Increasing Bone Density by Application of Surface Electrical Stimulation

Sponsor
University of Belgrade (Other)
Overall Status
Suspended
CT.gov ID
NCT02734719
Collaborator
(none)
10
1
1
15
0.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Bonestim
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Increasing Bone Density by Application of Surface Electrical Stimulation
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group treated with Bonestim

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

Device: Bonestim
Bonestim is the multipad electrical stimulation device.
Other Names:
  • multipad electrical stimulation of trunk muscles
  • Outcome Measures

    Primary Outcome Measures

    1. density of bone measured by central Dxa measurement [6 months]

    Secondary Outcome Measures

    1. sagittal flexibility measured by Schober measurement [6 months]

    2. daily activities measured by Oswestry disability index [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade Belgrade Serbia 11000

    Sponsors and Collaborators

    • University of Belgrade

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Konstantinovic Ljubica, professor, University of Belgrade
    ClinicalTrials.gov Identifier:
    NCT02734719
    Other Study ID Numbers:
    • LK-2
    First Posted:
    Apr 12, 2016
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 18, 2022