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Effect of Radius on Alpha Motor Neuron Excitability (ERAMNE)

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Forearm vibration
Sponsored by
Vakif Gureba Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteoporosis focused on measuring bone, motor neuron excitability, forearm vibration, Mechanical Loading

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vakif Gureba Training & Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Healthy postmenopausal women

Osteoporotic postmenopausal women

Healthy young adult women

Healthy young adult men

Arm Description

Forearm vibration will be applied in women without postmenopausal osteoporosis

Forearm vibration will be applied in women with postmenopausal osteoporosis

Forearm vibration will be applied in healthy young adult women

Forearm vibration will be applied in healthy young adult men

Outcomes

Primary Outcome Measures

Changing alpha motor neuron excitability

Secondary Outcome Measures

Full Information

First Posted
August 14, 2009
Last Updated
August 12, 2013
Sponsor
Vakif Gureba Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00961870
Brief Title
Effect of Radius on Alpha Motor Neuron Excitability
Acronym
ERAMNE
Official Title
Effect of Radius Subjecting to Mechanical Loading on Alpha Motor Neuron Excitability
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vakif Gureba Training and Research Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
bone, motor neuron excitability, forearm vibration, Mechanical Loading

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy postmenopausal women
Arm Type
Experimental
Arm Description
Forearm vibration will be applied in women without postmenopausal osteoporosis
Arm Title
Osteoporotic postmenopausal women
Arm Type
Experimental
Arm Description
Forearm vibration will be applied in women with postmenopausal osteoporosis
Arm Title
Healthy young adult women
Arm Type
Experimental
Arm Description
Forearm vibration will be applied in healthy young adult women
Arm Title
Healthy young adult men
Arm Type
Experimental
Arm Description
Forearm vibration will be applied in healthy young adult men
Intervention Type
Procedure
Intervention Name(s)
Forearm vibration
Other Intervention Name(s)
Cyclic mechanical loading
Intervention Description
Mechanical loading with forearm vibration will be applied right radius in all groups.
Primary Outcome Measure Information:
Title
Changing alpha motor neuron excitability
Time Frame
1-2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ILHAN KARACAN, MD
Organizational Affiliation
Vakif Gureba Training & Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Vakif Gureba Training & Research Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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Effect of Radius on Alpha Motor Neuron Excitability

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