This study is being conducted to assess the relative effectiveness of radiofrequency neurotomy in subjects with chronic axial low back pain originating in the lumbar facet joints using the COOLIEF\* Cooled Radiofrequency Probe as compared to the same procedure conducted using a Standard Radiofrequency Probe.
This is a prospective, multi-center, randomized, single-blind comparison study examining the outcomes of subjects with chronic axial low back pain that originates in the lumbar facet joints undergoing a procedure to create a radiofrequency lesion in the medial branch nerves with either Cooled Radiofrequency Ablation (CRFA) or Conventional (Standard) Radiofrequency Ablation (SRFA). Approximately 188 participants from approximately 15 sites will be enrolled into this study, with subjects undergoing either CRFA or SRFA in a 1:1 randomization scheme. Follow-up will be conducted for 12 months post-treatment, with the primary endpoint being completed at month 6. Pain, overall outcome, quality of life, pain medication use, and adverse events will be compared between the two treatment groups to determine success.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
79
Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Delivery of energy to ablate sensory nerves via standard or conventional radiofrequency probe
International Spine & Pain Performance Center
Washington D.C., District of Columbia, United States
Millennium Pain Center
Bloomington, Illinois, United States
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States
The proportion of subjects whose back pain is reduced by ≥ 50 percent based on the NRS scale at 6 Months
The NRS is an 11-point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals "worst pain". There are no sub-scales.
Time frame: 6 months
Proportion of subjects experiencing adverse events through 6-months
Time frame: 6 months
The mean change in SF-36 Physical Functioning (PF) score from baseline to the 6-month visit
Short Form 36-PF - score range = 0 - 100. "0" corresponds to "greatest disability" and "100" indicates "no disability". The means of these scores and their respective standard deviations are reported for each study group
Time frame: 6 months
The mean change in Oswestry Disability Index (ODI) score from baseline to the 6-month visit
ODI - score range = 0 - 100. "0" corresponds to "no disability" and "100" indicates the "maximum disability possible". The means of these scores and their respective standard deviations are reported for each study group
Time frame: 6 months
The measured Global Perceived Effect scale at the 6-month visit
The Global Perceived Effect is a 7-point scale: 1 point = "worst ever", 2 points = "much worse", 3 points = "worse", 4 points = "not improved but not worse", 5 points = "improved", 6 points = "much improved", 7 points = "best ever". There are no sub-scales.
Time frame: 6 months
The mean change in EQ-5D-5L score from baseline to the 6-month visit
This outcome instrument is composed two components. The first component consists of five sub-scales containing five questions each. The point range for each sub-scale is from 1 to 5, with "1" indicating the best study subject condition and "5" indicating the worst study subject condition. Thus, the minimum and maximum scores per sub-scale are 1 and 5, respectively, and such scores for the entire instrument are 5 (best study subject condition) and 25 (worst study subject condition). The sub-scale topics are: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. The second component, EQ-Visual Analog Scale (VAS), has a score range of 0 - 100. "0" corresponds to the "worst imaginable health state" and "100" indicates the "best imaginable health state". The means of these scores and their respective standard deviations are reported for each study group.
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Premier Pain Centers
Shrewsbury, New Jersey, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
University Orthopedics Center
Altoona, Pennsylvania, United States
Pain Diagnostics and Interventional Care
Sewickley, Pennsylvania, United States
University Orthopedics Center
State College, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
The Spine and Nerve Centers of St. Francis Hosptial
Charleston, West Virginia, United States
Time frame: 6 months
The proportion of subjects requiring additional intervention for their back pain during the 6-month period
Time frame: 6 months