Summary of prospective studies on the effectiveness of the cooled radiofrequency treatment in patients with chronic knee pain
| Author, year | Study design | Patient | Groups | Outcome measures | Results | Complications | Comments |
|---|---|---|---|---|---|---|---|
| McCormick et al., 2017 [51] | Cross-sectional study | Knee OA and 50% or greater pain relief following GN blocks | CRFA (n = 33, 52 discrete knees) | NRS, MQSIII, and PGIC |
35% resulted in a 50% or greater reduction in NRS scores, reductions of 3.4 or more points in MQSIII scores, and "very much improved/improved" PGIC scores. 19% resulted in complete pain relief at a minimum of six months of follow-up. |
No serious adverse events | |
| Davis et al., 2018 [15] | Multicenter, cross-over, RCT | Chronic knee pain (OA) |
CRFA (n = 76) IAS (n = 75) |
NRS, OKS, GPE, and analgesic drug use at 1, 3, and 6 mo | The CRFA group had more favorable outcomes in NRS at 6 mo: pain reduction, 50% or greater (74.1% vs. 16.2%); mean NRS score reduction, 4.9 ± 2.4 vs. 1.3 ± 2.2; mean OKS, 35.7 ± 8.8 vs. 22.4 ± 8.5; mean improved GPE, 91.4% vs. 23.9%; mean changes in nonopioid medication use, CRFA > IAS. | No serious adverse events | |
| Davis et al., 2019 [55] | Multicenter, cross-over, RCT | Chronic knee pain (OA) |
CRFA (n = 58) IAS (n = 4) XO (IAS → CRFA, n = 58) |
NRS, OKS, GPE, and analgesic drug use at 12 mo | At 12 mo, 65% of the original CRFA group had pain reduction ≥ 50%, and the mean overall drop was 4.3 points on NRS. In addition, 75% reported' improved' effects. The cross-over group demonstrated improvements in pain and functional capacity. | No serious adverse events related to CRFA | The XO group was a group that performed CRFA in the IAS group in the previous study. |
| Walega et al., 2019 [54] | Randomized sham-controlled trial | Postoperative pain after TKA |
CRFA (n = 35) Sham (n = 32) |
Opioid consumption, MQSIII, WOMAC, HADS, SF-12, and McGill Pain Questionnaire score | No difference in opioid consumption, postoperative analgesia side effects, and MQSIII for 48 hr, no difference in physical functioning for 2 d, and no difference in any outcome measure at 1, 3, or 6 mo. | No adverse events | Cooled RFA of the superior lateral, superior medial, and inferomedial genicular nerves when performed 2–6 wk prior to elective TKA |
| Chen et al., 2020 [56] | Multicenter RCT | Chronic knee pain (OA) |
CRFA (n = 88) HA (n = 87) |
NRS, WOMAC, GPE, EQ-5D-5L, and safety at 1, 3, and 6 mo | Successful responders (≥ 50% reduction in NRS) (CRFA vs. HA): 71% vs. 38%. Mean NRS reduction at 6 mo: 4.1 ± 2.2 vs. 2.5 ± 2.5. Mean WOMAC improvement at 6 mo: 48.2 vs. 22.6. GPE improvement at 6 mo: 72% vs. 40%. | CRFA vs. HA: 19% vs. 14% | |
| Vallejo et al., 2023 [62] | Double-blind RCT | Chronic knee pain (OA) |
CRFA (n = 49) MRFA (n = 47) |
VAS, WOMAC, OKS, 5-point Likert scale, and adverse events during 52 wk (1, 4, 12, 24, 52) | Effective for 52 wk in both groups. CRFA seemed to be better sustained beyond 24 wk than MRFA (no significant difference at any time point). | Moderate worsening of knee pain 1 in the CRFA group and 2 in the MRFA group | |
| Vanneste et al., 2023 [63] | Multicenter double-blind, noninferiority, and pilot RCT | Knee OA, PPSP after TKA |
RFA (n = 24) CRFA (n = 25) |
Responder at 3 mo, knee pain, functionality, QOL, emotional health, and adverse effect at 6 mo |
Successful responders: 17% vs. 33% (no significant difference). Inconclusive for noninferiority. |
Subcutaneous hematoma (3), infrapatellar hypoesthesia (1), and transient increase in pain (2) in the CRFA group. Transient increase in pain (5) in the RFA group. |
Insufficient sample size (pilot trial) Low statistical power |
CRFA: cooled radiofrequency ablation, EQ-5D-5L: EuroQol-5 Dimensions-5 Level, GN: genicular nerve, GPE: Global Perceived Effect, HA: hyaluronic acid, HADS: Hospital Anxiety and Depression Inventory scores, IAS: intra-articular steroid, MRFA: monopolar radiofrequency ablation, MQSIII: medication quantification scale III, NRS: numeric rating scale, OA: osteoarthritis, OKS: Oxford Knee Score, PGIC: patient global impression of change, PPSP: persistent postsurgical pain, QOL: quality of life, RCT: randomized clinical trial, RFA: radiofrequency ablation, SF-12: 12-Item Short Form Health Survey, TKA: total knee arthroplasty, VAS: visual analog scale, WOMAC: Western Ontario McMaster Universities Osteoarthritis index.