OsteoporosisNCT01430858
Does Vibration Therapy Induce Higher Than Normal Bone Strains and Strain Rates Than Those Experienced During Habitual Daily Activities
A study testing Strain Gauge and Vibration therapy in people with Osteoporosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The overall aim of this study is to test the hypothesis that vibration exercise can induce higher than normal bone strains and strain rates than are experienced during habitual locomotor activities. The investigators plan to study healthy young volunteers to: 1. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Strain Gauge and Vibration therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female volunteers, ages 18 to 50 years
- Generally healthy, as determined by review of medical history and physical exam
- Ambulatory
- Willing and physically able to undergo all study procedures
- BMD (measured by DXA) at the lumbar spine and hip within ± 2 SD of the young normal range
- BMI < 30
Who cannot join
- Previous diagnosis of osteoporosis
- History of fracture of the spine, pelvis, leg or foot
- History of bone or joint disorders affecting the shoulders, spine, pelvis, legs or feet (e.g. arthritis, congenital hip dislocation, spinal spondylolisthesis)
- Ongoing conditions or diseases known to cause secondary osteoporosis
- Malabsorption syndromes (e.g. coeliac or Crohn's disease)
- Known disorders of calcium metabolism
Show all 25Show fewer
- Known history of thyroid disease
- Osteomalacia
- Paget's disease
- Diabetes
- History of cancer within the previous 5 years
- Epilepsy
- Ongoing conditions or use of medications that may impair vision or balance
- Use of the following medications within the previous 2 years
- Bisphosphonates
- Fluoride (except use for oral hygiene)
- Strontium
- Teriparatide
- Other bone agents (e.g. SERMs, isoflavones, HRT, calcitonin etc)
- Steroids
- Alcohol abuse or illicit drug use
- Pregnancy or currently trying to conceive (women only)
- Inability to give informed consent
- Known hypersensitivity to the antibiotic penicillin or cephalosporins
- Known hypersensitivity to the local anaesthetic lignocaine.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Academic Unit of Bone Metabolism
Sheffield, South Yorks, S5 7AU
About this study
Official title: Measurement of Induced Strains in the Human Tibia During Vibration Therapy and Habitual Activities
The overall aim of this study is to test the hypothesis that vibration exercise can induce higher than normal bone strains and strain rates than are experienced during habitual locomotor activities.
The investigators plan to study healthy young volunteers to:
Read more
- Determine the relationship between tibial bone strain and
- the frequency and amplitude of vibration therapy
- a range of habitual locomotor activities;
- Determine the transmission of vibrations during vibration therapy, in terms of
- amplitude attenuation and phase shift of positional coordinates and accelerations at anatomic landmarks along the lower leg and other skeletal sites
- the relationship between these and different frequencies and amplitudes of vibration therapy;
- Determine the muscle power in the lower limb associated with various habitual locomotor activities and its relationship to the measured tibial bone strain.
The investigators subsequently hope to use the data captured in this experiment to develop a QCT-based finite element (FE) model of the human lower limb (tibia, fibula and foot). The investigators will then validate this model in relation to the characteristics (amplitude and phase shift) of the measured tibial bone strain and transmission of vibrations to the different anatomical landmarks during vibration therapy.
- Conditions
- Osteoporosis
- Being tested
- Strain Gauge, Vibration therapy
- Keywords
- Fracture, Anabolic, Vibration, Strain Gauge, Focus - Osteoporosis
- Medical subject headings
- Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strain GaugeDevice
Also called Rosette strain gauge (FRA-2-11 Tokyo Sokki Kenkyujo Co., Japan)
The study participants will each undergo sterile surgical implantation of a tibial bone strain gauge in the right leg (dominance will recorded and determined by handedness). A single stacked, 45°, rosette strain gauge (FRA-2-11 Tokyo Sokki Kenkyujo Co., Japan) will be unilaterally bonded to the medial tibial cortex and carefully aligned with the long axis of the tibia. The gauge will be attached at the mid-shaft region, to determine the transmission of the vibrations through the bone and quantification of the microstructural effect.
Vibration therapyOther
Also called Galileo 900 platform (Novotec Medical GmbH, Medical device CE0123), Juvent 1000 platform (CE-marked), Power Plate Pro5 (CE-marked)
Galileo 900 platform. Study subjects will be asked to stand on the device for a series of 36 tests, with vibrations applied at various frequencies and amplitudes. A 20-second duration of videomotion \& strain gauge readings will be captured.
Juvent 1000 platform The volunteers will stand on the platform for one minute during which a 20-second duration of videomotion \& strain gauge readings will be captured.
Power Plate Pro5 Two amplitude settings will be tested, described as low \& high. The subject will stand on each platform test for up to 1 minute, during which a 20-second duration of videomotion \& strain gauge readings will be captured.
| Study group | Role | What they receive |
|---|---|---|
| Strain Gauge | Other | We wish to determine the relationship between tibial bone strain (recorded from implanted tibial strain gauges) and measured displacements of the limb and pelvis (using video motion analysis) during vibration exercise and a range of habitual locomotor activities. Only healthy volunteers will be recruited to this one arm. Receives: Device: Strain Gauge; Other: Vibration therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum amplitudes of the vibrating principal strain, and maximum shear strain, γv (microstrain) of the tibial bone calculated from the tibial bone strains recorded during vibration therapy
Measured: At time of Vibration Therapy
Maximum principal strain εh and maximum shear strain γh (microstrain) of the tibial bone calculated from the tibial bone strains recorded during habitual locomotor activities
Measured: At time of Vibration Therapy
Secondary outcomes (3)
Peak amplitude attenuation αv (in cm and percentage) and phase shift βv (in degrees) of the tibial strain primary endpoints εv and γv as a function of vibration frequency and amplitude (using the vibration device as a reference)
Measured: At time of Vibration Therapy
Peak amplitude attenuation and phase shift of the oscillating positional coordinates and accelerations
Peak amplitude attenuation αm (in cm and percentage) and phase shift βm (in degrees) of the oscillating positional coordinates and accelerations (at different anatomical landmarks) measured by VICON MX motion analysis system during vibration therapy (using the vibration device as a reference)
Measured: At time of Vibration Therapy
Posture during vibration therapy assessed in terms of the angulations of the ankle, knee and hip joints and of the trunk, derived from the positional coordinates
Measured: At time of Vibration Therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Eugene McCloskey, Professor, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430858
- Sponsor's protocol ID
- STH15516
- Status last verified
- Feb 2019
- First submitted
- 7 Sep 2011
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Induced Strains in the Human Tibia During Vibration Therapy and Habitual Activities
- ClinicalTrials.gov ID
- NCT01430858
- Acronym / sponsor ID
- STH15516
- Conditions
- Osteoporosis
- Keywords
- Fracture, Anabolic, Vibration, Strain Gauge, Focus - Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- Mar 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of this study is to test the hypothesis that vibration exercise can induce higher than normal bone strains and strain rates than are experienced during habitual locomotor activities.
The investigators plan to study healthy young volunteers to:
- Determine the relationship between tibial bone strain and
- the frequency and amplitude of vibration therapy
- a range of habitual locomotor activities;
- Determine the transmission of vibrations during vibration therapy, in terms of
- amplitude attenuation and phase shift of positional coordinates and accelerations at anatomic landmarks along the lower leg and other skeletal sites
- the relationship between these and different frequencies and amplitudes of vibration therapy;
- Determine the muscle power in the lower limb associated with various habitual locomotor activities and its relationship to the measured tibial bone strain.
The investigators subsequently hope to use the data captured in this experiment to develop a QCT-based finite element (FE) model of the human lower limb (tibia, fibula and foot). The investigators will then validate this model in relation to the characteristics (amplitude and phase shift) of the measured tibial bone strain and transmission of vibrations to the different anatomical landmarks during vibration therapy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Strain Gauge | Other | Device: Strain Gauge, Other: Vibration therapyWe wish to determine the relationship between tibial bone strain (recorded from implanted tibial strain gauges) and measured displacements of the limb and pelvis (using video motion analysis) during vibration exercise and a range of habitual locomotor activities. Only healthy volunteers will be recruited to this one arm. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female volunteers, ages 18 to 50 years
- Generally healthy, as determined by review of medical history and physical exam
- Ambulatory
- Willing and physically able to undergo all study procedures
- BMD (measured by DXA) at the lumbar spine and hip within ± 2 SD of the young normal range
Key exclusion criteria (25 listed)
- Previous diagnosis of osteoporosis
- History of fracture of the spine, pelvis, leg or foot
- History of bone or joint disorders affecting the shoulders, spine, pelvis, legs or feet (e.g. arthritis, congenital hip dislocation, spinal spondylolisthesis)
- Ongoing conditions or diseases known to cause secondary osteoporosis
- Malabsorption syndromes (e.g. coeliac or Crohn's disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strain GaugeAlso: Rosette strain gauge (FRA-2-11 Tokyo Sokki Kenkyujo Co., Japan)The study participants will each undergo sterile surgical implantation of a tibial bone strain gauge in the right leg (dominance will recorded and determined by handedness). A single stacked, 45°, rosette strain gauge (FRA-2-11 Tokyo Sokki Kenkyujo Co., Japan) will be unilaterally bonded to the medial tibial cortex and carefully aligned with the long axis of the tibia. The gauge will be attached at the mid-shaft region, to determine the transmission of the vibrations through the bone and quantification of the microstructural effect. | Device | Strain Gauge |
| Vibration therapyAlso: Galileo 900 platform (Novotec Medical GmbH, Medical device CE0123), Juvent 1000 platform (CE-marked), Power Plate Pro5 (CE-marked)Galileo 900 platform. Study subjects will be asked to stand on the device for a series of 36 tests, with vibrations applied at various frequencies and amplitudes. A 20-second duration of videomotion \& strain gauge readings will be captured. Juvent 1000 platform The volunteers will stand on the platform for one minute during which a 20-second duration of videomotion \& strain gauge readings will be captured. Power Plate Pro5 Two amplitude settings will be tested, described as low \& high. The subject will stand on each platform test for up to 1 minute, during which a 20-second duration of videomotion \& strain gauge readings will be captured. | Other | Strain Gauge |
Primary outcome
Maximum amplitudes of the vibrating principal strain, and maximum shear strain, γv (microstrain) of the tibial bone calculated from the tibial bone strains recorded during vibration therapy
Time frame: At time of Vibration Therapy
Maximum principal strain εh and maximum shear strain γh (microstrain) of the tibial bone calculated from the tibial bone strains recorded during habitual locomotor activities
Time frame: At time of Vibration Therapy
3 secondary outcomes
Peak amplitude attenuation αv (in cm and percentage) and phase shift βv (in degrees) of the tibial strain primary endpoints εv and γv as a function of vibration frequency and amplitude (using the vibration device as a reference)
Time frame: At time of Vibration Therapy
Peak amplitude attenuation and phase shift of the oscillating positional coordinates and accelerations
Time frame: At time of Vibration Therapy
Posture during vibration therapy assessed in terms of the angulations of the ankle, knee and hip joints and of the trunk, derived from the positional coordinates
Time frame: At time of Vibration Therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene McCloskey, Professor principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strain Gauge and Vibration therapy in people with Osteoporosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum amplitudes of the vibrating principal strain, and maximum shear strain, γv (microstrain) of the tibial bone calculated from the tibial bone strains recorded during vibration therapy (time frame: At time of Vibration Therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019; AzTrials last refreshed its copy on 28 Oct 2026.