Increasing Bone Density by Application of Surface Electrical Stimulation

Not Applicable

Terminated

• Conditions: Osteoporosis; Electrical Stimulation; Posture
• Interventions: Device: Bonestim

• Registration Number: NCT02734719
• Lead Sponsor: University of Belgrade

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-12
• Study Start: 2021-10-01
• Primary Completion: 2023-05-30
• Study Completion: 2023-05-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
density of bone measured by central Dxa measurement	6 months

Secondary Outcome Measures

Name	Time	Method
sagittal flexibility measured by Schober measurement	6 months
daily activities measured by Oswestry disability index	6 months

Trial Locations

Locations (1)

Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade; 🇷🇸 Belgrade, Serbia