Cooled radiofrequency ablation of genicular nerves provides 24-Month durability in the management of osteoarthritic knee pain: Outcomes from a prospective, multicenter, randomized trial.

OBJECTIVE: To assess long-term outcomes of cooled radiofrequency ablation (CRFA) of genicular nerves for chronic knee pain due to osteoarthritis (OA). METHODS: A prospective, observational extension of a randomized, controlled trial was conducted on adults randomized to CRFA. Subjects were part of a 12-month clinical trial comparing CRFA of genicular nerves to a single hyaluronic injection for treatment of chronic OA knee pain, who then agreed to visits at 18- and 24-months post CRFA and had not undergone another knee procedure since. The subjects were evaluated for pain using the Numeric Rating Scale (NRS) function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), subjective benefit using the Global Perceived Effect (GPE) scale, quality of life using the EuroQol-5-Dimensions-5 Level (EQ-5D-5L) questionnaire, and safety. RESULTS: Of 57 subjects eligible, 36 enrolled; 32 completed the 18-month visit with a mean NRS score of 2.4 and 22 (69%) reporting ≥50% reduction in pain from baseline (primary endpoint); 27 completed the 24-month visit, with a mean NRS of 3.4 and 17 (63%) reporting ≥50% pain relief. Functional and quality of life improvements persisted similarly, with mean changes from baseline of 53.5% and 34.9% in WOMAC total scores, and 24.8% and 10.7% in EQ-5D-5L Index scores, at 18- and 24-months, respectively. There were no identified safety concerns in this patient cohort. CONCLUSION: In this subset of subjects, CRFA of genicular nerves provided durable pain relief, improved function, and improved quality of life extending to 24 months post procedure, with no significant safety concerns.

Cooled radiofrequency ablation provides extended clinical utility in the management of knee osteoarthritis: 12-month results from a prospective, multi-center, randomized, cross-over trial comparing cooled radiofrequency ablation to a single hyaluronic acid injection.

BACKGROUND: Safe and effective non-surgical treatments are an important part of the knee osteoarthritis (OA) treatment algorithm. Cooled radiofrequency ablation (CRFA) and hyaluronic acid (HA) injections are two commonly used modalities to manage symptoms associated with knee OA. METHODS: A prospective 1:1 randomized study was conducted in 177 patients comparing CRFA to HA injection with follow-ups at 1, 3, 6 and 12 months. HA subjects with unsatisfactory outcomes at 6-months were allowed to crossover and receive CRFA. Knee pain (numeric rating scale = NRS), WOMAC Index (pain, stiffness and physical function), overall quality of life (global perceived effect = GPE, EQ-5D-5 L), and adverse events were measured. RESULTS: At 12-months, 65.2% of subjects in the CRFA cohort reported ≥50% pain relief from baseline. Mean NRS pain score was 2.8 ± 2.4 at 12 months (baseline 6.9 ± 0.8). Subjects in the CRFA cohort saw a 46.2% improvement in total WOMAC score at the 12-month timepoint. 64.5% of subjects in the crossover cohort reported ≥50% pain relief from baseline, with a mean NRS pain score of 3.0 ± 2.4 at 12 months (baseline 7.0 ± 1.0). After receiving CRFA, subjects in the crossover cohort had a 27.5% improvement in total WOMAC score. All subjects receiving CRFA reported significant improvement in quality of life. There were no serious adverse events related to either procedure and overall adverse event profiles were similar. CONCLUSION: A majority of subjects treated with CRFA demonstrated sustained knee pain relief for at least 12-months. Additionally, CRFA provided significant pain relief for HA subjects who crossed over 6 months after treatment. TRIAL REGISTRATION: This trial was registered on ClinicalTrials.gov, NCT03381248. Registered 27 December 2017.

Outcomes of a Multicenter, Prospective, Crossover, Randomized Controlled Trial Evaluating Subperception Spinal Cord Stimulation at ≤1.2 kHz in Previously Implanted Subjects.

OBJECTIVE: The WHISPER randomized controlled trial (RCT) evaluates safety and clinical effectiveness of subperception spinal cord stimulation (SCS) at ≤1.2 kHz in subjects previously implanted with an SCS system for treatment of chronic, neuropathic pain. METHODS: WHISPER is a prospective, multicenter RCT with a crossover design sponsored by Boston Scientific, Marlborough, MA (ClinicalTrials.gov: NCT02314000). Eligible subjects were randomized (N = 140) to receive subperception or supraperception for three months and then crossed over to receive the alternative. Upon completion of crossover period, subjects who preferred subperception were followed up to one year. Overall pain, quality-of-life, and other outcomes were collected in the study. The primary endpoint was the overall pain responder rate (≥50% improvement from baseline) with no increase in medications. Secondary endpoints consisted of pain scores, physical disability, quality of life, and treatment preference. RESULTS: The study met its primary endpoint and demonstrated noninferiority between supraperception and subperception in a prespecified cohort of 70 randomized subjects (Interim Analysis). Thirty-nine percent of subjects with subperception settings and 29% with supraperception settings had a greater than or equal to 50% reduction in their overall pain scores with no increase in average daily medication at three-months post-activation as compared with baseline. Further assessment of all participating study subjects (N = 140) revealed similar results. Subjects were previously implanted 3.8 ± 2 years and had a disability score (Oswestry Disability Index) of 70.2 ± 11.4 at study start. Of the randomized subjects that completed the End of Period 2 Visit, 93 (66%) preferred subperception SCS and their mean overall pain reduced from 7.3 ± 1.1 (N = 89) at baseline to 4.0 ± 2.1 (N = 80) at 12-months post-activation. Post hoc analysis also demonstrated that multiple options provide superior outcomes, as supported by a 74% increase in the responder rate when subjects could choose their most effective option (47%) compared with supraperception alone (27%). DISCUSSION: Subperception SCS at ≤1.2 kHz is safe and effective in subjects with extreme physical disability and previously implanted for chronic pain. Further, by providing study participants with different waveform options, increased pain relief was achieved.

Cooled Radiofrequency Ablation Treatment of the Genicular Nerves in the Treatment of Osteoarthritic Knee Pain: 18- and 24-Month Results.

OBJECTIVE: The primary objective of this observational, prospective, multicenter study was to evaluate the long-term outcomes, including pain, function, and perceived effect of treatment, in subjects undergoing cooled radiofrequency ablation (CRFA) who have pain due to osteoarthritis (OA) of the knee. METHODS: This analysis included a subset of subjects previously enrolled in a prospective, multicenter randomized study comparing the safety and effectiveness of CRFA and intra-articular steroid injection in patients with knee OA through 12 months who were contacted to participate in this extension study. Subjects were enrolled if they agreed to participate in up to 2 additional follow-ups, at 18 and 24 months. RESULTS: Eighty-three subjects from the 5 participating sites underwent CRFA during the original study and were contacted for this extension study. Of the 33 subjects enrolled, 25 were evaluated at 18 months after CRFA treatment, and their mean numeric rating scale (NRS) score was 3.1 ± 2.7, with 12 subjects reporting ≥50% pain relief compared to baseline. At 24 months, 18 subjects reported a mean NRS score of 3.6 ± 2.8, with 11 demonstrating ≥50% pain relief. Functional improvement as measured by the Oxford Knee Score continued to be present, with an overall mean change from baseline of 26.0 ± 9.6 points at 18 months and 29.9 ± 10.4 points at 24 months. CONCLUSION: In this subset of subjects from a randomized controlled trial, CRFA provided sustained pain relief, improved function, and perceived positive effect through 24 months for subjects with OA knee pain with no safety concerns identified.

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain.

Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. Clinical Trial Registration: NCT01719055 (ClinicalTrials.gov).

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.

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.

Twelve-month analgesia and rescue, by cooled radiofrequency ablation treatment of osteoarthritic knee pain: results from a prospective, multicenter, randomized, cross-over trial.

BACKGROUND AND OBJECTIVES: As a follow-up to the 6-month report,12 this study investigated the analgesic effect of cooled radiofrequency ablation (CRFA) in patients with knee osteoarthritis (OA) 12 months postintervention and its ability to provide pain relief in patients who experienced unsatisfactory effects of intra-articular steroid injection (IAS). METHODS: Seventy-eight per cent (52/67) of patients originally treated with CRFA were evaluated at 12 months, while at 6 months post-IAS, 82% (58/71) of those patients crossed over to CRFA and assessed 6 months later. RESULTS: At 12 months, 65% of the original CRFA group had pain reduction ≥50%, and the mean overall drop was 4.3 points (p<0.0001) on the numeric rating scale. Seventy-five per cent reported 'improved' effects. The cross-over group demonstrated improvements in pain and functional capacity (p<0.0001). No unanticipated adverse events occurred. CONCLUSIONS: This study demonstrates that analgesia following CRFA for OA knee pain could last for at least 12 months and could rescue patients who continue to experience intolerable discomfort following IAS. CLINICAL TRIAL REGISTRATION: The ClinicalTrials.gov registration number for this study is NCT02343003.

Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis.

BACKGROUND AND OBJECTIVES: Osteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain. METHODS: This is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention. RESULTS: There were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRS: pain reduction 50% or greater: 74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events. CONCLUSIONS: This study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT02343003).