Low Back Pain Clinical Trial
Official title:
A Single-center, Randomized, Pilot Study to Assess Iovera° Lumbar Medial Branch Cryoneurolysis vs Lumbar Radiofrequency Ablation for Facet Mediated Chronic Low Back Pain
NCT number | NCT06016127 |
Other study ID # | CRS-107 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 18, 2022 |
Est. completion date | October 23, 2023 |
Verified date | January 2024 |
Source | Medical Pain Management Services, PLLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 23, 2023 |
Est. primary completion date | October 23, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | The Albany & Saratoga Centers For Pain Management | Saratoga Springs | New York |
Lead Sponsor | Collaborator |
---|---|
Medical Pain Management Services, PLLC | Pacira Pharmaceuticals, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in functional disability | Function disability will be measured by the Oswestry Disability Index. The score ranges from 0-50, with lower scores reflecting milder disability. | 0-12 months | |
Other | Change in Patients' Global Impression of Change | The Patients' Global Impression of Change (PGIC) is a 7-point patient self-reporting scale of overall change in activity limitations, symptoms, emotions, and quality of life ranging from 1) no change 2) hardly any change 3) no noticeable change 4) change has not made any real difference 5) a slight but noticeable change 6) a definite improvement 7) considerable improvement.
The scale also assesses degree of change since beginning care (0=much better, 10=much worse). |
0-12 months | |
Other | 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. | 0-12 months | |
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. | 0-12 months | |
Secondary | Change in pain intensity as measured by 11-point Numeric Rating Scale (NRs) | 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 worst and average level of pain over the past 24 hours. |
0-12 months |
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