Effect of the Temperature Used in Thermal Radiofrequency Ablation

NCT02148003 | Terminated Results

• 1 other identifier: 13-1470
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

RFA at 90 degrees Celsius

ACTIVE COMPARATOR

Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 90 degrees Celsius

Procedure: RFA at 90 degrees Celsius; Device: C-arm guided 20-gauge radiofrequency needle

RFA at 80 degrees Celsius

ACTIVE COMPARATOR

Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 80 degrees Celsius

Procedure: RFA at 80 degrees Celsius; Device: C-arm guided 20-gauge radiofrequency needle

Interventions

RFA at 90 degrees Celsius PROCEDURE

Ablation at 90 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 90 degrees Celsius

RFA at 90 degrees Celsius

RFA at 80 degrees Celsius PROCEDURE

Ablation at 80 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 80 degrees Celsius

RFA at 80 degrees Celsius

C-arm guided 20-gauge radiofrequency needle DEVICE

Needles will be adjusted to optimize sensory and motor stimulation.

RFA at 80 degrees Celsius; RFA at 90 degrees Celsius

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nagy Mekhail, MD
• Organization: Cleveland Clinic

mekhain@ccf.org

216 444-9114

Study Officials

• Nagy Mekhail, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: May 28, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 19, 2024
• Results First Posted: March 19, 2024

Record last verified: 2024-02

Locations

US (1)