The hypothesis of this study is that since osteoarthritis of the knee is primarily a bone disease where the joint changes are secondary, and bone growth stimulators function to decrease intraosseous venous congestion and remodel bone, then there is a potential benefit for the treatment of osteoarthritis of the knee with bone growth stimulators.
The hypothesis of this study is based on the knowledge that osteoarthritis of the knee is primarily a bone disease, and the joint changes are secondary. Bone growth stimulators function to alleviate intraosseous venous congestion through the process of bone remodeling. The working hypothesis is that alleviation of intraosseous venous congestion leads to improved delivery of nutrition to the tissue to support the health of the bone with improvement in biomechanics leading to clinical improvement. Venous congestion is measured with intraosseous pressure. Additional objective evidence of biomarkers of bone metabolism as well as measurements of subjective questionnaires can provide evidence of benefit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Active device emits ultrasound signals.
Coastal Carolinas Integrated Medicine
Supply, North Carolina, United States
Intraosseous Venous Congestion measured by Intraossous Pressure.
Statistically significant decrease in intraosseous pressure following treatment.
Time frame: 14 weeks
Human Matrix Metalloproteinase-3 (MMP-3)
Statistically significant decrease in the biomarker MMP-3
Time frame: 14 weeks
C- telopeptide.
Statistically significant decrease in the biomarker C- telopeptide.
Time frame: 14 weeks
Change over time in WOMAC score.
The primary outcome variables are a statistically significant improvement in Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores.
Time frame: 14 weeks
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