Dataset Information

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.

ABSTRACT: 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).

SUBMITTER: Davis T

PROVIDER: S-EPMC5768219 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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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.

Davis Tim T Loudermilk Eric E DePalma Michael M Hunter Corey C Lindley David D Patel Nilesh N Choi Daniel D Soloman Marc M Gupta Anita A Desai Mehul M Buvanendran Asokumar A Kapural Leonardo L

Regional anesthesia and pain medicine 20180101 1

<h4>Background and objectives</h4>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.<h4>Methods</h4>This is a prospective, multicenter, randomized trial with ...[more]

PMID: 29095245

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Project description:BackgroundFor patients with painful knee osteoarthritis, long-term symptomatic relief may improve quality of life. Cooled radiofrequency ablation (CRFA) has demonstrated significant improvements in pain, physical function and health-related quality of life compared with conservative therapy with intra-articular steroid (IAS) injections. This study aimed to establish the cost-effectiveness of CRFA compared with IAS for managing moderate to severe osteoarthritis-related knee pain, from the US Medicare system perspective.MethodsWe conducted a cost-effectiveness analysis utilizing efficacy data (Oxford Knee Scores) from a randomized, crossover trial on CRFA (NCT02343003), which compared CRFA with IAS out to 6 and 12 months, and with IAS patients who subsequently crossed over to receive CRFA after 6 months. Outcomes included health benefits (quality-adjusted life-years [QALYs]), costs and cost-effectiveness (expressed as cost per QALY gained). QALYs were estimated by mapping Oxford Knee Scores to the EQ-5D generic utility measure using a validated algorithm. Secondary analyses explored differences in the settings of care and procedures used in-trial versus real-world clinical practice.ResultsCRFA resulted in an incremental QALY gain of 0.091 at an incremental cost of $1711, equating to a cost of US$18,773 per QALY gained over a 6-month time horizon versus IAS. Over a 12-month time horizon, the incremental QALY gain was 0.229 at the same incremental cost, equating to a cost of US$7462 per QALY gained versus IAS. Real-world cost assumptions resulted in modest increases in the cost per QALY gained to a maximum of US$21,166 and US$8296 at 6 and 12 months, respectively. Sensitivity analyses demonstrated that findings were robust to variations in efficacy and cost parameters.ConclusionsCRFA is a highly cost-effective treatment option for patients with osteoarthritis-related knee pain, compared with the US$100,000/QALY threshold typically used in the US.

Project description:IntroductionGenicular nerve radiofrequency ablation (GNRFA) is a minimally invasive intervention for patients with chronic knee pain (CKP) not responding to conservative treatments. Few investigations have compared treatment outcomes of cooled-RFA (c-RFA) and thermal-RFA (t-RFA), two common approaches of GNRFA. This study aims to investigate and compare outcomes, including probability of treatment success, between c-RFA and t-RFA in patients with CKP.MethodsThis retrospective cohort study analyzed a total of 208 propensity score matched patients, including 104 patients who received c-RFA and 104 patients who received t-RFA. The primary outcome was probability of pain relief after the procedure, defined as reduction in Numeric Rating Scale (NRS) pain score of 2 or greater. The secondary outcomes were degree of NRS pain score reductions, duration of relief, and the probability of patients receiving TKA within 1 year of treatment.ResultsT-RFA was associated with a higher probability of pain relief within 1, 3, and 6 months after procedure when compared with c-RFA. Probabilities of pain relief from t-RFA and c-RFA were 62% (95% CI 51% to 71%) and 43% (95% CI 34% to 53%; p=0.01) within 1 month, 78% (95% CI 68% to 85%) and 55% (95% CI 45% to 64%; p<0.001) within 3 months, and 79% (95% CI 70% to 86%) and 59% (95% CI 49% to 68%; p<0.01) within 6 months, respectively. t-RFA was also associated with greater mean NRS pain score reduction at 1 month after procedure: -4.71 (95% CI -5.3 to -4.1) when compared with -3.59 (95% CI -4.3 to -2.9; p=0.02) from c-RFA. T-RFA and c-RFA were comparable in pain score reduction at 3, 6, 9 and 12 months after procedure. Both groups demonstrated comparable duration of relief and probability of patients receiving TKA within 1 year.DiscussionBoth t-RFA and c-RFA effectively reduced NRS pain scores in most patients with CKP within the 1 year follow-up period. Genicular nerve t-RFA was associated with a higher probability of treatment success and a greater degree of pain relief at 1 month after the procedure when compared with c-RFA in propensity score matched patients with CKP.

Project description:BackgroundEffective symptom control in painful knee osteoarthritis (OA) may improve patient quality of life. In a randomised crossover trial (NCT03381248), COOLIEF* cooled radiofrequency ablation (CRFA) reduced pain and stiffness and improved physical function and quality of life compared with intra-articular hyaluronan (HA) injections. The present study aimed to establish the cost effectiveness of CRFA versus intra-articular HA injections for treating moderate-to-severe OA knee pain from a US Medicare perspective.MethodsWe conducted a cost-effectiveness analysis using utility data (EQ-5D) from the randomised crossover trial of CRFA versus intra-articular HA injections, which had follow-ups at 1, 3, 6, and 12 months. Patients in the HA group with unsatisfactory outcomes (e.g., continued pain) at 6 months could cross over to CRFA. Economic analysis outcomes included quality-adjusted life-years (QALYs), costs, and cost effectiveness (cost per QALY gained). Base-case analyses were modelled on a 6-month time horizon (to trial crossover). Due to limited trial data in the HA arm beyond 6 months, scenarios explored potential outcomes to 12 months if: 1) Utility with HA persisted for a further 6 months; 2) A second HA injection was received at 6 months and achieved the same utility change for the second 6 months. In both scenarios, the CRFA arm used trial data for patients who received CRFA from baseline to 12 months. Alternative costing scenarios were also explored.ResultsCRFA resulted in an incremental QALY gain of 0.020 at an incremental cost of US$1707, equating to an incremental cost-effectiveness ratio (ICER) of US$84,392 per QALY over 6 months, versus intra-articular HA injections. Extending the analysis to 12 months and assuming persistence in utility in the HA arm resulted in a larger utility gain for CRFA (0.056 QALYs) and a lower ICER of US$30,275 per QALY. If patients received a second HA injection, the incremental benefit of CRFA out to 12 months was reduced (QALY gain 0.043) but was offset by the costs of the second HA injection (incremental cost US$832). This resulted in an ICER of US$19,316 per QALY.ConclusionsCRFA is a cost-effective treatment option for patients with OA-related knee pain considering the typical US threshold of US$100,000/QALY.

Dataset Information

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.

Publications

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.

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