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Effect of Radius on Alpha Motor Neuron Excitability (ERAMNE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00961870
First Posted: August 19, 2009
Last Update Posted: August 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ILHAN KARACAN, Vakif Gureba Training and Research Hospital
  Purpose

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.


Condition Intervention
Osteoporosis Procedure: Forearm vibration

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Radius Subjecting to Mechanical Loading on Alpha Motor Neuron Excitability

Resource links provided by NLM:


Further study details as provided by ILHAN KARACAN, Vakif Gureba Training and Research Hospital:

Primary Outcome Measures:
  • Changing alpha motor neuron excitability [ Time Frame: 1-2 months ]

Enrollment: 80
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy postmenopausal women
Forearm vibration will be applied in women without postmenopausal osteoporosis
Procedure: Forearm vibration
Mechanical loading with forearm vibration will be applied right radius in all groups.
Other Name: Cyclic mechanical loading
Experimental: Osteoporotic postmenopausal women
Forearm vibration will be applied in women with postmenopausal osteoporosis
Procedure: Forearm vibration
Mechanical loading with forearm vibration will be applied right radius in all groups.
Other Name: Cyclic mechanical loading
Experimental: Healthy young adult women
Forearm vibration will be applied in healthy young adult women
Procedure: Forearm vibration
Mechanical loading with forearm vibration will be applied right radius in all groups.
Other Name: Cyclic mechanical loading
Experimental: Healthy young adult men
Forearm vibration will be applied in healthy young adult men
Procedure: Forearm vibration
Mechanical loading with forearm vibration will be applied right radius in all groups.
Other Name: Cyclic mechanical loading

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00961870


Locations
Turkey
Vakif Gureba Training & Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Vakif Gureba Training and Research Hospital
Investigators
Study Chair: ILHAN KARACAN, MD Vakif Gureba Training & Research Hospital
  More Information

Responsible Party: ILHAN KARACAN, Vakif Gureba Training and Research Hospital
ClinicalTrials.gov Identifier: NCT00961870     History of Changes
Other Study ID Numbers: VGEAH FTR-2
First Submitted: August 14, 2009
First Posted: August 19, 2009
Last Update Posted: August 13, 2013
Last Verified: August 2013

Keywords provided by ILHAN KARACAN, Vakif Gureba Training and Research Hospital:
bone
motor neuron excitability
forearm vibration
Mechanical Loading

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases