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NCT02734719 Clinical Trial

Increasing Bone Density by Application of Surface Electrical Stimulation

Osteoporosis Clinical Trial

Official title:
Increasing Bone Density by Application of Surface Electrical Stimulation

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02734719
Other study ID # LK-2
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date May 30, 2023

Study information
Verified date November 2023
Source University of Belgrade
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 3
Est. completion date May 30, 2023
Est. primary completion date May 30, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Bonestim
Bonestim is the multipad electrical stimulation device.

Locations
Country Name City State
Serbia Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade Belgrade

Sponsors (1)
Lead Sponsor Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome
Type Measure Description Time frame Safety issue
Primary density of bone measured by central Dxa measurement 6 months
Secondary sagittal flexibility measured by Schober measurement 6 months
Secondary daily activities measured by Oswestry disability index 6 months
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