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Effect of the Temperature Used in Thermal Radiofrequency Ablation

NCT02148003 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2024-03-19

Study results available
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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.

Conditions

  • Low Back Pain

Interventions

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.

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Nagy Mekhail, MD, PhD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2022-05-31
Completion
2022-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02148003 on ClinicalTrials.gov