OsteoporosisERAMNENCT00961870
Effect of Radius on Alpha Motor Neuron Excitability
A study testing Forearm vibration in people with Osteoporosis, run by Vakif Gureba Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study hypothesize that radius subjecting to mechanical loading may affect excitability of alpha motor neuron innervating muscle, based on its bone mineral density. If this hypothesis is valid, it can be firstly suggested that the relationship between bone mineral density and muscle strength is bidirectional. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Forearm vibration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2009to Dec 2009
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- females with postmenopausal osteoporosis (forearm BMD: T score <-2.0)
- females without postmenopausal osteoporosis (forearm BMD: T score >-1.0)
- healthy young adult females (forearm BMD normal)
- healthy young adult males (forearm BMD normal)
- cases with right handed patients in all groups
Who cannot join
- secondary osteoporosis
- neuropathy (central or peripheral)
- myopathy
- systemic diseases (arthritis, endocrine-metabolic diseases, bone diseases)
- professional sportswoman/sportsman
- subjects doing regular sports activities
- tendinopathy
- amputee, endoprosthesis, metal implants
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Vakif Gureba Training & Research Hospital
Istanbul
About this study
Official title: Effect of Radius Subjecting to Mechanical Loading on Alpha Motor Neuron Excitability
This study hypothesize that radius subjecting to mechanical loading may affect excitability of alpha motor neuron innervating muscle, based on its bone mineral density. If this hypothesis is valid, it can be firstly suggested that the relationship between bone mineral density and muscle strength is bidirectional.
A total of 80 voluntaries are planned to include in this study.
Read more
After forearm vibration is applied, bone mineral density (BMD) and bone mineral content (BMC) will be measured in all cases. Alpha motor neuron excitability (H/M ratio, recruitment), background muscle activity will be evaluated by electromyography at pre-treatment, post-treatment and, during treatment in cases.
Forearm vibration will be applied by forearm vibration device (FAV). FAV with mechanical loading will apply forearm. Cases will sit on armchair. Two intervals of FAV will be applied at a frequency of 45 Hz. Each interval will consist of 60 second of FAV followed by rest.
The right radius BMD and BMC will be evaluated by bone densitometer (GE-LUNAR DPX PRO).
Motor unite potentials at rest, Hoffman reflex, F response, M response will be measured by electromyography at right flexor carpi radialis. Medtronic Keypoint Portable 2 channel electromyography and Neurotrac ETS device will be used.
Read the detailed description
It is usually reported that there is a parallelism between changes in the bone structure and function and the muscle structure and function. Sarcopenia is frequently observed in osteoporotic patients. Bone formation increases or bone resorption decreases with exercise.
To date, the effect of bone on the muscle activity is not investigated. One of the most important functions of bone bear mechanical loads include body weight. Bone must be strong enough to resist the mechanical loading. Mechanisms need to protect bone when bone is subject to excessive mechanical loading. These mechanisms may mainly focus on strengthening the bone and/or changing vectorial properties of mechanical loading applied bone.
The vectorial properties of mechanical loading applied bone may be controlled by muscle contractions. Bone contains wide mechanoreceptor net constructed by osteocytes. So,distribution of the mechanical loading on bone cross-sectional area is possible to perceive. It may be also possible that inappropriate distribution of mechanical loading on bone crosssectional area is optimized by muscle contractions. To get this regulation, there should be a mechanism that muscle activity is controlled by central nervous system based on mechanical loading distribution on bone cross-sectional area. We previously showed that bone can regulate muscle activity, based on its bone mineral density. According to this study result, it can be suggested there may exist a mechanism that bone sensing mechanical stimuli can send the signals to central nervous system and neuronally regulate muscle activity (bone myo-regulation reflex). (It is also well known that load-induced adaptive bone formation is neuronally regulated. Taken together, a general mechanism, bone reflex, may be defined that bone subjected to loading can neuronally regulate bone formation and muscle activity)
This study hypothesize that radius subjecting to mechanical loading may affect excitability of alpha motor neuron innervating muscle, based on its bone mineral density.
- Conditions
- Osteoporosis
- Being tested
- Forearm vibration
- Keywords
- bone, motor neuron excitability, forearm vibration, Mechanical Loading
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forearm vibrationProcedure or surgery
Also called Cyclic mechanical loading
Mechanical loading with forearm vibration will be applied right radius in all groups.
| Study group | Role | What they receive |
|---|---|---|
| Healthy postmenopausal women | Experimental | Forearm vibration will be applied in women without postmenopausal osteoporosis Receives: Procedure: Forearm vibration |
| Osteoporotic postmenopausal women | Experimental | Forearm vibration will be applied in women with postmenopausal osteoporosis Receives: Procedure: Forearm vibration |
| Healthy young adult women | Experimental | Forearm vibration will be applied in healthy young adult women Receives: Procedure: Forearm vibration |
| Healthy young adult men | Experimental | Forearm vibration will be applied in healthy young adult men Receives: Procedure: Forearm vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing alpha motor neuron excitability
Measured: 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2009
- Study completionDec 2009
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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vakif Gureba Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILHAN KARACAN, Vakif Gureba Training and Research Hospital
- Investigators
- ILHAN KARACAN, MD, Study chair, Vakif Gureba Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961870
- Sponsor's protocol ID
- VGEAH FTR-2
- Acronym
- ERAMNE
- Status last verified
- Aug 2013
- First submitted
- 14 Aug 2009
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Radius Subjecting to Mechanical Loading on Alpha Motor Neuron Excitability
- ClinicalTrials.gov ID
- NCT00961870
- Acronym / sponsor ID
- ERAMNE / VGEAH FTR-2
- Conditions
- Osteoporosis
- Keywords
- bone, motor neuron excitability, forearm vibration, Mechanical Loading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Vakif Gureba Training and Research HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 19 Aug 2009 (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.
This study hypothesize that radius subjecting to mechanical loading may affect excitability of alpha motor neuron innervating muscle, based on its bone mineral density. If this hypothesis is valid, it can be firstly suggested that the relationship between bone mineral density and muscle strength is bidirectional.
A total of 80 voluntaries are planned to include in this study.
After forearm vibration is applied, bone mineral density (BMD) and bone mineral content (BMC) will be measured in all cases. Alpha motor neuron excitability (H/M ratio, recruitment), background muscle activity will be evaluated by electromyography at pre-treatment, post-treatment and, during treatment in cases.
Forearm vibration will be applied by forearm vibration device (FAV). FAV with mechanical loading will apply forearm. Cases will sit on armchair. Two intervals of FAV will be applied at a frequency of 45 Hz. Each interval will consist of 60 second of FAV followed by rest.
The right radius BMD and BMC will be evaluated by bone densitometer (GE-LUNAR DPX PRO).
Motor unite potentials at rest, Hoffman reflex, F response, M response will be measured by electromyography at right flexor carpi radialis. Medtronic Keypoint Portable 2 channel electromyography and Neurotrac ETS device will be used.
Detailed description
It is usually reported that there is a parallelism between changes in the bone structure and function and the muscle structure and function. Sarcopenia is frequently observed in osteoporotic patients. Bone formation increases or bone resorption decreases with exercise.
To date, the effect of bone on the muscle activity is not investigated. One of the most important functions of bone bear mechanical loads include body weight. Bone must be strong enough to resist the mechanical loading. Mechanisms need to protect bone when bone is subject to excessive mechanical loading. These mechanisms may mainly focus on strengthening the bone and/or changing vectorial properties of mechanical loading applied bone.
The vectorial properties of mechanical loading applied bone may be controlled by muscle contractions. Bone contains wide mechanoreceptor net constructed by osteocytes. So,distribution of the mechanical loading on bone cross-sectional area is possible to perceive. It may be also possible that inappropriate distribution of mechanical loading on bone crosssectional area is optimized by muscle contractions. To get this regulation, there should be a mechanism that muscle activity is controlled by central nervous system based on mechanical loading distribution on bone cross-sectional area. We previously showed that bone can regulate muscle activity, based on its bone mineral density. According to this study result, it can be suggested there may exist a mechanism that bone sensing mechanical stimuli can send the signals to central nervous system and neuronally regulate muscle activity (bone myo-regulation reflex). (It is also well known that load-induced adaptive bone formation is neuronally regulated. Taken together, a general mechanism, bone reflex, may be defined that bone subjected to loading can neuronally regulate bone formation and muscle activity)
This study hypothesize that radius subjecting to mechanical loading may affect excitability of alpha motor neuron innervating muscle, based on its bone mineral density.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy postmenopausal women | Experimental | Procedure: Forearm vibrationForearm vibration will be applied in women without postmenopausal osteoporosis |
| Osteoporotic postmenopausal women | Experimental | Procedure: Forearm vibrationForearm vibration will be applied in women with postmenopausal osteoporosis |
| Healthy young adult women | Experimental | Procedure: Forearm vibrationForearm vibration will be applied in healthy young adult women |
| Healthy young adult men | Experimental | Procedure: Forearm vibrationForearm vibration will be applied in healthy young adult men |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- females with postmenopausal osteoporosis (forearm BMD: T score <-2.0)
- females without postmenopausal osteoporosis (forearm BMD: T score >-1.0)
- healthy young adult females (forearm BMD normal)
- healthy young adult males (forearm BMD normal)
- cases with right handed patients in all groups
Key exclusion criteria (8 listed)
- secondary osteoporosis
- neuropathy (central or peripheral)
- myopathy
- systemic diseases (arthritis, endocrine-metabolic diseases, bone diseases)
- professional sportswoman/sportsman
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 |
|---|---|---|
| Forearm vibrationAlso: Cyclic mechanical loadingMechanical loading with forearm vibration will be applied right radius in all groups. | Procedure or surgery | Healthy postmenopausal women, Healthy young adult men, Healthy young adult women, Osteoporotic postmenopausal women |
Primary outcome
Changing alpha motor neuron excitability
Time frame: 1-2 months
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 13 Aug 2013.
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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.
ILHAN KARACAN, MD study chair
Vakif Gureba Training & Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forearm vibration in people with Osteoporosis, run by Vakif Gureba Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 8 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 13 Aug 2013. 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 Turkey (Türkiye). 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?
Changing alpha motor neuron excitability (time frame: 1-2 months). 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 13 Aug 2013.