Walking the Path to Proof
RESEARCH REVIEW
K. Jeffrey Miller
DC, MBA
The latest edition of the medical journal, Archives of Physical Medicine and Rehabilitation, features a chiropractic study that offers the most conclusive evidence yet that foot orthotics, specifically Foot Levelers custom orthotics, help patients with chronic lower back pain and dysfunction.1
Researchers at the National University of Health Sciences (NUHS) in Lombard, Illinois, placed 225 subjects in thr ee study groups: the Foot Levelers Shoe Orthotic Group (orthotics only), the Plus Group (orthotics plus chiropractic care), and the Wait List Group (control group, no treatment) for the 6 week study. Note: the Wait List Group did receive care after the sixth week.
Pain and function were assessed using a numeric pain scale and the Oswestry Low Back Disability Questionnaire. Measurements were recorded initially and at the end of 6 weeks. Follow-up measurements were then obtained at 12 weeks and then at 3, 6, and 12 months.
Findings showed decreased pain in all three groups after 6 weeks. Reductions in pain were significant in the Wait List Group but to a smaller degree than the other groups. Orthotic application alone improved chronic lower back pain by 34.5 %. Orthotic application plus chiropractic care improved chronic lower back pain by 40.4 %.
Lower back function improved in all three groups after 6 weeks. Improvement was not deemed significant in the Wait List Group. Improvement of 18.5 % was reported with orthotic
application alone. Improvement of 32.3 % was reported with orthotic application plus chiropractic care.1 See Table 1.
The study was financed by Foot Levelers, Inc. for specific testing of their custom orthotics. It was a follow-up study for a pilot study, also performed at NUHS and published in The Journal ofManipulative and Physiological Therapeutics, 2011. The results of that study were significant enough to warrant further study.2 Table 1
Group Pain Function Wait List Significant improveImproved ment but lower than but not other groups significant Foot Levelers Shoe 34.5 % Improved 18.5 % Orthotics Only Improved Foot Levelers 40.4 % Improved 32.3 % Shoe Orthotics plus Improved Chiropractic Care
Foot Levelers, Inc. (FLI) has been a longtime supporter of chiropractic research. The company has provided tireless effort, time, and financial support for research within multiple chiropractic colleges, research organizations, and publishers/ publications.
The evidence here provides increased validation of FLI products and chiropractic in several ways.
The study helps support the original premise behind Foot Levelers custom orthotics. Early in his career, Dr. Monte Greenawalt noticed that patients he shared with local podiatrists would often experience exacerbation or slow healing of their spinal complaints when orthotics were utilized for their foot conditions.
He reasoned that if orthotics could make spinal conditions worse, then orthotics could also improve spinal conditions. Dr. Greenawalt began studying the relationship between the feet, lower extremities, and the spine (the kinetic chain) leading to the development of the first chiropractic based shoe orthotic.3
Thousands of chiropractors have utilized Foot Levelers products over the last 65 years. This study helps affirm the confidence these doctors have placed in FLI products and the positive results seen in hundreds of thousands of patients.
Results of the study show the effectiveness of FLI custom orthotics alone and their effectiveness in increasing the positive effects of chiropractic care.
The status of chiropractic research is reflected in the quality of the study. The study was well designed. It was also a successful long term effort in a difficult environment.
The patient population of a chiropractic college clinic can be transient. While the study was for 6 weeks, patients were tracked for over 12 months beyond the principle study period - a difficult task with a shifting patient population. Great time and effort was involved in recruiting, treating, and tracking patients over the course of the study, a period of over three years horn conception to publication.
Study investigators were Jerrilyn Cambron, DC, MPH, PhD; Jennifer M. Dexheimer, BS, LMT; Manual Duarte, DC, MSAc, DABCO, DACBSP; and Sally Freels, MS, PHD. Kudos are due for the four investigators and the additional NUHS clinicians, researchers, staff, interns, and patients who participated.
The journal publishing the study is another important factor. The Archives
^The status of chiropractic research is reflected in the quality of the study. The study was well designed.
of Physical Medicine and Rehabilitation, established in 1945, is the publication of the American Congress of Rehabilitation Medicine. By publishing this study, it is placing chiropractic care, a chiropractic clinical product, and chiropractic research in front of medical providers in a specialty that has a patient base similar to that of chiropractic. The journal has very strict publication guidelines. Studies with low quality design, methodology, relevance, and writing are not accepted.
In 2008, the journal was ranked 9th among the top 27 physical medicine and rehabilitation journals and 12th among the top 72 sports science journals.4 One ofthe bench marks for ranking journals is the number of their publications that are cited by other authors. Citations of Archives of Physical Medicine and Rehabilitation are high and have increased dramatically in recent years.
With publication in the field of physical medicine and rehabilitation, the topic and results are also brought before many medical physicians who practice pain management. These physicians prescribe opioids. Opioid overuse and addiction are currently health concerns nationwide. The statistics are staggering.
According to 2014 statistics on opioid use published by The Department of Health and Human Services, on an average day in the United States:5
• Over 650,000 opioid prescriptions are dispensed
• 3,900 people begin non-medical use of prescription opioids
• 580 people initiate heroin use
• 78 people die horn opioid related overdose
Statistics for opioid economic costs per year are also staggering:5
• 55 billion yearly in health and social costs related to prescription opioid use
• 2 0 billion yearly in emergency department and inpatient care for opioid poisoning
An important question here is, “How are these statistics related to the NUHS study?”
The answer: patients with chr onic low back pain are among the thousands in the U.S. treated each day with opioids.
A 2015 study of opioid use for chronic low back pain reported6
“Short term (4 months) treatment with opioids provides modest
relief of chronic low back pain, but only minimal improvement in function compared with placebo.
The study further stated6
“Although no long term randomized controlled trials have been done, cohort studies have shown that 6 to 12 months of opioid use is associated with a small decrease in pain and either very minimal improvement in, or worsening of, disability.”
Returning to the results of this study for a comparison:
• Foot Levelers Shoe Orthotics Only: 34.5 % improvement in pain, 18.5% improvement in function
• Foot Levelers Shoe Orthotics Plus Chiropractic Care: 40.4% improvement in pain, 32.35% improvement in function
Several optimistic aspects of the NUHS study have been reviewed here, but nothing is more telling of the importance of the study than this last comparison.
References:
1. Cambron, J. A., Dexheimer, J. M., Duarte, M. & Freels, S. Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Trial. Archives of Physical Medicine and Rehabilitation (2017). doi: 10.1016/j.aprnr. 2017.03.028
2. Cambron, J. A., Duarte, M., Dexheimer, J. & Solecki, T. Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Pilot Study. Journal of Manipulative and Physiological Therapeutics 34, 254-260 (2011).
3. Hyland, J. K. Spinal Pelvic Stabilization: A Practical Approach to Orthotic Application. (Foot Levelers, 2002).
4. Archives of Physical Medicine and Rehabilitation. Scimago Journal & Country Rank Available at: http:/ scimagojr.com/. (Accessed: 16th July 2017)
5. Secretary, H. H. S. O. & Assistant Secretary for Public Affairs (ASPA). Opioids: The Prescription Drug & Heroin Overdose Epidemic. HHS.gov (2016). Available at: https://www.hhs.gov/opioids. (Accessed: 16th July 2017)
6. Freund, J., Kraus, C. & Hooper-Lane, C. Clinical Inquiry: How effective are opioids for chronic low back pain? The Journal of Family Practice. (2015). Available at: https://www.ncbi.nlm.nih.gov/ pubmed/26546957. (Accessed: 16th July 2017)
K. Jeffrey Miller, DC, MBA, Chiropractic Orthopedist, Assistant Professor of Chiropractic, Departments of Orthopedic Surgery and Physical Medicine and Rehabilitation, Missouri Orthopedic Institute, University of Missouri Health Care, Columbia, Missouri.
