Chronic Thoracic Back PainNCT02073292
Cooled Radiofrequency Ablation vs. Thermal Radiofrequency Ablation
A study testing c-RFA and tRFA in people with Chronic Thoracic Back Pain, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Thoracic Back Pain
- What is being tested?
- c-RFA and tRFA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing Thermal and Cooled Radiofrequency Ablation Techniques of Thoracic Facets' Medial Branches to Manage Thoracic Pain
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.
Read more
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.
- Conditions
- Chronic Thoracic Back Pain
- Being tested
- c-RFA, tRFA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
c-RFAProcedure or surgery
tRFAProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| c-RFA | Experimental | cooled radiofrequency ablation Receives: Procedure: c-RFA |
| t-RFA | Active comparator | thermal radiofrequency ablation Receives: Procedure: tRFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score on the visual analogue scale
Measured: Change from baseline in pain at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startMar 2014
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Thoracic Back PainStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Kimberly-Clark Corporation
- Responsible party
- Sponsor
- Investigators
- Nagy Mekhail, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073292
- Sponsor's protocol ID
- 13-1073
- Status last verified
- Feb 2023
- First submitted
- 21 Feb 2014
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Thermal and Cooled Radiofrequency Ablation Techniques of Thoracic Facets' Medial Branches to Manage Thoracic Pain
- ClinicalTrials.gov ID
- NCT02073292
- Acronym / sponsor ID
- 13-1073
- Conditions
- Chronic Thoracic Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Kimberly-Clark Corporation
- Study start
- Mar 2014 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 27 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| c-RFA | Experimental | Procedure: c-RFAcooled radiofrequency ablation |
| t-RFA | Active comparator | Procedure: tRFAthermal radiofrequency ablation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| c-RFA | Procedure or surgery | c-RFA |
| tRFA | Procedure or surgery | t-RFA |
Primary outcome
Pain Score on the visual analogue scale
Time frame: Change from baseline in pain at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nagy Mekhail principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing c-RFA and tRFA in people with Chronic Thoracic Back Pain, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score on the visual analogue scale (time frame: Change from baseline in pain at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.