Effect of an educational booklet for prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial II, a study protocol of a randomized controlled trial.

BACKGROUND: This study is a part of a series of two clinical trials. We consider diabetic polyneuropathy (DPN), a common chronic and progressive complication of diabetes mellitus that has several impacts on individuals' foot health and quality of life. Based on the current trends of self-monitoring and self-care, providing a tool with foot-related exercises and educational care may help patients to avoid or reduce the musculoskeletal complications resulting from DPN, improving autonomous performance in daily living tasks. The aim of this trial is to evaluate the effects of an educational booklet for foot care and foot muscle strengthening on DPN symptoms and severity, clinical outcomes, and gait biomechanics in patients with DPN. METHODS/DESIGN: The FOotCAre (FOCA) trial II study has been designed as a single-blind, two-parallel-arm randomized controlled trial. It will include 48 patients with DPN who will be randomly allocated to a control (recommended foot care by international consensus with no foot exercises) group or an intervention (foot-related exercises using an educational booklet three times/week at home for 8 weeks) group. Participants from both groups will be assessed at baseline, after 8 weeks, and at 16 weeks for follow-up. The primary outcomes are the DPN symptoms and severity, and the secondary outcomes are foot-ankle kinematics, gait kinetics, plantar pressure distribution during gait, tactile and vibratory sensitivities, foot strength, functional balance, and foot health and functionality. DISCUSSION: The booklet is a management tool that allows users to be autonomous in their treatment by choosing how and where to perform the exercises. This allows the patients to perform the exercises regularly as a continuous habit for foot care and health, which is an important element in the management of the diabetic foot. As the booklet focuses on specific foot-ankle exercises, we expect that it will improve the clinical aspects of DPN and produce beneficial biomechanical changes during gait, becoming a powerful self-management tool that can be easily implemented to improve the performance of daily living tasks. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04008745. Registered on 2 July 2019.

Study protocol for a randomized controlled trial on the effect of the Diabetic Foot Guidance System (SOPeD) for the prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial I.

BACKGROUND: This study is part of a series of two clinical trials. Taking into account the various musculoskeletal alterations of the foot and ankle in people with diabetic peripheral neuropathy (DPN) and the need for self-care to avoid more serious dysfunctions and complications, a self-manageable exercise protocol that focuses on strengthening the foot muscles is presented as a potentially effective preventive method for foot and gait complications. The aim of this trial is to investigate the effect of a customized rehabilitation technology, the Diabetic Foot Guidance System (SOPeD), on DPN status, functional outcomes and gait biomechanics in people with DPN. METHODS/DESIGN: Footcare (FOCA) trial I is a randomized, controlled and parallel two-arm trial with blind assessment. A total of 62 patients with DPN will be allocated into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group (who will perform exercises through SOPeD at home three times a week for 12 weeks). The exercise program will be customized throughout its course by a perceived effort scale reported by the participant after completion of each exercise. The participants will be assessed at three different times (baseline, completion at 12 weeks, and follow-up at 24 weeks) for all outcomes. The primary outcomes will be DPN symptoms and severity classification. The secondary outcomes will be foot-ankle kinematics and kinetic and plantar pressure distribution during gait, tactile and vibration sensitivities, foot health and functionality, foot strength, and functional balance. DISCUSSION: As there is no evidence about the efficacy of rehabilitation technology in reducing DPN symptoms and severity or improving biomechanical, clinical, and functional outcomes for people with DPN, this research can contribute substantially to clarifying the therapeutic merits of software interventions. We hope that the use of our application for people with DPN complications will reduce or attenuate the deficits caused by DPN. This rehabilitation technology is freely available, and we intend to introduce it into the public health system in Brazil after demonstrating its effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04011267. Registered on 8 July 2019.

Respiratory Muscle Strength as a Discriminator of Sarcopenia in Community-Dwelling Elderly: A Cross-Sectional Study.

OBJECTIVES: To compare the values obtained from maximum respiratory pressures (MRP) between sarcopenic and non-sarcopenic elderly; to verify the association of maximum respiratory pressures with sarcopenia and its indicators; and to establish cut-off points for MRP as a discriminator of sarcopenia. DESIGN: Cross-sectional study. LOCATION: Macapá, Brazil. PARTICIPANTS: Community-dwelling elderly ≥ 60 years old, both sexes. MEASURES: Evaluation of respiratory muscle strength (maximal inspiratory pressure - MIP and maximal expiratory pressure - MEP) and sarcopenia, according to the European Working Group on Sarcopenia in Older People (EWGSOP), in which the diagnosis of this condition considered the reduction of muscle mass (muscle mass index - MMI) associated with muscle strength reduction (hand grip strength - HGS) and / or impairment in physical performance (gait speed - GS). RESULTS: The sample consisted of 383 elderly individuals, with a mean age of 70.02 ± 7.3 years and a prevalence of sarcopenia of 12.53% (n = 48). Sarcopenic individuals presented significantly lower (obtained, obtained versus predicted) mean values for the maximal respiratory pressures compared to the non-sarcopenic elderly, and these were inversely associated with sarcopenia (an increase by 1 cmH2O in MIP and MEP reduced by 5% and 3%, respectively, the probability of sarcopenia). In relation to the association with the sarcopenia indicators, the increase by 1 cmH2O in MIP and MEP decreased, respectively, the probability of decreasing muscle strength (3% and 2%), GS (3% and 4%) and MMI (3 % - MIP). Cut-off points ≤60 cmH2O and ≤50 cmH2O for MEP and ≤55 cmH2O and ≤45 cmH2O for MEP, respectively for elderly men and women, served as a discriminant criterion for the presence of sarcopenia (area under the ROC curve superior to 0.70). CONCLUSIONS: Elderly patients with sarcopenia had lower MIP and MEP values when compared to non-sarcopenic individuals, and respiratory muscle strength was inversely associated with the diagnosis of sarcopenia and its indicators (HGS, gait speed and MMI). Furthermore, cut-off points for MIP and MEP can be used in clinical practice as discriminators of sarcopenia in community-dwelling elderly.

Treating low back pain with combined cerebral and peripheral electrical stimulation: A randomized, double-blind, factorial clinical trial.

BACKGROUND: Recent evidence suggests that chronic low back pain is associated with plastic changes in the brain that can be modified by neuromodulation strategies. This study investigated the efficacy of transcranial direct current stimulation (tDCS) combined simultaneously with peripheral electrical stimulation (PES) for pain relief, disability and global perception in patients with chronic low back pain (CLBP). METHODS: Ninety-two patients with CLBP were randomized to receive 12 sessions on nonconsecutive days of anodal tDCS (primary motor cortex, M1), 100 Hz sensory PES (lumbar spine), tDCS + PES or sham tDCS + PES. Pain intensity (11-point numerical rating scale), disability and global perception were applied before treatment and four weeks, three months and six months post randomization. RESULTS: A two points reduction was achieved only by the tDCS + PES (mean reduction [MR] = -2.6, CI95% = -4.4 to -0.9) and PES alone (MR = -2.2, CI95% = -3.9 to -0.4) compared with the sham group, but not of tDCS alone (MR = -1.7, CI95% = -3.4 to -0.0). In addition to maintaining the analgesic effect for up to three months, tDCS + PES had a higher proportion of respondents in different cutoff points. Global perception was improved at four weeks and maintained three months after treatment only with tDCS + PES. None of the treatments improved disability and the affective aspect of pain consistently with pain reduction. CONCLUSION: The results suggest that tDCS + PES and PES alone are effective in relieving CLBP in the short term. However, only tDCS + PES induced a long-lasting analgesic effect. tDCS alone showed no clinical meaningful pain relief. SIGNIFICANCE: Transcranial direct current stimulation combined simultaneously with PES leads to a significant and clinical pain relief that can last up to three months in chronic low back pain patients. For this article, a commentary is available at the Wiley Online Library.