Effect of Radius on Alpha Motor Neuron Excitability (ERAMNE)

August 12, 2013 updated by: ILHAN KARACAN, Vakif Gureba Training and Research Hospital

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Vakif Gureba Training & Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Cyclic mechanical loading

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changing alpha motor neuron excitability
Time Frame: 1-2 months
1-2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vakif Gureba Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

November 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

August 14, 2009

First Submitted That Met QC Criteria

August 17, 2009

First Posted (ESTIMATE)

August 19, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 13, 2013

Last Update Submitted That Met QC Criteria

August 12, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGEAH FTR-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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