Marodyne Clinical Research

Marodyne basic, applied, and clinical research using LIV (low intensity vibration) mechanical signals as a non-invasive, non-pharmacological method to regulate critical stem cell processes central to the regeneration of tissues, such as bone, is lead by Dr. Clinton Rubin. Currently LIV devices are being used in clinical trials (IRB approved) in the following areas :

  • improve/maintain bone quantity and quality of the weightbearing skeleton of elderly men and women
  • improve/maintain muscle mass and strength of the weightbearing skeleton of elderly men and women
  • improve/retain postural stability, as indicative of reducing risk of falls of elderly men and women
  • reduce risk of bone fracture in children with disabling conditions
  • reduce risk of bone fracture in young adults with spinal cord injury
  • suppress loss of bone in children with Crohn's disease
  • suppress loss of bone in adults with renal osteodystrophy
  • accelerate/augment the healing of distraction osteogenesis procedures
  • suppress loss of bone in children undergoing chemotherapy
  • enhancement of bone metabolic activity in young women with anorexia

For a complete listing of research findings see our Foundation of Marodyne section. Below are summarized featured clinical studies published in the prestigious peer reviewed journal, Journal of Bone & Mineral Research.

Prevention of Osteoporosis in Post-Menopausal Women


This study, performed using the Low Magnitude Mechanical Signals of the LIV technology in collaboration with R. Recker and D. Raab-Cullen at Creighton University's Osteoporosis Center, studied sixty-two healthy women, 3-8 years past the menopause, who were randomized into in a double-blind, placebo controlled pilot study. 32 women underwent mechanical loading of the lower appendicular and axial skeleton for two ten-minute periods per day, through floor mounted devices that produced a 0.2g mechanical stimulus at 30Hz (TX). 32 women received placebo devices (PL) and underwent daily treatment for the same period of time. Evaluating those in the highest quartile of compliance (86% compliant), PL lost 2.13% in the femoral neck over the year, while TX was associated with a gain of 0.04%, reflecting a 2.17% relative benefit of treatment (p=0.06). Considering the interdependence of weight, the spine of lighter women (< 65 Kg) who were in the highest quartile of compliance exhibited a relative benefit of TX of 3.35% greater BMD over the year (p=0.009); and for the mean compliance group a 2.73% relative benefit in BMD was measured (p=0.02).

Prevention of Post-Menopausal Bone Loss by a Low Magnitude, High Frequency Mechanical Stimuli; A Clinical Trial Assessing Compliance, Efficacy And Safety.  J. Bone & Mineral Research. 19:343-35.  Rubin, C.T., Recker, R., Raab, D., Ryaby, J., McCabe, J. & McLeod, K.J. (2004)

 

Bone and Muscle Growth in Young Osteoporotic Women

This clinical study, performed using the Low Magnitude Mechanical Signals of the LIV technology in collaboration with Dr. V. Gilsanz at the Children's Hospital of Los Angeles, investigated the potential of this intervention to stimulate bone gain in young women w/ osteoporosis. Following one year of treatment in young women (16-21y) in the lowest quartile of bone density, these mechanical signals (0.3g, 30Hz, ten minutes per day) enhanced trabecular bone of the spine by 4%, cortical bone of the femur by 3%, and cross sectional area of spinal muscular by 5%, as compared to controls which showed no significant change from baseline, influencing risk factors for osteoporosis beyond simply bone mass.

Low level, high frequency mechanical signals enhance musculoskeletal development of young women with low bone density. J. Bone & Mineral Research 21:1464-1474. Gilsanz, V., Wren, T., Sanchez, M., Dorey, F., Judex, S. & Rubin, C.  (2006)

Increasing Bone Density in Children with Disabilities

This study, performed using the Low Magnitude Mechanical Signals of the LIV technology in collaboration with K. Ward, J. Adams and Z. Mughal at the University of Manchester, UK, examined twenty children with cerebral palsy (4-19y), who were randomized into treatment (0.3g, 90Hz, ten minutes per day) and placebo groups. Following 6-months, the volumetric trabecular bone mineral density of the tibiae in the placebo group lost 11.9% of BMD in the proximal tibia, while the treatment group gained 6.3%, representing a 17.7% “benefit” of treatment (p=0.0033).

PDFLow magnitude, high frequency loading therapy increases volumetric tibial bone mineral density in children with disabling conditions. 
Ward, K., Alsop, C., Brown, S., Caulton, J., Rubin, C., Adams, J. & Mughal, M. (2004. J. Bone & Mineral Research: 19:360-369