-gauge radiofrequency needle; Needles will be adjusted to optimize sensory and motor stimulation.
Active Comparator: RFA at 80 degrees Celsius; Radiofrequency ablation (RFA) 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.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) Pain Score 30-day After Procedure	The primary outcome was the Visual Analog Scale (VAS) pain score at 30-day follow-up visit, which was collected by patients marking a position on a strip to indicate the intensity of their pain. The locations patients marked are translated into a score from 0-100, with 0 being no pain and 100 corresponding to the worst imaginable pain.	30 days after the procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of repeats of procedure	1 year

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Nagy Mekhail, MD, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: April 22, 2014
• First Submitted That Met QC Criteria: May 23, 2014
• First Posted (Estimated): May 28, 2014

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 13-1470