Skip to main content
OpenTrials
Completed

NCT Number: NCT00886145

Effect of Vibration Therapy on Bone in Persons With Sub-acute Spinal Cord Injury

The purpose of this research study is to determine the effect of mechanical vibrations on bones of persons with spinal cord injury.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

About this study

One of the major complications in persons with spinal cord injury (SCI) is marked bone loss because it greatly predisposes to skeletal fractures, even after minimal trauma. The use of low magnitude mechanical stimulation has been shown to be both safe and effective in improving bone mass and strength in animal studies. This modality has also been shown a beneficial effect in children with disability and in postmenopausal women. The investigators are interested in obtaining data to determine the possible benefits that mechanical intervention with vibratory stimulation may have on bone in individuals with subacute SCI (e.g., >1 month after injury but <1 year). Changes in bone density and mass of the leg and arm will be determined by dual energy X-ray absorptiometry (DXA); bone architecture of the distal leg and distal arm will be determined by peripheral quantitative computed tomography; circulating metabolic markers of bone will also be performed.

OBJECTIVES

In persons with subacute spinal cord injury:

  • To determine differences in bone mineral mass and parameters of bone structural integrity of the stimulated tibia versus the unstimulated tibia.
  • To determine changes in the metabolic markers of bone resorption and formation in persons with subacute spinal cord injury.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males;
  • Age 18-65;
  • Non-ambulatory SCI, with ASIA level A or B (ASIA A or B at the time of enrollment);
  • Neurological level of injury C3-T10;
  • Duration of injury >1 month after injury but <1 year; and 6.25(OH)D levels 30ng/ml (patients with values <30ng/ml will be supplemented with vitamin D to normalize values prior to study participation).

Exclusion criteria

  • Osteoporosis or low bone mass as determined by medical history or DXA at the baseline visit;
  • Pressure ulcer that may be exacerbated by the experimental procedure;
  • Fracture of the lower extremity within the past 5 years;
  • Active heterotopic ossification (HO);
  • History of metabolic bone disease;
  • Knee replacement(s);
  • Metal hardware in the lower extremities;
  • Bisphosphonate administration;
  • Severe underlying chronic illness (cardiac, pulmonary, gastrointestinal, etc.);
  • Renal disease (creatinine clearance < 40 mL/min);
  • 25(OH)D levels <30ng/ml;
  • Endocrine disorders known to be associated with osteoporosis (hyperthyroidism, hypercortisolism, and/or hypogonadism);
  • Alcoholism;
  • Seizure disorders;
  • History of kidney stones; and
  • Compliance 85% for every month up to the 4-month time-point

Treatment and study plan

Vibration: Right Leg and No Vibration: Left Leg.

Device

Vibration- right leg: The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.

No Vibration-left leg: At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.

Primary outcomes

  1. Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at 6-Months

    Time frame: The Percent Change in vBMD from Baseline to 6 months after Mechanical Stimulation Vibration Therapy

    Volumetric Bone Mineral Density of the Right and Left Distal Tibia as Determined by Peripheral Quantitative Computed Tomography

Sponsors and collaborators

Lead sponsor

William A. Bauman, M.D.

Fed

Collaborators

  • Kessler Foundation

Registry information

Official study title

Effect of Using Low-magnitude High Frequency Mechanical Stimulation of Bone in Persons With Subacute SCI

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 22, 2009
Registry last updated
Apr 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.