Last reviewed · How we verify
Cooled Radiofrequency vs. Hyaluronic Acid to Manage Knee Pain
NA trial testing Cooled Radiofrequency in Osteoarthritis of the Knee in 177 participants. Completed in 20 July 2020.
| Lead sponsor | Avanos Medical |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 177 |
| Start date | 7 December 2017 |
| Primary completion | 8 February 2019 |
| Estimated completion | 20 July 2020 |
| Sites | 10 locations across United States |
Avanos Medical
21 and older, any sex, with Osteoarthritis of the Knee. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The proportion of subjects whose knee pain is reduced by ≥ 50% based on the NRS. The NRS is an 11-point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals the "worst pain". There are no sub-scales.
| Group | Value | 95% CI |
|---|---|---|
| Cooled Radiofrequency | 54 | |
| Hyaluronic Acid Injection, Then Cooled Radiofrequency Crossover Option | 31 |
Safety: The proportion of subjects experiencing adverse events through final follow up.
| Group | Value | 95% CI |
|---|---|---|
| Cooled Radiofrequency | 78 | |
| Hyaluronic Acid Injection | 48 | |
| Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency | 38 |
The proportion of subjects whose knee pain is reduced from baseline by ≥ 50% based on the NRS. The NRS is an 11-point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals the "worst pain". There are no sub-scales.
| Group | Value | 95% CI |
|---|---|---|
| Cooled Radiofrequency | 43 | |
| Hyaluronic Acid Injection | 10 | |
| CROSSOVER From Hyaluronic Acid Injection to Cooled Radiofrequency | 40 |
The change in WOMAC score from baseline to 6 months. This outcome instrument is composed of three sub-scales, including "Pain" (5 questions), "Stiffness" (2 questions), and "Physical Function" (17 questions). The point range for each sub-scale question is from 0 to 4, with "0" indicating the best study subject condition and "4" indicating the worst study subject condition. Thus, the minimum score per sub-scale is 0, and the maximum is 20, 8, and 68 for "Pain", Stiffness", and "Physical Function", respectively. The minimum and maximum possible scores for the entire instrument are 0 (best study
| Group | Value | 95% CI |
|---|---|---|
| Cooled Radiofrequency | 31.5 | ± 23.0 |
| Hyaluronic Acid Injection | 14.8 | ± 19.4 |
The change in WOMAC score from baseline to 12 months. This outcome instrument is composed of three sub-scales, including "Pain" (5 questions), "Stiffness" (2 questions), and "Physical Function" (17 questions). The point range for each sub-scale question is from 0 to 4, with "0" indicating the best study subject condition and "4" indicating the worst study subject condition. Thus, the minimum score per sub-scale is 0, and the maximum is 20, 8, and 68 for "Pain", Stiffness", and "Physical Function", respectively. The minimum and maximum possible scores for the entire instrument are 0 (best study
| Group | Value | 95% CI |
|---|---|---|
| Cooled Radiofrequency | 30.7 | ± 25.2 |
| Hyaluronic Acid Injection | 32.1 | ± 18.3 |
| Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency | 18.1 | ± 22.1 |
The change in measured EQ-5D-5L scale from baseline to 6 months. This outcome instrument is composed 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
| Group | Value | 95% CI |
|---|---|---|
| Cooled Radiofrequency | 0.12 | ± 0.14 |
| Hyaluronic Acid Injection | 0.06 | ± 0.15 |
The change in measured EQ-5D-5L scale from baseline to 12 months. This outcome instrument is composed 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 Anxiet
| Group | Value | 95% CI |
|---|---|---|
| Cooled Radiofrequency | 0.12 | ± 0.14 |
| Hyaluronic Acid Injection | 0.14 | ± 0.14 |
| Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency | 0.08 | ± 0.15 |
Number of participants with improvement measured by the Global Perceived Effect scale. 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. Number of participants scoring at either 5, 6, or 7 points on the Global Perceived Effect scale are reported.
| Group | Value | 95% CI |
|---|---|---|
| Cooled Radiofrequency | 55 | |
| Hyaluronic Acid Injection | 33 |
Number of participants with improvement measured by the Global Perceived Effect scale. 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. Number of participants scoring at either 5, 6, or 7 points on the Global Perceived Effect scale are reported.
| Group | Value | 95% CI |
|---|---|---|
| Cooled Radiofrequency | 42 | |
| Hyaluronic Acid Injection | 8 | |
| Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency | 39 |
The proportion of subjects whose knee pain is reduced from baseline by ≥ 50% based on the NRS. The NRS is an 11-point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals the "worst pain". There are no sub-scales.
| Group | Value | 95% CI |
|---|---|---|
| Cooled Radiofrequency | 22 |
The proportion of subjects whose knee pain is reduced from baseline by ≥ 50% based on the NRS. The NRS is an 11-point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals the "worst pain". There are no sub-scales.
| Group | Value | 95% CI |
|---|---|---|
| Cooled Radiofrequency | 17 |
The change in WOMAC score from baseline to 18 months. This outcome instrument is composed of three sub-scales, including "Pain" (5 questions), "Stiffness" (2 questions), and "Physical Function" (17 questions). The point range for each sub-scale question is from 0 to 4, with "0" indicating the best study subject condition and "4" indicating the worst study subject condition. Thus, the minimum score per sub-scale is 0, and the maximum is 20, 8, and 68 for "Pain", Stiffness", and "Physical Function", respectively. The minimum and maximum possible scores for the entire instrument are 0 (best study
| Group | Value | 95% CI |
|---|---|---|
| Cooled Radiofrequency | 29.3 | ± 25.3 |
Time frame: Total Study: Baseline to 24 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cooled Radiofrequency | Hyaluronic Acid Injection | Crossover From Hyaluronic … |
|---|---|---|---|---|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | — | — | — |
| Cardiovascular | Cardiac disorders | — | — | — |
| Gastrointestinal | Gastrointestinal disorders | — | — | — |
| H.E.E.N.T | General disorders | — | — | — |
| Neurological | Nervous system disorders | — | — | — |
| Genitourinary | Renal and urinary disorders | — | — | — |
| Other | General disorders | — | — | — |
| Blood/Lymphatic | Blood and lymphatic system disorders | — | — | — |
| Endocrine/Metabolic | Endocrine disorders | — | — | — |
| Extremities | Musculoskeletal and connective tissue disorders | — | — | — |
| Respiratory | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Skin | Skin and subcutaneous tissue disorders | — | — | — |
| Reaction | System | Cooled Radiofrequency | Hyaluronic Acid Injection | Crossover From Hyaluronic … |
|---|---|---|---|---|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | — | — | — |
| Other | General disorders | — | — | — |
| Neurological | Nervous system disorders | — | — | — |
| Cardiovascular | Cardiac disorders | — | — | — |
| Endocrine/Metabolic | Endocrine disorders | — | — | — |
| Skin | Skin and subcutaneous tissue disorders | — | — | — |
| Blood/Lymphatic/Infection | Blood and lymphatic system disorders | — | — | — |
| Gastrointestinal | Gastrointestinal disorders | — | — | — |
| Genitourinary | Renal and urinary disorders | — | — | — |
| Respiratory | Respiratory, thoracic and mediastinal disorders | — | — | — |
| H.E.E.N.T / Infection | Ear and labyrinth disorders | — | — | — |
Most-reported serious reactions: Musculoskeletal, Cardiovascular, Gastrointestinal, H.E.E.N.T, Neurological, Genitourinary, Other, Blood/Lymphatic.
Data from ClinicalTrials.gov NCT03381248 adverse events section.
This is a prospective, randomized, multicenter comparison study examining the outcomes of subjects with osteoarthritis and knee pain undergoing a procedure to create a radiofrequency lesion of the genicular nerves with the Cooled Radiofrequency Ablation (CRFA) system compared to subjects receiving Hyaluronic Acid (HA). Approximately 168 subjects will be enrolled into this study, with subjects undergoing either CRFA or HA injection in a 1:1 randomization scheme. Follow-up will be conducted for 12 months post-CRFA, with the primary endpoint being completed at month 6. Subjects randomized to the comparison (HA) group will have the option to cross-over to the neurotomy group after completing the 6-month endpoint assessment. They will be followed for an additional 6 months. Pain, overall outcome, quality of life, pain medication use, and adverse events will be compared between the two treatment groups to determine success. Subjects who were randomized to and received COOLIEF\* as their initial treatment will have the option to add 2 additional visits at 6-month intervals, representing 18 and 24 months post initial treatment.
5 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03381248.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing