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Increasing Bone Density by Application of Surface Electrical Stimulation

NCT ID: NCT02734719

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-05-30

Brief Summary

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Bonestim system for osteoporosis treatment uses surface electrical stimulation of neuromuscular and skeletal tissue by multipad stimulation electrodes for inducing contractions of the spinal column muscles. The primary aim of this clinical study is to determine if the Bonestim therapy can improve bone density. A secondary aim is to determine whether the applied treatment increases postural stability and facilitation of daily life activities.

Inducing of contractions of the spinal column muscles in this manner could be new treatment options for the patients with reduced mobility and the patients with serious contraindications for drugs.

Detailed Description

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Conditions

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Osteoporosis Electrical Stimulation Posture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group treated with Bonestim

The experimental group will be treated with the electrical stimulation device Bonestim.

Group Type EXPERIMENTAL

Bonestim

Intervention Type DEVICE

Bonestim is the multipad electrical stimulation device.

Interventions

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Bonestim

Bonestim is the multipad electrical stimulation device.

Intervention Type DEVICE

Other Intervention Names

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multipad electrical stimulation of trunk muscles

Eligibility Criteria

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Inclusion Criteria

* T score at least 1,5 (ideal 2,-2,5)
* Stable bone turn over (lab.analyses.)

Exclusion Criteria

* fracture,pace maker, malignancy and gastrointestinal problems
* chronic corticosteroid therapy
* spinal surgery in previous year
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Belgrade

OTHER

Sponsor Role lead

Responsible Party

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Konstantinovic Ljubica

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade

Belgrade, , Serbia

Site Status

Countries

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Serbia

Other Identifiers

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LK-2

Identifier Type: -

Identifier Source: org_study_id