Low Back Pain, Chronic
Conditions
Keywords
Iovera, Radiofrequency ablation, cryoneurolysis, low back pain, lumbar medial branch
Brief summary
A research study is being conducted to compare two treatments for long-term low back pain: * One uses the iovera° system, which applies cold to certain nerves in the lower back. * The other is the standard treatment called radiofrequency ablation, which uses heat. The primary objective is to find out which treatment works better to reduce back pain. Participants in this study will be randomly placed in one of the two treatment groups. The clinical research team will check on participant pain levels and overall health before and after the procedure for about 12 months. The entire study will last about 14 months for each participant.
Detailed description
Secondary objectives of this study include: 1. Evaluate safety outcomes (i.e., adverse device effects, serious adverse device effects, and adverse events) related to iovera° treatment; 2. Evaluate clinical outcomes related to iovera° treatment including pain, functional disability, and concomitant medication use (including opioids and analgesics); 3. Evaluate the treatment success and failure rate of iovera° medial branch cryoneurolysis; 4. Evaluate health-related quality of life (HRQoL); 5. Evaluate subject satisfaction with pain management; 6. Identify subgroups of patients who are most and least likely to benefit from iovera° medial branch cryoneurolysis for facet-mediated CLBP. An adaptive study design will be used in this study. A blinded interim analysis will occur after approximately 56 total subjects, at least 28 per study arm, have completed assessment data for the primary efficacy outcome. The primary purpose of this interim analysis is to evaluate the sample size assumptions.
Interventions
DEVICEIovera Medial Branch Cryoneurolysis
The iovera group will receive fluoroscopic guided medial branch cryoneurolysis with the subject in the prone position under asepsis: * Investigator injects 1% lidocaine at the treatment site using a 25-gauge, 3/4 -inch needle to numb the skin and tissue around the facet joint * Introducer needle is inserted through the skin wheal to the target medial branch nerve below the junction of the superior articular and transverse process * The introducer needle is positioned, and an x-ray image is taken to confirm the needle's position * With the desired introducer needle position confirmed, the iovera Smart Tip is guided through the introducer needle and the handpiece is secured to the Smart Tip. The start/stop button on the iovera° handpiece is then pressed to start the cycle. * After the cycle is complete, Smart Tip can be removed and next treatment cycle can commence ensuring an overlap of the ice ball * The needle is removed, and light compression is applied with gauze
PROCEDURERadiofrequency ablation (RFA)
Subjects will receive a fluoroscopic guided RFA medial branch block in the prone position under asepsis: * The Right L4, L5, S1 articular pillars are identified with fluoroscopy at each level and the target points are located * A skin wheal is formed using 5mL 1% Lidocaine and 5mL 0.25% Bupivacaine * A 20-gauge, 10cm needle with a 10mm active tip is inserted using a 15-degree oblique view and a 15-degree caudad angle onto the waist of each pillar at each level * Anterior-posterior and oblique neuroforamen views confirm positioning * Stimulation is performed and recorded to confirm proper needle placement * A mixture of 3mL of 0.25% Bupivacaine and 2mL of 1% Lidocaine is divided and injected at each level * A lesion is then performed at each level at 80 degrees centigrade for 60 seconds * The needles are removed, and bandages applied to the puncture sites * The same procedure is carried out on the opposite side
Sponsors
Montefiore Medical Center
Pacira Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
1:1 randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following inclusion criteria to be eligible for participation: * Subjects at least 18 years of age at Screening * Primary complaint of axial low-back pain suggestive of bilateral facet joint involvement (i.e., facet mediated CLBP) by evidence of provocative testing (e.g., axial loading, paraspinal tenderness) * Low back pain is chronic (i.e., ≥ 3 months' duration) * Low back pain is moderate to severe (score of ≥ 5 to ≤ 9) on the 0 to 10 NRS at Screening * Low back pain causes functional impairment (≥ 30% on ODI) at Screening * 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 80% relief of primary (index) pain for the duration of the local anesthetic used * Failure of at least three months of conservative non-operative therapy (e.g., physical therapy, chiropractic care, sleep hygiene, weight loss, spinal injections, NSAIDs, physician-directed exercise program or other appropriate analgesics) * Able to provide informed consent, adhere to the study visit schedule, and complete all study assessment
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric rating scale (NRS) pain intensity score | 360 days after intervention | Subjects will evaluate their pain in the low back region using an 11-point NRS where 0=no pain and 10=worst possible pain, such that higher scores are associated with greater pain intensity. * Pain intensity scores (using the NRS) measured as "On a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, how much pain are you experiencing in your low back right now? * Pain intensity scores (using the numeric rating scale; NRS) measured as "On a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, what was the worst pain in your low back in the last 24 hours?" * Pain intensity scores (using the NRS) measured as "On a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, what was the average pain in your low back in the last 24 hours?" Mean numeric pain intensity rating scores will be summarized by study arm using basic descriptive statistics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Disability from baseline using Oswestry Disability Questionnaire | 360 days after intervention | The Oswestry Disability Questionnaire is a 10-item condition-specific measure of functional status (pain and disability) for patients with low back pain (LBP). Each question has 6 possible answers (0 = worse, 5 = best). The raw score is doubled to provide a percent score from 0 to 100%; with 0 equaling no disability and 100% equaling the worst possible outcome. It measures pain-related disability. Change from baseline scores will be summarized by study arm using descriptive statistics. |
| Change in Patients' Global Impression of Change (PGIC) scale from baseline | 360 days after intervention | The Patient Global Impression of Change (PGIC) scale is a subjective measure used to evaluate a patient's perceived improvement following treatment, rated on a 7-point Likert scale ranging from 1 to 7 \[1= "No change (or condition has got worse)" to 7 = "a great deal better, and a considerable improvement that has made all the difference"\], wherein higher scores are associated with improved patient impression following treatment. Change from baseline scores will be summarized by study arm using descriptive statistics. |
Countries
United States
Contacts
CONTACTKarina Gritsenko, MD
CONTACTRafi Khandaker, BA
PRINCIPAL_INVESTIGATORKarina Gritsenko, MD
Montefiore Medical Center
Outcome results
None listed