National University of Health Sciences has received a $406K grant from Foot Levelers, Inc., to conduct a three-year study on the use of shoe orthotics for the treatment of chronic low back pain.
The university will begin enrolling 225 volunteer subjects who have chronic low back pain in this new, randomized, controlled clinical trial in March 2014. The subjects will be randomly split into three groups including: an orthotic treatment group, a chiropractic plus orthotic treatment group, and a wait-list control group.
The study will track changes in the volunteers' perceived pain levels and functional health status after six weeks and 12 weeks of care. Additionally, the study will assess long-term benefits of care by collecting the same measures at three, six, and 12 months following care.
"We are grateful to Foot Levelers for this generous grant," said Dr. Gregory Cramer, dean of research at NUHS. "There is a great need for research into conservative care for back pain, especially modalities that have the potential to reduce the need for pharmaceutical or surgical intervention."
The new grant follows a previous one-year pilot study that found a correlation between use of shoe orthotics and relief of low back pain. The previous NUHS study, also funded by Foot Levelers through a $50K grant, enrolled only 50 subjects. The results were significant, but not considered conclusive with such a small number of study participants.
The principal investigator on the new project is Jerrilyn Cambron, DC, MPH, PhD, a professor in the NUHS research department.
"Approximately 85% of the U.S. population will experience back pain at some point in their life, " said Dr. Cambron. "Our university is in a unique position to provide clinical research on non-surgical methods that may improve people's health and quality of life."
Added Dr. Manuel Duarte, chair of clinical practice at NUHS and an investigator on the project: "While there is certainly anecdotal evidence that the use of orthotics can reduce back pain, we are excited to do a broader study to document whether there is statistically relevant evidence to support the use of orthotics in patients with chronic low back pain."
Dr. Cambron and Dr. Duarte will be joined by Jennifer Dexheimer, BS, LMT, who is clinical coordinator for the project, and the university's expert in managing clinical trials.
NUHS has a long history in generating original research in basic and clinical sciences. It has received over $6.5 million in external and federal grants for research and remains in the upper tier of complementary and alternative medical (CAM) institutions in the research field.
For more information on research at National University of Health Sciences, visit www.nuhs.edu/research.
Source: National University of Health Sciences
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