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Cooled Radiofrequency Ablation vs. Thermal Radiofrequency Ablation

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ClinicalTrials.gov Identifier: NCT02073292
Recruitment Status : Recruiting
First Posted : February 27, 2014
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
Kimberly-Clark Corporation
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:

Nerves in your body transmit signals to and from your brain and the cells in your body. In the event of an injury or disease, these nerves transmit pain. Sometimes, when an injury doesn't heal, chronic pain can develop. One way to treat chronic pain is to interrupt these pain signals. One method of doing this is to use Radio frequency ablation (RFA).

Radio frequency ablation (RFA) is a medical procedure in which heat is generated from high frequency electrical current in order to lesion (burn) nervous tissue. Radiofrequency ablation is used to treat many conditions in several areas of the body including cardiac (heart) as well as chronic pain. Probes (needles) are inserted into the body to a specific location and the electrical current is passed through these needles. This electrical current creates heat in your body and forms small lesions or burns in a specific place. Doctors will use tools, such as fluoroscopy (x-rays) and injections to locate the specific nerves that are transmitting pain and then use the electrical current to destroy those nerves.

Equipment used include generator, built in nerve stimulator, different needles and probes and water cooling system in case of the cooled RFA.

There are several types of probes or needles that are used to transmit energy and create lesions. This study is going to compare 2 types - standard radiofrequency and 'cooled' radiofrequency. The only difference is that the 'cooled' radiofrequency probes have water running through the probe tip, which keeps the tip cool and allows a larger lesion to be made. Since the doctor can't actually see the nerve he is trying to target, the larger lesion should theoretically improve his chances of hitting it. The 'cooling' of the water also allows the temperatures to be lower than what is needed for standard RF. In this study, the investigators would like to compare the differences between standard RFA (90°C) and "cooled" RFA (60°C) ablation techniques and determine if one is better for pain relief.

All of the probes that are used to perform radiofrequency ablation are FDA approved and are commonly used to treat patients with chronic back pain.

Participating in the study involves being randomly assigned to received either standard or cooled RFA. The procedure for both standard and cooled RFA is basically the same. The only difference is with standard RFA, the doctor may perform up to 2 lesions, instead of 1 if they are using cooled RFA.

Both study groups will receive local anesthetic prior to procedure. The treating doctor will use a machine called a C-Arm to take x-rays. These x-rays will guide the doctor to be sure the probes are in the right place. Once the probe placement is confirmed, the doctor will turn on the generator and create the lesion. This process will be repeated depending on how many lesions need to be created.

After the procedure there will be follow up visits at 1, 3 and 6 months. Level of pain, health and recovery information will be collected.


Condition or disease Intervention/treatment Phase
Chronic Thoracic Back Pain Procedure: c-RFA Procedure: tRFA Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Thermal and Cooled Radiofrequency Ablation Techniques of Thoracic Facets' Medial Branches to Manage Thoracic Pain
Study Start Date : March 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: c-RFA
cooled radiofrequency ablation
Procedure: c-RFA
Active Comparator: t-RFA
thermal radiofrequency ablation
Procedure: tRFA



Primary Outcome Measures :
  1. Pain Score on the visual analogue scale [ Time Frame: Change from baseline in pain at 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Chronic thoracic spine mediated back pain of 3 months duration or longer
  • Absence of focal neurologic signs or symptoms related to thoracic radiculopathy
  • Failure to respond to conservative measures in the form of oral medication and physical therapy
  • More than 50% reduction in their pain less than 2 months duration following a series of 2 diagnostic thoracic medial branch blocks of the affected joints using 1 ml of 1% lidocaine in the first procedure and bupivacaine 0.5 % in the second time

Exclusion Criteria:

  • Untreated coagulopathy
  • Concomitant medical (e.g. uncontrolled cardiac condition) or psychiatric illness (e.g., untreated depression) likely to endanger the patient or compromise treatment outcomes
  • Pregnancy
  • Malignancy
  • Systemic or local infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02073292


Contacts
Contact: Nagy Mekhail 1-216-445-8396 mekhain@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Kimberly-Clark Corporation
Investigators
Principal Investigator: Nagy Mekhail The Cleveland Clinic

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02073292     History of Changes
Other Study ID Numbers: 13-1073
First Posted: February 27, 2014    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms