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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor:
Collaborator:
University of Sheffield
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01430858
First received: September 7, 2011
Last updated: December 14, 2012
Last verified: December 2012
  Purpose

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:

  1. Determine the relationship between tibial bone strain and

    • the frequency and amplitude of vibration therapy
    • a range of habitual locomotor activities;
  2. 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;
  3. 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.


Condition Intervention
Osteoporosis
Device: Strain Gauge
Other: Vibration therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Measurement of Induced Strains in the Human Tibia During Vibration Therapy and Habitual Activities

Resource links provided by NLM:


Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

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 [ Time Frame: At time of Vibration Therapy ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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) [ Time Frame: At time of Vibration Therapy ] [ Designated as safety issue: No ]
  • Peak amplitude attenuation and phase shift of the oscillating positional coordinates and accelerations [ Time Frame: At time of Vibration Therapy ] [ Designated as safety issue: No ]
    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 [ Time Frame: At time of Vibration Therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: March 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Strain Gauge
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.
Device: Strain Gauge
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.
Other Name: Rosette strain gauge (FRA-2-11 Tokyo Sokki Kenkyujo Co., Japan)
Other: Vibration therapy

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.

Other Names:
  • Galileo 900 platform (Novotec Medical GmbH, Medical device CE0123)
  • Juvent 1000 platform (CE-marked)
  • Power Plate Pro5 (CE-marked)

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430858

Contacts
Contact: Eugene McCloskey, Professor 0114 2714705 E.V.McCloskey@sheffield.ac.uk
Contact: Tracey S Higginbottom 01142715238 ext 15238 Tracey.Higginbottom@sth.nhs.uk

Locations
United Kingdom
Academic Unit of Bone Metabolism Recruiting
Sheffield, South Yorks, United Kingdom, S5 7AU
Contact: Eugene McCloskey, Professor    0114 2714705    e.v.mccloskey@sheffield.ac.uk   
Contact: Tracey S Higginbottom    01142715238 ext 15238    Tracey.Higginbottom@sth.nhs.uk   
Principal Investigator: Eugene McCloskey, Professor         
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield
Investigators
Principal Investigator: Eugene McCloskey, Professor University of Sheffield
  More Information

No publications provided

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01430858     History of Changes
Other Study ID Numbers: STH15516
Study First Received: September 7, 2011
Last Updated: December 14, 2012
Health Authority: UK: NRES

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Fracture
Anabolic
Vibration
Strain Gauge
Focus - Osteoporosis

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

ClinicalTrials.gov processed this record on September 22, 2014