Increasing Bone Density by Application of Surface Electrical Stimulation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Belgrade
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- density of bone measured by central Dxa measurement
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- 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
Arms & Interventions
Group treated with Bonestim
The experimental group will be treated with the electrical stimulation device Bonestim.
Intervention: Bonestim (Device)
Outcomes
Primary Outcomes
density of bone measured by central Dxa measurement
Time Frame: 6 months
Secondary Outcomes
- sagittal flexibility measured by Schober measurement(6 months)
- daily activities measured by Oswestry disability index(6 months)
Investigators
Konstantinovic Ljubica
professor
University of Belgrade