Back to resultsIncreasing Bone Density by Application of Surface Electrical Stimulation
Primary Purpose
Osteoporosis, Electrical Stimulation, Posture
Status
Suspended
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Bonestim
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
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
Sites / Locations
- Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group treated with Bonestim
Arm Description
The experimental group will be treated with the electrical stimulation device Bonestim.
Outcomes
Primary Outcome Measures
density of bone measured by central Dxa measurement
Secondary Outcome Measures
sagittal flexibility measured by Schober measurement
daily activities measured by Oswestry disability index
Full Information
NCT ID
NCT02734719
First Posted
March 29, 2016
Last Updated
October 31, 2022
Sponsor
University of Belgrade
1. Study Identification
Unique Protocol Identification Number
NCT02734719
Brief Title
Increasing Bone Density by Application of Surface Electrical Stimulation
Official Title
Increasing Bone Density by Application of Surface Electrical Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Suspended
Why Stopped
Device is not available.
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Belgrade
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Electrical Stimulation, Posture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group treated with Bonestim
Arm Type
Experimental
Arm Description
The experimental group will be treated with the electrical stimulation device Bonestim.
Intervention Type
Device
Intervention Name(s)
Bonestim
Other Intervention Name(s)
multipad electrical stimulation of trunk muscles
Intervention Description
Bonestim is the multipad electrical stimulation device.
Primary Outcome Measure Information:
Title
density of bone measured by central Dxa measurement
Time Frame
6 months
Secondary Outcome Measure Information:
Title
sagittal flexibility measured by Schober measurement
Time Frame
6 months
Title
daily activities measured by Oswestry disability index
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
12. IPD Sharing Statement
Learn more about this trial
Increasing Bone Density by Application of Surface Electrical Stimulation
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