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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886145
• Other study ID #: B4162C-10
• Status: Completed
• Phase: N/A
• First received: April 21, 2009
• Last updated: March 30, 2015
• Start date: June 2009
• Est. completion date: December 2012

Study information

• Verified date: March 2015
• Source: James J. Peters Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	VA Medical Center, Bronx	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
William A. Bauman, M.D.	Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		After 6 months of Mechanical Stimulation Vibration Plate	No