An interventional study of Cooled Radiofrequency and Conventional Radiofrequency in Chronic Low-back Pain, sponsored by Avanos Medical. Status unknown at 10 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2022-06-30.
Sponsored by Avanos Medical · Not applicable, Interventional, and Treatment
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 79 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Avanos Medical is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Cooled radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain
Device: Cooled Radiofrequency
Conventional radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain
Device: Conventional Radiofrequency
Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Also known as: Coolief
Delivery of energy to ablate sensory nerves via standard or conventional radiofrequency probe
Also known as: Standard Radiofrequency
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.
Time frame: 6 months
The proportion of subjects requiring additional intervention for their back pain during the 6-month period
Time frame: 6 months
The proportion of subjects whose back pain is reduced by ≥ 50 percent based on the NRS scale at 12 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: 12 months
Proportion of subjects experiencing adverse events through 12 months
Time frame: 12 months
The mean change in SF-36 Physical Functioning (PF) score from baseline to the 12-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: 12 months
The mean change in Oswestry Disability Index (ODI) score from baseline to the 12-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: 12 months
The measured Global Perceived Effect scale at the 12-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: 12 months
The mean change in EQ-5D-5L score from baseline to the 12-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.
Time frame: 12 months
The proportion of subjects requiring additional intervention for their back pain during the 12-month period
Time frame: 12 months
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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