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Effect of the Temperature Used in Thermal Radiofrequency Ablation

Primary Purpose

Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

RFA at 90 degrees Celsius

RFA at 80 degrees Celsius

C-arm guided 20-gauge radiofrequency needle

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 ≥ 70% 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.

Sites / Locations

Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

RFA at 90 degrees Celsius

RFA at 80 degrees Celsius

Arm Description

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

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

Outcomes

Primary Outcome Measures

Assessing a change of pain relief

Secondary Outcome Measures

Number of repeats of procedure

Full Information

NCT ID

NCT02148003

First Posted

April 22, 2014

Last Updated

April 3, 2023

Sponsor

The Cleveland Clinic

1. Study Identification

Unique Protocol Identification Number

NCT02148003

Brief Title

Effect of the Temperature Used in Thermal Radiofrequency Ablation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

May 2014 (Actual)

Primary Completion Date

May 2022 (Actual)

Study Completion Date

September 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Cleveland Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

144 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RFA at 90 degrees Celsius

Arm Type

Active Comparator

Arm Description

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

Arm Title

RFA at 80 degrees Celsius

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

RFA at 90 degrees Celsius

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

RFA at 80 degrees Celsius

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

C-arm guided 20-gauge radiofrequency needle

Intervention Description

Needles will be adjusted to optimize sensory and motor stimulation.

Primary Outcome Measure Information:

Title

Assessing a change of pain relief

Time Frame

12 Months

Secondary Outcome Measure Information:

Title

Number of repeats of procedure

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nagy Mekhail, MD, PhD

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

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Effect of the Temperature Used in Thermal Radiofrequency Ablation

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