Scrambler therapy improves pain in neuromyelitis optica: A randomized controlled trial.

OBJECTIVE: To determine whether Scrambler therapy is an effective, acceptable, and feasible treatment of persistent central neuropathic pain in patients with neuromyelitis optica spectrum disorder (NMOSD) and to explore the effect of Scrambler therapy on co-occurring symptoms. METHODS: We conducted a randomized single-blind, sham-controlled trial in patients with NMOSD who have central neuropathic pain using Scrambler therapy for 10 consecutive weekdays. Pain severity, pain interference, anxiety, depression, and sleep disturbance were assessed at baseline, at the end of treatment, and at the 30- and 60-day follow-up. RESULTS: Twenty-two patients (11 per arm) were enrolled in and completed this trial. The median baseline numeric rating scale (NRS) pain score decreased from 5.0 to 1.5 after 10 days of treatment with Scrambler therapy, whereas the median NRS score did not significantly decrease in the sham arm. Depression was also reduced in the treatment arm, and anxiety was decreased in a subset of patients who responded to treatment. These symptoms were not affected in the sham arm. The safety profiles were similar between groups. CONCLUSIONS: Scrambler therapy is an effective, feasible, and safe intervention for central neuropathic pain in patients with NMOSD. Decreasing pain with Scrambler therapy may additionally improve depression and anxiety. CLINICALTRIALSGOV IDENTIFIER: NCT03452176. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that Scrambler therapy significantly reduces pain in patients with NMOSD and persistent central neuropathic pain.

Corrie Health Digital Platform for Self-Management in Secondary Prevention After Acute Myocardial Infarction.

BACKGROUND: Unplanned readmissions after hospitalization for acute myocardial infarction are among the leading causes of preventable morbidity, mortality, and healthcare costs. Digital health interventions could be an effective tool in promoting self-management, adherence to guideline-directed therapy, and cardiovascular risk reduction. A digital health intervention developed at Johns Hopkins-the Corrie Health Digital Platform (Corrie)-includes the first cardiology Apple CareKit smartphone application, which is paired with an Apple Watch and iHealth Bluetooth-enabled blood pressure cuff. Corrie targets: (1) self-management of cardiac medications, (2) self-tracking of vital signs, (3) education about cardiovascular disease through articles and animated videos, and (4) care coordination that includes outpatient follow-up appointments. METHODS AND RESULTS: The 3 phases of the MiCORE study (Myocardial infarction, Combined-device, Recovery Enhancement) include (1) the development of Corrie, (2) a pilot study to assess the usability and feasibility of Corrie, and (3) a prospective research study to primarily compare time to first readmission within 30 days postdischarge among patients with Corrie to patients in the historical standard of care comparison group. In Phase 2, the feasibility of deploying Corrie in an acute care setting was established among a sample of 60 patients with acute myocardial infarction. Phase 3 is ongoing and patients from 4 hospitals are being enrolled as early as possible during their hospital stay if they are 18 years or older, admitted with acute myocardial infarction (ST-segment-elevation myocardial infarction or type I non-ST-segment-elevation myocardial infarction), and own a smartphone. Patients are either being enrolled with their own personal devices or they are provided an iPhone and/or Apple Watch for the duration of the study. Phase 3 started in October 2017 and we aim to recruit 140 participants. CONCLUSIONS: This article will provide an in-depth understanding of the feasibility associated with implementing a digital health intervention in an acute care setting and the potential of Corrie as a self-management tool for acute myocardial infarction recovery.

Recruitment of African American and white postmenopausal women into clinical trials: the beneficial effects of soy trial experience.

OBJECTIVE: To describe the strategies and costs associated with recruiting both African American and White postmenopausal women into a randomized controlled trial. DESIGN: The Beneficial Effects of Soy Trial (BEST) was a randomized, controlled trial designed to determine the effects of a dietary soy supplement on lipoproteins, lipoprotein subclasses, and menopausal symptoms in African American and White postmenopausal women. The goal was to have > or = 80 African American and > or = 80 White women complete the study. RESULTS: A total of 705 postmenopausal women (381 African American, 324 White) were screened, and of those, 217 were randomized (105 African American, 112 White), and 192 (91 African American, 101 White) completed the study. Direct mailings to targeted zip codes proved the most successful recruitment strategy for recruiting African Americans (52% of African Americans recruited) and the second most effective for recruiting Whites (32% of Whites recruited). Newspaper advertisements yielded the highest number of White participants (36%) but proved less successful for recruiting African Americans (8%). Airing advertisements on the radio was the second most effective strategy for recruiting African Americans (15%), yet it was one of the least effective approaches for recruiting Whites (5%). The total cost of recruitment was dollar 49,036.25, which averaged dollar 255.40 per participant who completed the study. The three most successful strategies, direct mailings, newspaper ads, and radio ads, were the three most expensive approaches but yielded 73% of all participants who completed the study.