Venous Thrombosis
Conditions
Interventions
A clinical, interventional, prospective, single-center, randomized, single-blind study was carried out to evaluate the effect of neuromuscular electrical stimulation with the IBRAMED NEURODYN™ II devi
c) M2 – Moment of electrical stimulation, lasting 20 minutes, d) M3 – Moment immediately after M2, e) M4 – 120 minutes after the end of M2 and f) M5 – 240 minutes after the end of M2. At moment 0, the
E02.331.800
Sponsors
Departamento de Cirurgia e Ortopedia da Faculdade de Medicina de Botucatu
Departamento de Cirurgia e Ortopedia da Faculdade de Medicina de Botucatu
Eligibility
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Being between 18 and 40 years old. Both genders. Sign the Free and Informed Consent Form. Have a Body Mass Index (BMI) between 18 and 34 kg/m2
Exclusion criteria
Exclusion criteria: Use of illicit drugs in the last 12 months. Use of the following medications in the last 24 hours: medicines for headache with vascular effect, such as sumatriptan, ergot derivatives, isomeptene, etc, analgesics such as dipyrone and paracetamol, non-steroidal anti-inflammatory drugs such as ibuprofen, naproxen, diclofenac, etc. Consumption of foods in the last 24 hours with a known effect on vascular reactivity, according to the list: coffee, folic acid, vitamin C, high doses of fish oil, vitamin supplements, fruits and vegetables in large quantities such as cranberries (also known as cranberries) and grapefruit (also known as grapefruit), beets and black currants, wine, tea, cocoa and derivatives, chocolate and hazelnuts, natural grape and orange juice, cheese, probiotics (foods with this effect), capsaicin, like pepper, energy drinks, beer. Any significant illness within the last 4 weeks of exposure. Pregnancy or lactation. Use of hormonal contraceptive method, including IUD etc., in the last 3 months. Active smoker or ex-smoker in the last 12 months. History of peripheral arterial obstructive disease. Ankle-brachial index less than 0.9, defined in anamnesis and physical examination. History of chronic venous insufficiency in the lower limbs. Ulcer on lower limbs. History of venous thromboembolism. History of fracture or presence of metallic implants in lower limbs. Have an infection at the electrode implantation site. Have participated in a drug or medical device study up to 4 weeks previously. Use of any neuro-modulating device. Surgery 3 months before the study (such as abdominal, gynecological, etc.). Trauma to the lower limbs that may prevent correct electrical stimulation of the common peroneal nerve. Use of a pacemaker or implantable cardioverter-defibrillator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome found 1: Of all the study variables, the vessel diameter was the one that proved to be most sensitive to electrical stimulation. There was an increase in diameter in all vessels analyzed, including at moments M4 and M5. The diameters varied without statistical difference between the stimulated and non-stimulated limb, which allowed joint analysis of the data and suggests a systemic effect of NMES. This occurred regardless of the fact that the variation in flow volume was not significant, which suggests that it was not just a dilation caused by the flow. The continuous increase in the diameter of the popliteal arteries (the largest median was found in M5) suggests a prolonged residual effect caused by NMES, which continued even after the end of stimulation. Flow velocities varied without statistical difference between limbs over time, except for the popliteal vein. Only the femoral vessels had significant changes in arterial and venous flow velocities. The velocities in the popliteal vessels varied positively, but not significantly. The clinical significance of increased flow favors the use of the technique in therapies that require increased flow, such as in the prevention of VTE and as a possible therapy for CVI and PAD. There was variation in both the stimulated and non-stimulated limbs, with no statistical difference between them over time. The variation in flow volume in the joint analysis of the limbs for the popliteal vein, between M4 and M1 and between M5 and M4, was statistically significant, which suggests a late effect of NMES.;Expected outcome 2: Effects on the fibrinolytic system through laboratory analysis of serum dosage of tissue plasminogen activator and serum dosage of type-1 plasminogen activator inhibitor.;Outcome found 2: The effects on the fibrinolytic system through laboratory analysis of serum t-PA dosage and serum PAI-1 dosage had no statistically significant change. t-PA changed numerically, with a continuous increase, and reached an | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 4: The safety and tolerability of the use of electrical stimulator equipment in healthy individuals through the presence of adverse events and tolerance score.;Outcome found 4: The safety and tolerability of using this electrical stimulator equipment was proven by the absence of adverse events and that all individuals gave the lowest tolerance score (no sensation of discomfort), something also different from the studies cited in the introduction of this work. The experiment was considered tolerable by all individuals (everyone gave the lowest possible score for discomfort) | — |
Countries
Brazil
Contacts
Public ContactJamil Mariúba
Universidade Estadual Paulista UNESP - Faculdade de Medicina de Botucatu
Outcome results
None listed