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Abstract Background The efficacy and tolerability of 500-730 kDa sodium hyaluronate (Hyalgan®) for treatment of osteoarthritis (OA) pain has been established in clinical trials, but few data are available in the Asian population. We conducted a randomized, double-blind, multicenter, placebo-controlled study to evaluate the efficacy and tolerability of this preparation in a Taiwanese population. Methods Two hundred patients with mild to moderate OA of the knee were randomized to receive five weekly intra-articular injections of sodium hyaluronate or placebo. The primary efficacy outcome was the change from baseline to Week 25 in patients' evaluation of pain using a 100-mm visual analog scale (VAS) during the 50-foot walking test. Additional outcomes included Western Ontario and McMaster Universities (WOMAC) scores, time on the 50-foot walking test, patient's and investigator's subjective assessment of effectiveness, acetaminophen consumption, and the amounts of synovial fluid. Results The Hyalgan® treatment group showed a significantly greater improvement from baseline to Week 25 in VAS pain on the 50-foot walking test than the placebo group (p = 0.0020). The Hyalgan® group revealed significant improvements from baseline to week 25 in WOMAC pain and function score than the placebo group (p = 0.005 and 0.0038, respectively) Other outcomes, such as time on the 50-foot walking test and subjective assessment of effectiveness, did not show any significant difference between groups. Both groups were safe and well tolerated. Conclusions The present study suggests that five weekly intra-articular injections of sodium hyaluronate are well tolerated, can provide sustained relief of pain, and can improve function in Asian patients with osteoarthritis of the knee. Level of Evidence Therapeutic study, Level I-1a (randomized controlled trial with a significant difference). Trial registration ClinicalTrials.gov Identifier: NCT01319461

Abstract Background An irregular bedtime schedule is a prevalent problem in young adults, and could be a factor detrimentally affecting sleep quality. The goal of the present study was to explore the association between an irregular bedtime schedule and sleep quality, daytime sleepiness, and fatigue among undergraduate students in Taiwan. Methods A total of 160 students underwent a semi-structured interview and completed a survey comprising 4 parts: Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Fatigue Severity Scale (FSS), and a rating of irregular bedtime frequency. Participants were grouped into 3 groups in terms of irregular bedtime frequency: low, intermediate, or high according to their 2-week sleep log. To screen for psychological disorders or distress that may have affected responses on the sleep assessment measures, the Chinese health questionnaire-12 (CHQ-12) was also administered. Results We found an increase in bedtime schedule irregularity to be significantly associated with a decrease in average sleep time per day (Spearman r = -0.22, p = 0.05). Multivariate regression analysis revealed that irregular bedtime frequency and average sleep time per day were correlated with PSQI scores, but not with ESS or FSS scores. A significant positive correlation between irregular bedtime frequency and PSQI scores was evident in the intermediate (partial r = 0.18, p = 0.02) and high (partial r = 0.15, p = 0.05) frequency groups as compared to low frequency group. Conclusion The results of our study suggest a high prevalence of both an irregular bedtime schedule and insufficient sleep among university students in Taiwan. Students with an irregular bedtime schedule may experience poor sleep quality. We suggest further research that explores the mechanisms involved in an irregular bedtime schedule and the effectiveness of interventions for improving this condition.

Abstract Background Metatarsalgia is related to repetitive high-pressure loading under the metatarsal head (MH) that causes pain. The high pressure under the MH can be reduced by adequately applying metatarsal pads (MPs). Plantar pressure measurements may provide a method to objectively evaluate pressure loading under the MH. However, it is still unclear if the decrease in plantar pressure under the MH after MP treatment is associated with subjective improvement. This study aims to explore the correlations between subjective pain improvement and outcome rating, and the plantar pressure parameters in metatarsalgia patients treated using MPs. Methods Thirteen patients (a total of 18 feet) with secondary metatarsalgia were included in this study. Teardrop-shaped MPs made of polyurethane foam were applied just proximal to the second MH by an experienced physiatrist. Insole plantar pressure was measured under the second MH before and after MP application. Visual analog scale (VAS) scores of pain were obtained from all subjects before and after 2 weeks of MP treatment. The subjects rated using four-point subjective outcome scales. The Wilcoxon signed-rank test was used to analyze the difference between the plantar pressure parameters and VAS scores before and after treatment. The Kruskal-Wallis test was applied to compare the plantar pressure parameters in each outcome group. Pearson's correlation was applied to analyze the correlation between the changes in plantar pressure parameters and VAS scores. Statistical significance was set as p < 0.05. Results MP application decreased the maximal peak pressure (MPP) and pressure-time integral (PTI) under the second MH and also statistically improved subjective pain scores. However, neither the pre-treatment values of the MPP and PTI shift in the position of the MPP after treatment, nor the age, gender and body mass index (BMI) of the subjects were statistically correlated with subjective improvement. Declines in the PTI and MPP values after MP application were statistically correlated with the improvement in VAS scores (r = 0.77, R2 = 0.59, p < 0.001; r = 0.60, R2 = 0.36, p = 0.009). Conclusion We found that the successful decline in the PTI and MPP under the second MH after MP application was correlated to subjective pain improvement. This study provides a strategy for the further design and application of MPs for metatarsalgia treatment.