Primary dysmenorrhea is considered one of the main causes of pelvic pain during a woman’s childbearing years, resulting in poor quality of life. The objective was to evaluate the effectiveness of transcutaneous tibial nerve stimulation (TTNS) in painful symptomatology improvement and non-steroidal anti-inflammatory drug (NSAID) intake reduction in women with primary dysmenorrhea (PD) compared with a control group in the short, medium, and long terms. A single-blind, controlled clinical trial was developed. Participants were randomized to the experimental (TTNS) and control group (sham TTNS). Both groups received 12-weekly 30-min sessions with a NeuroTracTM PelviTone electrostimulation device. The intensity and severity of pain and non-steroidal anti-inflammatory drug (NSAID) intake were evaluated in the short-term (after treatment), medium-term (1–3 months), and long-term (6 months). A total of 61 participants were randomized, with a split of 31 (experimental group) and 30 (control group), but 55 participants completed the study and were analyzed. Statistically significant differences between both groups in the maximum pain intensity decrease (F = 4.88, p = 0.0043) measured with the visual analogue scale, as well as NSAID intake decrease (F = 4.68, p = 0.011) and days of their ingestion (F = 4.57, p = 0.012) occurred in the short term. Furthermore, significant decreases in the total number of NSAIDs ingested during the cycle (F = 3.82, p = 0.011) and the number of days on which patients ingested NSAIDs (F = 3.59, p = 0.015) in the medium–long term occurred. TTNS could be an effective and safe strategy to reduce pain caused by PD, which could reduce or complement the use of pharmacological techniques and other more invasive methods.
Primary dysmenorrhea (PD) is a painful menstruation that can persist for the duration of a woman’s fertile life. Non-steroidal anti-inflammatory drugs, hormonal therapy, physiotherapy techniques, etc., are the main treatments. The main objective of this study is to evaluate the effectiveness of transcutaneous posterior tibial nerve stimulation (TTNS) in PD patients. The study will consist of a single-blind randomized clinical trial, parallel-assigned with two arms. Women with PD (18–43 years) with regular menstrual cycles and at least 4 points in VAS will be randomly divided into experimental (TTNS) and placebo (simulated stimulation) groups during 12 treatment sessions (1 session/week) and several follow-ups: monthly during treatment and 1, 3 and 6 months after. Maximum and mean pain intensity, pain duration, pain severity, number of anti-inflammatory drugs, quality of life, sleep quality, overall improvement, treatment satisfaction and secondary effects will be measured once a month every 6 months and at 3 and 6 months. The Student’s t-test for independent samples or the Mann–Whitney U test will be used. The literature shows effective physiotherapeutic techniques for PD in the short term, which do not act on causes and have limitations. The TTNS technique can be used in transcutaneous and percutaneous modalities, with similar effectiveness, but the transcutaneous causes less discomfort. TTNS modulates pain, and long-term benefits could be achieved at low cost and without patient discomfort.
Background: Primary dysmenorrhea is a leading cause of chronic cyclic pelvic pain, contributing to a reduced quality of life and sleep disturbances in women. The objective of this study was to assess the effectiveness of transcutaneous tibial nerve stimulation (TTNS) in improving the quality of life, sleep, and overall health perceptions of participants compared to a control group of women with dysmenorrhea over short-term, medium-term, and long-term periods. Methods: A single-blind, controlled clinical trial was conducted, with participants randomly assigned to an experimental group (receiving TTNS) or a control group (receiving sham TTNS). Both groups underwent 12, weekly 30 min sessions using the NeuroTrac™ PelviTone electrostimulation device. Outcomes related to quality of life, sleep deficiency, and overall improvement were evaluated at three time points: short-term (post-treatment), medium-term (1–3 months), and long-term (6 months). Results: Of the 61 participants initially randomized (31 in the experimental group and 30 in the control group), 55 completed the study and were included in the final analysis. A statistically significant improvement was observed in the experimental group in both physical and mental health components, as measured by the SF-36v2® questionnaire, following 12 weeks of intervention, compared to the control group, persisting 6 months after the intervention. Additionally, statistically significant differences in overall improvement were noted between the two groups, as measured by the PGIC questionnaire at the end of treatment (p = 0.0103) and 6 months post-treatment (p = 0.0432). Conclusions: TTNS appears to be a safe and effective strategy for enhancing quality of life and overall health in women with PD, potentially reducing the reliance on pharmacological treatments or more invasive methods.
Background: Cancer cachexia and sarcopenia are highly prevalent complications affecting up to 50% of patients with cancer and are associated with increased treatment toxicity, poorer functional outcomes, and reduced survival. Early identification of muscle deterioration during hospitalization remains challenging. Objective: To evaluate the change in dominant-hand handgrip strength between hospital admission and discharge in hospitalized oncology patients. Methods: This prospective longitudinal study will evaluate hospitalized adults with confirmed malignancy and an expected hospital stay of ≥5 days. Daily handgrip strength and sEMG assessments will be performed as exploratory secondary measures to characterize temporal patterns of muscle function during hospitalization. Baseline and discharge evaluations will additionally include bioelectrical impedance analysis, validated patient-reported outcome measures (SARC-F, EORTC QLQ-C30, PSQI), and serum biomarkers related to inflammatory and nutritional status. Linear mixed models will be used to evaluate longitudinal changes and associations between functional, electrophysiological, and biochemical parameters. Expected results: The study aims to characterize trajectories of muscle function decline during hospitalization, identify candidate biomarker signatures for cachexia detection, and evaluate neuromuscular fatigue patterns using sEMG. Conclusions: This protocol proposes a feasible multimodal framework for monitoring skeletal muscle deterioration during acute oncology hospitalization and may inform future interventional strategies targeting cancer-related cachexia and sarcopenia.
This study evaluated the long-term changes induced by wearing minimalist footwear (MF) during activities of daily living (ADLs) on the plantar footprint and postural stability in healthy adults. In this randomized clinical trial, a total of 95 healthy adults were recruited; 90 participants completed the protocol and were analyzed in either an experimental group (EG, n = 45), which wore MF for at least 5 h per day over a 6-month period, or a passive control group (CG, n = 45). Plantar pressure distribution (forefoot, rearfoot, and total contact areas), static stability (center of pressure (CoP) displacement under open-eyes and closed-eyes conditions), and dynamic stability (forward reach test) were assessed using a force platform at baseline and post-intervention. A self-reported questionnaire and an adverse event record were also completed by the EG. Statistical analysis was carried out using a repeated-measures analysis of variance (ANOVA) and a paired Student’s t-test; statistical significance level was set at p < 0.05. The Group Time interaction analysis revealed no statistically significant between-group differences across the evaluated parameters. However, within-group analysis showed a significant increase in CoP displacement under the open-eye condition in the CG (), indicating a decline in baseline postural efficiency, whereas the EG maintained structural and posturographic stability. Regarding user feedback, comfort (44.4%) was highlighted as the primary advantage, aesthetics (77.8%) was the main drawback, and 70% of the participants intended to continue using MF. Only two minor, transient adverse events were recorded. In conclusion, a 6-month program of MF use during ADLs did not produce any statistically significant changes in plantar footprint or stability in healthy adults.