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
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Electrical Stimulation
• Osteoporosis
• Posture

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