Low Back PainNCT02148003
Effect of the Temperature Used in Thermal Radiofrequency Ablation
A study testing RFA at 90 degrees Celsius, RFA at 80 degrees Celsius and C-arm guided 20-gauge radiofrequency needle in people with Low Back Pain, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- RFA at 90 degrees Celsius, RFA at 80 degrees Celsius and C-arm guided 20-gauge radiofrequency needle
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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.
- Conditions
- Low Back Pain
- Being tested
- RFA at 90 degrees Celsius, RFA at 80 degrees Celsius, C-arm guided 20-gauge radiofrequency needle
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFA at 90 degrees CelsiusProcedure or surgery
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 80 degrees CelsiusProcedure or surgery
Ablation at 80 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 80 degrees Celsius
C-arm guided 20-gauge radiofrequency needleDevice
Needles will be adjusted to optimize sensory and motor stimulation.
| Study group | Role | What they receive |
|---|---|---|
| RFA at 90 degrees Celsius | Active comparator | Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 90 degrees Celsius Receives: 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 Receives: Procedure: RFA at 80 degrees Celsius; Device: C-arm guided 20-gauge radiofrequency needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2022
- Study completionSep 2022
Why it stopped: Study terminated by Principal Investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nagy Mekhail, MD, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148003
- Sponsor's protocol ID
- 13-1470
- Status last verified
- Feb 2024
- First submitted
- 22 Apr 2014
- Last updated
- 19 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02148003
- Acronym / sponsor ID
- 13-1470
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated by Principal Investigator
- Enrolment
- 199 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- May 2022 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Posted 19 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFA at 90 degrees Celsius | Active comparator | Procedure: RFA at 90 degrees Celsius, Device: C-arm guided 20-gauge radiofrequency needleRadiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 90 degrees Celsius |
| RFA at 80 degrees Celsius | Active comparator | Procedure: RFA at 80 degrees Celsius, Device: C-arm guided 20-gauge radiofrequency needleRadiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 80 degrees Celsius |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| RFA at 90 degrees CelsiusAblation at 90 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 90 degrees Celsius | Procedure or surgery | RFA at 90 degrees Celsius |
| RFA at 80 degrees CelsiusAblation at 80 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 80 degrees Celsius | Procedure or surgery | RFA at 80 degrees Celsius |
| C-arm guided 20-gauge radiofrequency needleNeedles will be adjusted to optimize sensory and motor stimulation. | Device | RFA at 80 degrees Celsius, RFA at 90 degrees Celsius |
Primary outcome
Visual Analog Scale (VAS) Pain Score 30-day After Procedure
Time frame: 30 days after the 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, MD, PhD 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 RFA at 90 degrees Celsius, RFA at 80 degrees Celsius and C-arm guided 20-gauge radiofrequency needle in people with Low 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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 19 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 19 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analog Scale (VAS) Pain Score 30-day After Procedure (time frame: 30 days after the procedure). 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 19 Mar 2024.