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

• Sponsor: William A. Bauman, M.D. (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00886145
• Collaborator: Kessler Foundation (Other)
• Enrollment: 1
• Location: 1
• Arm: 1
• Duration (Months): 42
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries	Device: Vibration: Right Leg and No Vibration: Left Leg.	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effect of Using Low-magnitude High Frequency Mechanical Stimulation of Bone in Persons With Subacute SCI
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm

Intervention/Treatment

Other: Vibration and No Vibration Vibration: Right Leg and No Vibration: Left Leg.

Device: Vibration: Right Leg and No Vibration: Left Leg.; 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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	VA Medical Center, Bronx	Bronx	New York	United States	10468

Sponsors and Collaborators

• William A. Bauman, M.D.
• Kessler Foundation

Investigators

• Principal Investigator: William Bauman, MD, VA Medical Center, Bronx

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Spinal Cord Damage Research Center

Publications

None provided.

• Responsible Party: William A. Bauman, M.D., Director, James J. Peters Veterans Affairs Medical Center
• ClinicalTrials.gov Identifier: NCT00886145
• Other Study ID Numbers: B4162C-10
• First Posted: Apr 22, 2009
• Last Update Posted: Apr 28, 2016
• Last Verified: Feb 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by William A. Bauman, M.D., Director, James J. Peters Veterans Affairs Medical Center: Spinal Cord Injuries; Mechanical Stimulation; Vibration Plate
• Additional relevant MeSH terms: Spinal Cord Injuries

Study Results

Participant Flow

Arm/Group Title	Vibration: Right Leg and No Vibration: Left Leg
Arm/Group Description	The subjects will undergo vibration 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 35 Hz and 0.3 g. In additional load of 50lbs will be added to both legs by using an extra wide strap equipped with bungee cords.
Period Title: Overall Study
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Vibration- Right Leg and No Vibration-left Leg
Arm/Group Description	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. 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.
Overall Participants	1
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	1 100%

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at 6-Months
Description	Volumetric Bone Mineral Density of the Right and Left Distal Tibia as Determined by Peripheral Quantitative Computed Tomography
Time Frame	The Percent Change in vBMD from Baseline to 6 months after Mechanical Stimulation Vibration Therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vibration- Right Leg	No Vibration- Left Leg
Arm/Group Description	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.
Measure Participants	1	1
Number [Percent Change]	-11	-5.7

Adverse Events

Time Frame	1.5 years
Arm/Group Title	Vibration- Right Leg:		No Vibration-left Leg:
Arm/Group Description	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.
All Cause Mortality
	Vibration- Right Leg:		No Vibration-left Leg:
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Vibration- Right Leg:		No Vibration-left Leg:
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/1 (100%)		1/1 (100%)
Nervous system disorders
Autonomic Dysreflexia	1/1 (100%)	1	1/1 (100%)	1
Other (Not Including Serious) Adverse Events
	Vibration- Right Leg:		No Vibration-left Leg:
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)

Limitations/Caveats

Subject recruitment was untenable due to the physiological and psychological healing necessary during the sub-acute phase of spinal cord injury.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.