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

Not Applicable

Completed

• Conditions: Osteoporosis
• Interventions: Device: Strain Gauge; Other: Vibration therapy

• Registration Number: NCT01430858
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

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:

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-09-07
• Study First Submitted QC: 2011-09-07
• Study First Posted: 2011-09-08
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Strain Gauge	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.
Strain Gauge	Vibration therapy	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.

Primary Outcome Measures

Name	Time	Method
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	At time of 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	At time of Vibration Therapy

Secondary Outcome Measures

Name	Time	Method
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)	At time of Vibration Therapy
Peak amplitude attenuation and phase shift of the oscillating positional coordinates and accelerations	At time of Vibration Therapy	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	At time of Vibration Therapy

Trial Locations

Locations (1)

Academic Unit of Bone Metabolism; 🇬🇧 Sheffield, South Yorks, United Kingdom