N/A
N=1
Effect of Vibration Therapy on Bone in Persons With Sub-acute Spinal Cord Injury
Spinal Cord Injuries
Bottom Line
View on ClinicalTrials.gov: NCT00886145 ↗Enrolled (actual)
1
Serious AEs
100.0%
Results posted
Apr 2016
Primary outcome: Primary: Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at 6-Months — -11; -5.7 Percent Change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vibration: Right Leg and No Vibration: Left Leg. (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- William A. Bauman, M.D.
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at 6-Months |
-11; -5.7 | — |
Summary
The purpose of this research study is to determine the effect of mechanical vibrations on bones of persons with spinal cord injury.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00886145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.