Low Back Pain
Conditions
Brief 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.
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.
Interventions
PROCEDURERFA at 90 degrees Celsius
Ablation at 90 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 90 degrees Celsius
PROCEDURERFA at 80 degrees Celsius
Ablation at 80 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 80 degrees Celsius
DEVICEC-arm guided 20-gauge radiofrequency needle
Needles will be adjusted to optimize sensory and motor stimulation.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Pain Score 30-day After Procedure | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RFA at 90 Degrees Celsius Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 90 degrees Celsius
RFA at 90 degrees Celsius: Ablation at 90 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 90 degrees Celsius
C-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation. | 59 |
| RFA at 80 Degrees Celsius Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 80 degrees Celsius
RFA at 80 degrees Celsius: 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 needle: Needles will be adjusted to optimize sensory and motor stimulation. | 58 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Failed inclusion criteria | 1 | 0 |
| Overall Study | Met exclusion criteria | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | RFA at 90 Degrees Celsius | RFA at 80 Degrees Celsius |
|---|---|---|---|
| Age, Continuous | 58 year STANDARD_DEVIATION 13 | 57 year STANDARD_DEVIATION 13 | 61 year STANDARD_DEVIATION 14 |
| Body mass index | 28 kg/m^2 STANDARD_DEVIATION 4 | 28 kg/m^2 STANDARD_DEVIATION 4 | 28 kg/m^2 STANDARD_DEVIATION 4 |
| Diabetes history No | 99 Participants | 53 Participants | 46 Participants |
| Diabetes history Yes | 18 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 68 Participants | 34 Participants | 34 Participants |
| Sex: Female, Male Male | 49 Participants | 25 Participants | 24 Participants |
| Smoking history No | 83 Participants | 40 Participants | 43 Participants |
| Smoking history Yes | 34 Participants | 19 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 58 |
| other Total, other adverse events | 0 / 59 | 0 / 58 |
| serious Total, serious adverse events | 0 / 59 | 0 / 58 |
Outcome results
Primary
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.
Time frame: 30 days after the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RFA at 90 Degrees Celsius | Visual Analog Scale (VAS) Pain Score 30-day After Procedure | 50.4 units on a scale | Standard Deviation 31.4 |
| RFA at 80 Degrees Celsius | Visual Analog Scale (VAS) Pain Score 30-day After Procedure | 47.2 units on a scale | Standard Deviation 30.5 |