Low Back Pain, Facet Joint Pain
Conditions
Keywords
low back pain
Brief summary
This is a single-center, randomized, pilot study in adult subjects with facet mediated CLBP. Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive ioveraº medial branch cryoneurolysis or radiofrequency ablation.
Detailed description
This is a single-center, randomized, pilot study in adult subjects with facet mediated CLBP. Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive ioveraº medial branch cryoneurolysis or radiofrequency ablation. This study is designed to determine if a full efficacy RCT can be successfully conducted using the procedures and protocols described in the current pilot study protocol, or if protocol modifications are necessary before moving forward with a full efficacy RCT. Furthermore, the study will assess the feasibility of the outcome measurements employed, construct a foundation for sample size calculation, and the acceptability/practicality of conducting the full efficacy RCT. Randomization to treatment groups according to the randomization assignment will be performed on the day of treatment. The treatment groups are: * Group 1: subjects will receive iovera° cryoneurolysis to the medial branch nerves of the lumbar spine * Group 2: subjects will receive RFA to the medial branch nerves of the lumbar spine
Interventions
DEVICEiovera system
The iovera° system consists of a reusable, portable Handpiece, along with single patient use sterile Smart Tips (i.e., cryoprobes) and disposable nitrous oxide (N2O) cartridges. The iovera° system produces the desired effect through initiation of a cooling cycle. Each cooling cycle is initiated by fully inserting the Smart Tip into the selected procedure site and activating the cryogen flow. The Smart Tip needles are made of stainless steel and have a closed tip, fully enclosing the cryogen. The 190 Smart Tip will be used in this study.
DEVICERadiofrequency ablation
The RFA system consists of a Cosman, G4 Generator. The needles used are 20-gauge, 10cm long with a 10mm active tip manufactured by Cosman. A grounding pad, also manufactured by Cosman, is placed on the upper thigh for each procedure and connected to the G4 Generator.
Sponsors
Pacira Pharmaceuticals, Inc
Medical Pain Management Services, PLLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label
Intervention model description
Randomization to treatment groups according to the randomization assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female volunteers, at least 18 years of age at screening 2. Primary complaint of axial low-back pain suggestive of unilateral or bilateral facet joint involvement (i.e., facet mediated CLBP) 3. Low back pain is chronic (i.e., \> 3 months' duration) 4. Low back pain score of ≥ 4 (i.e., moderate pain) on the 0 to 10 NRS or functional impairment at screening 5. Successful trial of two diagnostic medial branch blocks consisting of two positive blocks with local anesthetic only (i.e., no steroids) that results in at least 50% relief of primary (index) pain for the duration of the local anesthetic used or history of a positive response to prior radiofrequency treatment (i.e., ≥ 6 months prior to enrollment) 6. Failure of at least three months of conservative non-operative therapy (e.g., physical therapy, chiropractic care, spinal injections, NSAIDs or other appropriate analgesics), 7. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments
Exclusion criteria
1. Active workers' compensation, personal injury, Social Security disability insurance (SSDI), or other litigation/compensation related to the spine 2. Serious spinal disorders (verified on magnetic resonance imaging (MRI)) that may impact outcomes, including any of the following: 1. Suspected cauda equina syndrome (e.g., bowel/bladder dysfunction) 2. Infection 3. Tumor 4. Traumatic fracture 5. Systemic inflammatory spondyloarthropathy 6. Lumbar radiculopathy/radiculitis (i.e., root irritation and deficit) 7. Neurogenic claudication 3. Prior lumbar spinal fusion surgery 4. Comorbidity that, in the judgment of the Investigator, may affect the subject's ability to participate in the study including lumbar radiculopathy and neuropathic pain disorder 5. Currently pregnant, nursing, or planning to become pregnant during the study 6. Known contraindication to study devices, including any of the following: 1. Cryoglobulinemia 2. Paroxysmal cold hemoglobinuria 3. Cold urticaria 4. Raynaud's disease 5. Open and/or infected wounds at or near the treatment site 6. Coagulopathy 7. 3.5-inch needle cannot be used in the low back region because of habitus 8. Severe chronic pain disorder that in the opinion of the investigator may impact postsurgical outcomes 9. Presence of any of the following: 1. Spinal neurostimulator 2. Intrathecal analgesic drug pump 10. Current manifestation of poorly controlled mental illness that in the opinion of the investigator may meaningfully impact treatment outcomes, including any of the following: 1. Mood disorder (e.g., major depression, bipolar) 2. Psychotic disorder (e.g., schizophrenia) 11. Subject received other spine intervention/therapies in the 30 days prior to block administration (e.g., spinal injections, minimally invasive therapies, surgical therapies) 12. Subject received radiofrequency ablation in the low back region ≤ 6 months before study enrollment 13. History, suspicion, or clinical manifestation of: 1. Alcohol abuse or dependence 2. Illicit drug use 3. Opioid abuse or dependence (≥40 mg MED PO/day in past 30 days) Given the COVID-19 pandemic, the subject must be medically fit/cleared for treatment by the investigator. If there is a concern about a subject's recent or potential exposure to COVID-19, or if the subject is not medically fit/cleared for treatment due to suspected COVID-19 illness/symptoms (or other serious illness), the subject must be excluded per Exclusion criterion #4.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Cryoneurolysis as Compared to Radiofrequency Ablation (RFA) | 0-12 months | Safety will be assessed as the number of subjects with reported treatment-related adverse related to cryoneurolysis or RFA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity as Measured by 11-point Numeric Rating Scale (NRS) at 12 Month Follow up | 12 months | Subjects will evaluate their pain in the low back region using an 11-point Numeric Rating Scale (NRS), where 0=no pain and 10=worst possible pain. Subjects will evaluate how much pain they are currently experiencing and their average pain level over the past 24 hours. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Functional Disability Index at 12 Month Follow up | 0-12 months | Function disability will be measured by the Oswestry Disability Index. The score ranges from 0-50, with lower scores reflecting milder disability. |
| Patients' Global Impression of Change at 12 Month Follow up | 12 months | The Patients' Global Impression of Change (PGIC) is an 11-point self-report scale assessing overall changes in activity limitations, symptoms, emotions, and quality of life, ranging from 0 to 10, where higher values indicate worse outcomes. |
| Satisfaction With Pain Management | 12 months | Subject satisfaction with pain management as measured on a scale ranging from 1) extremely dissatisfied 2) dissatisfied 3) neither satisfied nor dissatisfied 4) satisfied 5) extremely satisfied. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cryoneurolysis The iovera° system consists of a reusable, portable Handpiece, along with single patient use sterile Smart Tips (i.e., cryoprobes) and disposable nitrous oxide (N2O) cartridges. The iovera° system produces the desired effect through initiation of a cooling cycle. Each cooling cycle is initiated by fully inserting the Smart Tip into the selected procedure site and activating the cryogen flow. The Smart Tip needles are made of stainless steel and have a closed tip, fully enclosing the cryogen. The 190 Smart Tip was used in this study. | 15 |
| Radiofrequency Ablation The RFA system consisted of a Cosman, G4 Generator. The needles used were 20-gauge, 10cm long with a 10mm active tip manufactured by Cosman. A grounding pad, also manufactured by Cosman was placed on the upper thigh for each procedure and connected to the G4 Generator. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Total | Cryoneurolysis | Radiofrequency Ablation |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 9 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 6 Participants | 8 Participants |
| Age, Continuous | 64.5 years STANDARD_DEVIATION 14.9 | 66.0 years STANDARD_DEVIATION 17.1 | 63.1 years STANDARD_DEVIATION 12.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 15 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| NRS | 6.1 units on a scale STANDARD_DEVIATION 1.9 | 6.1 units on a scale STANDARD_DEVIATION 1.8 | 6.1 units on a scale STANDARD_DEVIATION 1.9 |
| ODI | 18.6 units on a scale STANDARD_DEVIATION 6.4 | 18.5 units on a scale STANDARD_DEVIATION 7.1 | 18.7 units on a scale STANDARD_DEVIATION 5.9 |
| 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 | 30 Participants | 15 Participants | 15 Participants |
| Region of Enrollment United States | 30 participants | 15 participants | 15 participants |
| Sex: Female, Male Female | 14 Participants | 6 Participants | 8 Participants |
| Sex: Female, Male Male | 16 Participants | 9 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 1 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Safety of Cryoneurolysis as Compared to Radiofrequency Ablation (RFA)
Safety will be assessed as the number of subjects with reported treatment-related adverse related to cryoneurolysis or RFA.
Time frame: 0-12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cryoneurolysis | Safety of Cryoneurolysis as Compared to Radiofrequency Ablation (RFA) | 0 Participants |
| Radiofrequency Ablation | Safety of Cryoneurolysis as Compared to Radiofrequency Ablation (RFA) | 0 Participants |
Secondary
Pain Intensity as Measured by 11-point Numeric Rating Scale (NRS) at 12 Month Follow up
Subjects will evaluate their pain in the low back region using an 11-point Numeric Rating Scale (NRS), where 0=no pain and 10=worst possible pain. Subjects will evaluate how much pain they are currently experiencing and their average pain level over the past 24 hours.
Time frame: 12 months
Population: Subjects who received the study intervention and completed 12-month study follow-up.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Cryoneurolysis | Pain Intensity as Measured by 11-point Numeric Rating Scale (NRS) at 12 Month Follow up | 3.04 units on a scale | Standard Error 0.77 |
| Radiofrequency Ablation | Pain Intensity as Measured by 11-point Numeric Rating Scale (NRS) at 12 Month Follow up | 6.13 units on a scale | Standard Error 0.77 |
Other Pre-specified
Functional Disability Index at 12 Month Follow up
Function disability will be measured by the Oswestry Disability Index. The score ranges from 0-50, with lower scores reflecting milder disability.
Time frame: 0-12 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cryoneurolysis | Functional Disability Index at 12 Month Follow up | 10.15 score on a scale |
| Radiofrequency Ablation | Functional Disability Index at 12 Month Follow up | 20.61 score on a scale |
Other Pre-specified
Patients' Global Impression of Change at 12 Month Follow up
The Patients' Global Impression of Change (PGIC) is an 11-point self-report scale assessing overall changes in activity limitations, symptoms, emotions, and quality of life, ranging from 0 to 10, where higher values indicate worse outcomes.
Time frame: 12 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Cryoneurolysis | Patients' Global Impression of Change at 12 Month Follow up | 1.74 score on a scale |
| Radiofrequency Ablation | Patients' Global Impression of Change at 12 Month Follow up | 4.38 score on a scale |
Other Pre-specified
Satisfaction With Pain Management
Subject satisfaction with pain management as measured on a scale ranging from 1) extremely dissatisfied 2) dissatisfied 3) neither satisfied nor dissatisfied 4) satisfied 5) extremely satisfied.
Time frame: 12 months
Population: Subjects who received the study intervention and completed the 12-month follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cryoneurolysis | Satisfaction With Pain Management | Dissatisfied | 0 participants |
| Cryoneurolysis | Satisfaction With Pain Management | Neither satisfied nor dissatisfied | 1 participants |
| Cryoneurolysis | Satisfaction With Pain Management | Satisfied | 10 participants |
| Radiofrequency Ablation | Satisfaction With Pain Management | Dissatisfied | 0 participants |
| Radiofrequency Ablation | Satisfaction With Pain Management | Neither satisfied nor dissatisfied | 4 participants |
| Radiofrequency Ablation | Satisfaction With Pain Management | Satisfied | 8 participants |