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

This study has been completed.
Sponsor:
Collaborator:
Kessler Foundation
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00886145
First received: April 21, 2009
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention
Spinal Cord Injuries
Device: Mechanical Stimulation with the Vibration Plate

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Using Low-magnitude High Frequency Mechanical Stimulation of Bone in Persons With Subacute SCI

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • The main objective of this pilot study is to determine an effect of mechanical stimulation to reduce loss of bone mass and preserve bone architecture of the stimulated tibia. [ Time Frame: After 6 months of Mechanical Stimulation Vibration Plate ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: June 2009
Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1

The subjects will undergo mechanical intervention in the seated position, 5 sessions a week, each session lasting 20 minutes for 6 months. All footwear will be removed, but they may wear socks or be barefoot. Only the right leg will be vibrated and the left leg will serve as a control. The frequency and force of the vibrations will be approximately 35Hz and 0.3g.

In additional load of 50lbs will be added to both legs by using an extra wide strap equipped with bungee cords. The vibrations will only be applied to the right leg even though both legs will be loaded. Vibrations will be eliminated from the left leg using a bridge over the vibrating plate. In order to eliminate the height discrepancy between the sides caused by the addition of the bridge, a spacer will be placed between the foot and the vibrating plate on the stimulated side. Training sessions will be recorded directly on the vibrating plate and must achieve a compliance of 85%.

Device: Mechanical Stimulation with the Vibration Plate

All subjects will undergo mechanical intervention in the seated position 5 sessions a week, with each session lasting up to 20 minutes in duration for 6 months. Subject participation will involve seven visits to the laboratory. The baseline (BL) visit, subjects will receive instruction on the use of and receive the equipment needed for vibration plate therapy at home. Training sessions will be recorded directly on the vibrating plate and compliance will be assessed during the monthly visits.

Testing will be performed at BL, 1, 3 and 6 months will involve the following: Dual energy X-ray absorptiometry (DXA), Blood Samples, 24 hour Urine and Vitamin D and Calcium Administration. Peripheral Quantitative Computed Tomography (pQCT) will be assessed only at BL and 6 months.

Other Name: MSVP

Detailed Description:

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:

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males;
  2. Age 18-65;
  3. Non-ambulatory SCI, with ASIA level A or B (ASIA A or B at the time of enrollment);
  4. Neurological level of injury C3-T10;
  5. 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:

  1. Osteoporosis or low bone mass as determined by medical history or DXA at the baseline visit;
  2. Pressure ulcer that may be exacerbated by the experimental procedure;
  3. Fracture of the lower extremity within the past 5 years;
  4. Active heterotopic ossification (HO);
  5. History of metabolic bone disease;
  6. Knee replacement(s);
  7. Metal hardware in the lower extremities;
  8. Bisphosphonate administration;
  9. Severe underlying chronic illness (cardiac, pulmonary, gastrointestinal, etc.);
  10. Renal disease (creatinine clearance < 40 mL/min);
  11. 25(OH)D levels <30ng/ml;
  12. Endocrine disorders known to be associated with osteoporosis (hyperthyroidism, hypercortisolism, and/or hypogonadism);
  13. Alcoholism;
  14. Seizure disorders;
  15. History of kidney stones; and
  16. Compliance 85% for every month up to the 4-month time-point
  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: NCT00886145

Locations
United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
Kessler Foundation
Investigators
Principal Investigator: William Bauman, MD VA Medical Center, Bronx
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00886145     History of Changes
Other Study ID Numbers: B4162C-10
Study First Received: April 21, 2009
Last Updated: April 25, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Spinal Cord Injuries
Mechanical Stimulation
Vibration Plate

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014