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Effect Of Bioelectric Therapy On Sternal Instability In Patients With Median Sternotomy After Heart Valve Surgery

Effect Of Bioelectric Therapy On Sternal Instability In Patients With Median Sternotomy After Heart Valve Surgery: A Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04949581
Acronym
SI
Enrollment
40
Registered
2021-07-02
Start date
2021-07-15
Completion date
2021-09-30
Last updated
2021-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Valve Surgery

Keywords

bioelectric therapy, median sternotomy, heart valve surgery

Brief summary

The aim of this study is to investigate the effect of bioelectric therapy on sternal instability in patients with median sternotomy after heart valve surgery.

Detailed description

Valvular heart disease constitutes a growing healthcare problem with a general prevalence of 2%-5% and a prevalence of 13% after the age of 75 years Heart valve surgery can be a lifesaving procedure for patients with severe symptomatic heart valve disease. Nevertheless, following the surgery, up to 27% of patients may require readmission within 30 days after discharge. Following heart valve surgery, some patients report anxiety and worries related to readmission and reoperations, postoperative complications, and deconditioning which may prevent or delay return to work and limit activities of daily living.Over the past 30 years, bone-growth stimulators have become a critical component in fracture care. They can be classified into four categories: direct-current (DC) devices, inductive coupling, noninvasive capacitive coupling, and low-intensity ultrasound. Microcurrent electrical stimulation ( MES) is the therapeutic use of constant (DC) and pulsed (interrupted) currents, where the stimulus amplitude is in the micro amperage (millionth of an ampere) range. MES is defined as those of less than 1 mA or 1000 μ, (MES \< 1 mA). This form of electrical stimulation tends to be applied at the suspensory or very low sensory level and they are not designed to stimulate muscle contraction. Generators that produce MES were originally called microcurrent electrical neuromuscular stimulators (MENS). However, the stimulation pathway is not the usual neural pathway, and they are not designed to stimulate muscle contraction. Consequently, this type of generator was subsequently referred to as a microcurrent electrical stimulator (MES). The use of MES may be an adjunctive modality in the treatment of fractures or injury sites, especially fractures prone to nonunion. Fracture healing may be accelerated by passing a monophasic current through the fracture site. Getting the current into the bony area without an invasive technique is difficult.forty subjects will be allocated to two groups; one group will receive micro-current therapy and routine cardiac rehabilitation program both for four weeks and the control group will receive the cardiac rehabilitation program only for four weeks.

Interventions

OTHERbioelectric therapy

the patient will receive microcurrent therapy from a supine lying position. the negative electrode on the incision area and the positive electrode proximal. the intensity will be less than 20 microamperes and frequency at 20 HZ.

the patient will receive cardiac rehabilitation program

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

random generator

Intervention model description

bioelectric therapy and routine cardiac rehabilitation program

Eligibility

Sex/Gender
ALL
Age
40 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

1. there age between 40 and 50 years, 2. hemodynamic stability 3. BMI from 25 to 29.9 kg/m2, 4. they will have acute sternal instability.

Exclusion criteria

1. previous thoracic surgery 2. elective and urgent coronary artery bypass surgery 3. respiratory insufficiency after surgery manifesting hypoxemia with partial pressure of oxygen in arterial blood \<60 mmHg 4. renal insufficiency with serum creatinine ≥1.8 mg/dl after surgery 5. low cardiac output syndrome with ST segment elevation in multiple electrocardiogram leads, cardiac arrhythmias, or hypotension, according to the American College of Cardiology Foundation and American Heart Association

Design outcomes

Primary

MeasureTime frameDescription
sternal instabilityup to four weekssternal instability scale will be used for assessment. this scale has four points. zero mean more stability and three mean completly separated

Secondary

MeasureTime frameDescription
sternal separationup to four weeksultrasound unit will be used for assessing the separation between sternum edges

Contacts

Primary Contactal shaymaa sh abd el azeim, lecturer
alshaymaa.shaaban@pt.cu.edu.eg01033771553
Backup Contactal shaymaa sh abd el azeim, lecturer
alshaymaa.ahaaban@pt.cu.edu.eg01033771553

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026