Cooled Radiofrequency Ablation Compared with a Single Injection of Hyaluronic Acid for Chronic Knee Pain: A Multicenter, Randomized Clinical Trial Demonstrating Greater Efficacy and Equivalent Safety for Cooled Radiofrequency Ablation.

Abstract

BACKGROUND:

Knee osteoarthritis is a painful and sometimes debilitating disease that often affects patients for years. Current treatments include short-lasting and often repetitive nonsurgical options, followed by surgical intervention for appropriate candidates. Cooled radiofrequency ablation (CRFA) is a minimally invasive procedure for the treatment of pain related to knee osteoarthritis. This trial compared the efficacy and safety of CRFA with those of a single hyaluronic acid (HA) injection.

METHODS:

Two hundred and sixty subjects with knee osteoarthritis pain that was inadequately responsive to prior nonoperative modalities were screened for enrollment in this multicenter, randomized trial. One hundred and eighty-two subjects who met the inclusion criteria underwent diagnostic block injections and those with a minimum of 50% pain relief were randomized to receive either CRFA on 4 genicular nerves or a single HA injection. One hundred and seventy-five subjects were treated (88 with CRFA and 87 with HA). Evaluations for pain (Numeric Rating Scale [NRS]), function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]), quality of life (Global Perceived Effect [GPE] score and EuroQol-5 Dimensions-5 Level [EQ-5D-5L] questionnaire), and safety were performed at 1, 3, and 6 months after treatment.

RESULTS:

Demographic characteristics did not differ significantly between the 2 study groups. A total of 158 subjects (76 in the CRFA group and 82 in the HA group) completed the 6-month post-treatment follow-up. In the CRFA group, 71% of the subjects had ≥50% reduction in the NRS pain score (primary end point) compared with 38% in the HA group (p < 0.0001). At 6 months, the mean NRS score reduction was 4.1 ± 2.2 for the CRFA group compared with 2.5 ± 2.5 for the HA group (p < 0.0001). The mean WOMAC score improvement at 6 months from baseline was 48.2% in the CRFA group and 22.6% in the HA group (p < 0.0001). At 6 months, 72% of the subjects in the CRFA group reported improvement in the GPE score compared with 40% in the HA group (p < 0.0001).

CONCLUSIONS:

CRFA-treated subjects demonstrated a significant improvement in pain relief and overall function compared with subjects treated with a single injection of HA. No serious adverse events related to either procedure were noted, and the overall adverse-event profiles were similar.

LEVEL OF EVIDENCE:

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

• Authors: Antonia F Chen, Fred Khalouf, Keith Zora, Michael DePalma, Lynn Kohan, Maged Guirguis, Douglas Beall, Eric Loudermilk, Matthew Pingree, Ignacio Badiola, Jeffrey Lyman
• Journal: The Journal of bone and joint surgery. American volume (J Bone Joint Surg Am) Vol. 102 Issue 17 Pg. 1501-1510 (Sep 02 2020) ISSN: 1535-1386 [Electronic] United States
• PMID: 32898379 (Publication Type: Comparative Study, Equivalence Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Viscosupplements
• Hyaluronic Acid

Topics

• Adult
• Aged
• Aged, 80 and over
• Arthralgia (therapy)
• Chronic Pain (therapy)
• Cold Temperature
• Female
• Humans
• Hyaluronic Acid (administration & dosage)
• Injections, Intra-Articular
• Knee Joint
• Male
• Middle Aged
• Radiofrequency Ablation (methods)
• Treatment Outcome
• Viscosupplements (administration & dosage)