This is a single-center, randomized, open-label, pilot study in adult subjects with chronic sacroiliac joint (SIJ) pain. Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive ioveraº cryoneurolysis or radiofrequency ablation.
This is a single-center, randomized, pilot study in adult subjects with chronic SIJ pain. Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive ioveraº cryoneurolysis or radiofrequency ablation (RFA). This study is designed to evaluate the clinical effectiveness of iovera° cryoneurolysis in adult subjects with chronic SIJ pain. 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 an efficacy randomized controlled trial (RCT). Randomization to treatment groups according to the randomization assignment will be performed on the day of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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 "STT21180STIM" Smart Tip will be used in this study.
Radiofrequency ablation is a minimally invasive procedure that uses heat at the lumbosacral spine to destroy the target spinal nerves.
Safety and Clinical Effectiveness 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
Pain Intensity
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: 0-12 Months
Functional disability
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
Concomitant medication use
Concomitant medication use will be collected per participant medication diary.
Time frame: 0-12 months
Success and failure rate of study interventions
Treatment success or failure will be determined at Day 180 (± 5 days) as described by Birkenmaier et al.: 1. Full success of treatment is when pain is reduced to 50% or less of pre-treatment levels 2. Partial success of treatment is when pain is reduced between 51-69% of pre-treatment levels 3. Failure of treatment is when pain is reduced to 70% or greater of pre-treatment levels
Time frame: Day 180
Shor-form 12 (SF-12)
Health-related quality of life will be measured by the short-form (SF) 12. The SF-12 is a self administered 12-item questionnaire that assesses an individual's physical and mental health status across eight domains. Total scores range form 0-100 with scores above 50 indicating better-than-average health-related quality of life, and scores below 50 indicating below-average health.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Screening, Day 90 (± 5 days), Day 180 (± 5 days), Day 270 (± 7 days), Day 360 (± 7 days)
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
Patients' Global Impression of Change
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