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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cooled Radiofrequency | Experimental | Cooled radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain |
|
| Conventional Radiofrequency | Active Comparator | Conventional radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cooled Radiofrequency | Device | Delivery of energy to ablate sensory nerves via cooled radiofrequency probe |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Proportion of subjects experiencing adverse events through 6-months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Proportion of subjects experiencing adverse events through 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Provenzano | Pain Diagnostics and Interventional Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Spine & Pain Performance Center | Washington D.C. | District of Columbia | 20006 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41825940 | Derived | Provenzano DA, Li S, Deer TA, Kapural L, Khalouf FK, Vetri F, Zora KM, Guirguis MN, McCormick ZL. Prospective, non-inferiority, multicenter, randomized, single-blind clinical trial comparing cooled radiofrequency ablation to standard radiofrequency ablation to manage chronic facetogenic lumbar back pain. Reg Anesth Pain Med. 2026 Mar 13:rapm-2025-107299. doi: 10.1136/rapm-2025-107299. Online ahead of print. |
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The study is a participant-blinded trial and deliberate action, utilizing a physical barrier, will be taken to ensure the blind remains intact.
| Conventional Radiofrequency | Device | Delivery of energy to ablate sensory nerves via standard or conventional radiofrequency probe |
|
|
| 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 |
| 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. | 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. | 6 months |
| The proportion of subjects requiring additional intervention for their back pain during the 6-month period | 6 months |
| 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 | 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 | 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. | 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. | 12 months |
| The proportion of subjects requiring additional intervention for their back pain during the 12-month period | 12 months |
| Millennium Pain Center |
| Bloomington |
| Illinois |
| 61704 |
| United States |
| Ochsner Baptist Medical Center | New Orleans | Louisiana | 70115 | United States |
| Premier Pain Centers | Shrewsbury | New Jersey | 07702 | United States |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| University Orthopedics Center | Altoona | Pennsylvania | 16602 | United States |
| Pain Diagnostics and Interventional Care | Sewickley | Pennsylvania | 15143 | United States |
| University Orthopedics Center | State College | Pennsylvania | 16801 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| The Spine and Nerve Centers of St. Francis Hosptial | Charleston | West Virginia | 25301 | United States |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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