Search

Context: Although opioids and pregabalin are widely used for cancer-related neuropathic pain (CNP), no clinical trials exist to determine which medications are effective when an opioid-pregabalin combination therapy fails.Objectives: We investigated the efficacy of duloxetine for CNP nonresponsive or intolerant to opioid-pregabalin combination therapy.Methods: A multicenter, randomized, double-blind, placebo-controlled trial was performed at 12 specialized palliative care services in Japan. Patients with CNP average pain scores (Brief Pain Inventory [BPI]-Item 5) ≥ 4 in the previous 24 hours and nonresponsive or intolerant to opioid-pregabalin combination therapy were eligible. Patients with chemotherapy-induced peripheral neuropathies were excluded. Patients were administered duloxetine 20 mg/day titrated to 40 mg/day or placebo for 10 days. The primary endpoint was BPI-Item 5 on Day 10. Responder analysis measured proportions of patients with 30% and 50% pain decreases.Results: Seventy patients were enrolled. Complete case analysis revealed mean BPI-Item 5 on Day 10 of 4.03 for Group D vs. 4.88 for Group P (P = 0.053). Baseline observation carried forward analysis revealed mean BPI-Item 5 on Day 10 of 4.06 and 4.91 for Groups D and P, respectively (P = 0.048). Clinically meaningful pain improvement (≥30%) was reported by 44.1% (n = 15) of patients in Group D vs. 18.2% (n = 6) in Group P (P = 0.02); 32.4% (n = 11) vs. 3.0% (n = 1) of patients in Groups D and P, respectively, reported pain reduction ≥ 50% (P = 0.002).Conclusion: Adding duloxetine to opioid-pregabalin therapy might have clinical benefit in alleviating refractory CNP. Further studies are needed to conclude the efficacy of adding duloxetine. [ABSTRACT FROM AUTHOR]

Background: Developing health services is a key strategy for improving the community health provided by public health nurses. However, an effective educational program for improving their skills in planning such services has not been developed. To describe our program and its evaluation protocol for the education of middle-level public health nurses to improve their skills in developing new health services to fulfil community health needs in Japan. Methods: In this randomized control trial, eligible participants in Japan will be randomly allocated to an intervention group and a control wait-list group. We will provide 8 modules of web-based learning for public health nurses from July to October 2018. To ensure fairness of educational opportunity, the wait-list group will participate in the same program as the intervention group after collection of follow-up data of the intervention group. The primary outcomes will be evaluated using the scale of competency measurement of creativity for public health nurses at baseline, immediately after the intervention. Secondary outcomes will be knowledge and performance regarding program development of public health nurses. Discussion: This study will enable the analysis of the effects of the educational program on public health nurses for improving their competency to develop new health services for fulfilling community health needs and enriching health care systems. Trial registration: We registered our study protocol to the University hospital Medical Information Network- Clinical Trials Registry approved by International Committee of Medical Journal Editors (No. UMIN000032176, April, 2018). [ABSTRACT FROM AUTHOR]