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Does Vibration Therapy Induce Higher Than Normal Bone Strains and Strain Rates Than Those Experienced During Habitual Daily Activities

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Strain Gauge
Vibration therapy
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteoporosis focused on measuring Fracture, Anabolic, Vibration, Strain Gauge, Focus - Osteoporosis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • Academic Unit of Bone Metabolism

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Strain Gauge

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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)
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)
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

Full Information

First Posted
September 7, 2011
Last Updated
February 12, 2019
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
University of Sheffield
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1. Study Identification

Unique Protocol Identification Number
NCT01430858
Brief Title
Does Vibration Therapy Induce Higher Than Normal Bone Strains and Strain Rates Than Those Experienced During Habitual Daily Activities
Official Title
Measurement of Induced Strains in the Human Tibia During Vibration Therapy and Habitual Activities
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
University of Sheffield

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Fracture, Anabolic, Vibration, Strain Gauge, Focus - Osteoporosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strain Gauge
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Strain Gauge
Other Intervention Name(s)
Rosette strain gauge (FRA-2-11 Tokyo Sokki Kenkyujo Co., Japan)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Vibration therapy
Other Intervention Name(s)
Galileo 900 platform (Novotec Medical GmbH, Medical device CE0123), Juvent 1000 platform (CE-marked), Power Plate Pro5 (CE-marked)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Peak amplitude attenuation and phase shift of the oscillating positional coordinates and accelerations
Description
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)
Time Frame
At time of Vibration Therapy
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene McCloskey, Professor
Organizational Affiliation
University of Sheffield
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Unit of Bone Metabolism
City
Sheffield
State/Province
South Yorks
ZIP/Postal Code
S5 7AU
Country
United Kingdom

12. IPD Sharing Statement

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