Cooled Radiofrequency Ablation vs. Thermal Radiofrequency Ablation
CompletedNot applicableNCT02073292
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 p…
Study details
- Official title
- A Randomized Controlled Trial Comparing Thermal and Cooled Radiofrequency Ablation Techniques of Thoracic Facets' Medial Branches to Manage Thoracic Pain
- Conditions
- Chronic Thoracic Back Pain
- Interventions
- Procedure: c-RFA
- Procedure: tRFA
- Sponsor
- The Cleveland Clinic
- Collaborators
- Kimberly-Clark Corporation
- Start date
- 2014-03
- Primary completion
- 2022-12-15
- Sex
- All
- Age range
- from 18 Years to 90 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02073292