Dataset Information

Pilates Method and/or Photobiomodulation Therapy Combined to Static Magnetic Field in Women with Stress Urinary Incontinence: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

ABSTRACT: This clinical trial aims to provide evidence about the effectiveness of the Pilates method on stress urinary incontinence (SUI), as well as to elucidate the effects of photobiomodulation therapy associated with static magnetic field (PBMT/sMF) alone or associated with the Pilates Method on Pelvic floor muscle (PFM) in women affected by SUI. For that, a three-arm, parallel randomized, double-blinded, placebo-controlled trial was conducted (NCT05096936). We recruited thirty-three women diagnosed with SUI, randomly allocated to three groups: placebo PBMT/sMF plus method Pilates, PBMT/sMF active plus method Pilates and only PBMT/sMF active. The evaluation consisted of anamnesis and physical examination, muscle strength, completion of the ICIQ-SF questionnaire, and urinary loss. The evaluation of muscle strength and filling the ICIQ-SF were performed on the first and last days, while the Pad test was applied in baseline, one month, two months, and three months of intervention. We observed an increase in strength (p < 0.01), tone (p < 0.01), and quality of life (p < 0.01), in addition to a decrease in urinary lost (p < 0.01) for all groups comparing the pre and post-intervention. The PBMT/sMF alone, the Pilates, and the combination of the two therapies proved to be effective in improving the signs and symptoms of women with SUI.

SUBMITTER: De Marchi T

PROVIDER: S-EPMC9917687 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Pilates Method and/or Photobiomodulation Therapy Combined to Static Magnetic Field in Women with Stress Urinary Incontinence: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

De Marchi Thiago T Ferlito João Vitor JV Turra Ariane Cristina AC Flamia Sheila S de Bispo Magro Franciele F Pavelecini Donida Maribel Luiza ML Dilkin Michele M da Silva Djéssica D Massia Ribas Vanessa V Leal Junior Ernesto Cesar Pinto ECP

Journal of clinical medicine 20230131 3

This clinical trial aims to provide evidence about the effectiveness of the Pilates method on stress urinary incontinence (SUI), as well as to elucidate the effects of photobiomodulation therapy associated with static magnetic field (PBMT/sMF) alone or associated with the Pilates Method on Pelvic floor muscle (PFM) in women affected by SUI. For that, a three-arm, parallel randomized, double-blinded, placebo-controlled trial was conducted (NCT05096936). We recruited thirty-three women diagnosed w ...[more]

PMID: 36769752

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Project description:BackgroundFibromyalgia is a syndrome characterized by generalized chronic pain and tenderness in specific areas. Photobiomodulation therapy (PBMT) using low-level laser therapy and/or light emitting diode therapy is an electrophysical agent that can be used alone or together with a static magnetic field (PBMT-sMF) to promote analgesia in several health conditions. Little evidence exists regarding the effects of using PBMT and PBMT-sMF in patients with fibromyalgia; this evidence is conflicting.AimWe aimed to investigate the effects of using PBMT-sMF versus a placebo on reduction of the degree-of-pain rating, impact of fibromyalgia, pain intensity, and satisfaction with treatment in patients with fibromyalgia.DesignA prospectively registered, monocentric, randomized placebo-controlled trial, with blinding of patients, therapists, and assessors, was performed.SettingThe study was conducted at the Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT) in Brazil, between March and October 2020.PopulationNinety female patients with fibromyalgia were randomized to undergo either PBMT-sMF (N.=45) or placebo (N.=45) treatment.MethodsPatients from both groups received nine treatment sessions, three times a week, for 3 weeks. Clinical outcomes were collected at baseline, the end of treatment, and at the follow-up appointment 4 weeks post-treatment. The primary outcome was the degree-of-pain rating, measured by the reduction of the tender point count.ResultsA decrease in the degree-of-pain rating was observed in patients allocated to the PBMT-sMF group, decreasing the number of tender points when compared to placebo group at the end of treatment (P<0.0001) and at the follow-up assessment (P<0.0001). Patients did not report any adverse events.ConclusionsPBMT-sMF is superior to placebo, supporting its use in patients with fibromyalgia.Clinical rehabilitation impactPBMT-sMF might be considered an important adjuvant to the treatment regimens of patients with fibromyalgia.

Project description:BackgroundThe direct application of photobiomodulation therapy (PBMT) using low-level laser therapy (LLLT) and light emitting diodes (LEDs) combined with a static magnetic field (sMF) (PBMT-sMF) to target tissues is shown to improve muscle performance and recovery. Studies have reported possible PBMT effects when a local distant to the target tissue is irradiated. Notably, the extent of these effects on musculoskeletal performance and the optimal site of irradiation remain unclear, although this information is clinically important since these aspects could directly affect the magnitude of the effect. Therefore, we investigated the effects of local and non-local PBMT-sMF irradiations on musculoskeletal performance and post-exercise recovery before an eccentric exercise protocol.MethodsThis randomized, triple-blind (participants, therapists and assessors), placebo-controlled trial included 30 healthy male volunteers randomly assigned to the placebo, local, and non-local groups. Active or placebo PBMT-sMF was applied to 6 sites of the quadriceps muscle of both legs. An eccentric exercise protocol was used to induce fatigue. The primary outcome was peak torque assessed by maximal voluntary contraction (MVC). The secondary outcomes were delayed onset muscle soreness (DOMS) measured by visual analogue scale (VAS), muscle injury assessed by serum creatine kinase activity (CK), and blood lactate levels. Evaluations were performed before the eccentric exercise protocol (baseline), as well as immediately after and 1, 24, 48, and 72 h upon protocol completion.ResultsTen volunteers were randomized per group and analysed for all outcomes. Compared to the placebo and non-local groups, irradiation with PBMT-SMF led to statistically significant improvement (p < 0.05) with regard to all variables in the local group. The outcomes observed in the non-local group were similar to those in the placebo group with regard to all variables.The volunteers did not report any adverse effects.ConclusionOur results support the current evidence that local irradiation of all exercised muscles promotes ergogenic effects. PBMT-sMF improved performance and reduced muscle fatigue only when applied locally to muscles involved in physical activity.Trial registrationNCT03695458. Registered October 04th 2018.

Project description:The ergogenic effects of photobiomodulation therapy combined with a static magnetic field (PBMT-sMF) on exercises with characteristics similar to those of CrossFit® are unknown. This study was aimed at investigating the effects of PBMT-sMF applied at different times on recovery and physical performance in CrossFit® athletes by analyzing functional aspects, muscle damage, inflammatory processes, and oxidative stress. This was a prospectively registered, triple-blinded, placebo-controlled, crossover trial. CrossFit® athletes were recruited and assigned to receive one of the four possible interventions. Each intervention included protocols before and after the exercise (referred to as the workout of the day (WOD)). The four possibilities of intervention were as follows: placebo before and after WOD (placebo), PBMT-sMF before and placebo after WOD (PBMT-sMF before), placebo before and PBMT-sMF after WOD (PBMT-sMF after), and PBMT-sMF before and after WOD (PBMT-sMF before and after). The order of possibilities for the interventions was randomized. The primary outcome was the functional test performance. The secondary outcomes were the subjective perception of exertion, muscle damage, inflammation, and oxidative stress. The outcomes were measured before the WOD; immediately after the intervention; and 1, 24, and 48 hours after the WOD. Statistical analysis was performed using repeated measures ANOVA followed by the Bonferroni post hoc test to examine the differences between the interventions at each time point. Twelve participants were randomized and analyzed for each sequence. PBMT-sMF enhanced the performance on functional tests (calculated as a percentage of change) when applied before or after WOD in the assessment performed immediately post-WOD and at 24 and 48 hours later (p < 0.05) compared to placebo and PBMT-sMF before and after WOD. In terms of the secondary outcomes, PBMT-sMF applied before or after WOD significantly decreased the creatine kinase, catalase, and superoxide dismutase activities and interleukin-6, thiobarbituric acid, and carbonylated protein levels (all p < 0.05) compared to the other possibilities of intervention. In addition, PBMT-sMF applied before and after WOD decreased creatine kinase activity at 24 hours and IL-6 levels at 24 and 48 hours compared to placebo (p < 0.05). None of the participants reported any adverse events. PBMT-sMF enhanced the performance of functional tests, decreased the levels of biochemical markers of muscle damage and inflammation, decreased oxidative stress, and increased antioxidant activity in CrossFit® athletes when applied before or after WOD.

Project description:BackgroundEnhanced glutamatergic transmission leading to motor neuron death is considered the major pathophysiological mechanism of amyotrophic lateral sclerosis (ALS). Motor cortex excitability can be suppressed by transcranial static magnetic stimulation (tSMS), thus tSMS can be evaluated as a potential treatment for ALS. The aim of present study was to investigate the efficacy and safety of tSMS in ALS.MethodsIn this phase 2 trial, we randomly assigned ALS patients to receive daily tSMS or placebo stimulation over a period of 6 months. For each participant we calculated mean disease monthly progression rate (MPR) as the variation of the total ALS Functional Rating Scale-Revised (ALSRFS-R) score, before the beginning of the treatment (over a period of at least three months) and over the six-month treatment period. The primary efficacy outcome was the difference in MPR before and after the beginning of treatment. Secondary outcomes included safety and tolerability, compliance, and changes in corticospinal output. A long-term follow-up of 18 months was performed in all patients who completed the six-month treatment considering a composite endpoint event (tracheostomy or death). Trial registered at ClinicalTrials.gov, ID: NCT04393467, status: closed.FindingsForty participants were randomly assigned to real (n = 21) or placebo stimulation (n = 19). Thirty-two participants (18 real and 14 placebo) completed the 6-month treatment. The MPR did not show statistically significant differences between the two arms during the pre-treatment (mean ± Standard deviation; Real: 1.02 ± 0.62, Sham: 1.02 ± 0.57, p-value = 1.00) and treatment period (Real: 0.90 ± 0.55, Sham: 0.94 ± 0.55, p-value = 0.83). Results for secondary clinical endpoints showed that the treatment is feasible and safe, being compliance with tSMS high. The change in corticospinal output did not differ significantly between the two groups. At the end of the long-term follow-up of 18 months, patients of real group had a statistically significant higher tracheostomy-free survival compared with patients of placebo group (Hazard Ratio = 0.27 95% Confidence interval 0.09-0.80, p-value = 0.019).InterpretationtSMS did not modify disease progression during the 6 months of treatment. However, long-term follow-up revealed a substantial increase in tracheostomy free survival in patients treated with real stimulation supporting the evaluation of tSMS in larger and more prolonged studies.FundingThe "Fondazione 'Nicola Irti' per le opere di carità e di cultura", Rome, Italy, supported present study.

Project description:ObjectiveTo confirm if mirabegron 50 mg shows efficacy in women with overactive bladder and either urgency urinary incontinence or mixed urinary incontinence versus placebo.MethodsPost-hoc analyses were carried out using pooled data from a Japanese phase IIb and a phase III study. The primary efficacy end-point was baseline to end-of-treatment change in the mean number of micturitions/24 h. The secondary end-points were changes in the mean voided volume/micturition, mean number of urgency and incontinence episodes/24 h, and mean number of nocturia episodes/night. Other end-points were quality of life and incontinence normalization rates.ResultsWomen with urgency urinary incontinence (placebo n = 204, mirabegron n = 214) and mixed urinary incontinence (placebo n = 122, mirabegron n = 139) were included. Change in mean micturitions/24 h at end-of-treatment for mirabegron was statistically significant versus placebo in both populations; the effect size increased over time. For all secondary end-points, median changes for mirabegron were statistically significant versus placebo at end-of-treatment, except for nocturia for the urgency urinary incontinence population and urgency for the mixed urinary incontinence population. Mirabegron showed larger improvements versus placebo in all quality-of-life domains, except for general health perception in the urgency urinary incontinence population. Incontinence normalization rates for mirabegron were 47.2% and 49.6% in the urgency urinary incontinence and mixed urinary incontinence populations, respectively, versus 42.6% and 39.3% for placebo.ConclusionsMirabegron 50 mg significantly improved key overactive bladder symptoms versus placebo in women with urgency urinary incontinence, and it also improved most overactive bladder symptoms, including micturition frequency, in patients with mixed urinary incontinence. These findings support the benefits of using mirabegron in the female overactive bladder wet population.

Project description:Gait deficit is a major complaint in patients after stroke, restricting certain activities of daily living. Photobiomodulation therapy combined with a static magnetic field (PBMT-SMF) has been studied for several diseases, and the two therapies are beneficia. However, their combination has not yet been evaluated in stroke. Therefore, for PBMT-SMF to be used more often and become an adjunctive tool in the rehabilitation of stroke survivors at physical therapy rehabilitation centers and clinics, some important aspects need to be clarified. This study aimed to test different doses of PBMT-SMF, to identify the ideal dose to cause immediate effects on the spatiotemporal and kinematic variables of gait in post-stroke patients. A randomized, triple-blinded, placebo-controlled crossover pilot study was performed. A total of 10 individuals with hemiparesis within 6 months to 5 years since the occurrence of stroke, aged 45-60 years, were included in the study. Participants were randomly assigned and treated with a single PBMT-SMF dose (sham, 10 J, 30 J, or 50 J) on a single application, with one dose per stage at 7-day intervals between stages. PBMT-SMF was applied with a cluster of 12 diodes (4 of 905 nm laser, 4 of 875 nm LEDs, and 4 of 640 nm LEDs, SMF of 35 mT) at 17 sites on both lower limbs after baseline evaluation: plantar flexors (2), knee extensors (9), and flexors (6). The primary outcome was self-selected walking speed, and the secondary outcomes were kinematic parameters. Gait analysis was performed using SMART-D 140® and SMART-D INTEGRATED WORKSTATION®. The outcomes were measured at the end of each stage after the single application of each PBMT-SMF dose tested. No significant differences (p > 0.05) in spatiotemporal variables were observed between the different doses, compared with the baseline evaluation. However, differences (p < 0.05) were observed in the kinematic variable of the hip in the paretic and non-paretic limbs, specifically in the minimum flexion/extension angulation during the support phase (HMST-MIN) in doses 10 J, 30 J, and 50 J. A single application of PBMT-SMF at doses of 10 J, 30 J, and 50 J per site of the lower limbs did not demonstrate positive effects on the spatiotemporal variables, but it promoted immediate effects in the kinematic variables of the hip (maximum and minimum flexion/extension angulation during the support phase) in the paretic and non-paretic limbs in post-stroke people.

Dataset Information

Pilates Method and/or Photobiomodulation Therapy Combined to Static Magnetic Field in Women with Stress Urinary Incontinence: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Publications

Pilates Method and/or Photobiomodulation Therapy Combined to Static Magnetic Field in Women with Stress Urinary Incontinence: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

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