The research article, “Shoe
Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled
Trial”, is a research study conducted by J. Cambron and her associates at the
National University of Health Sciences. This research investigated the
efficiency of shoe orthotics (with or without chiropractic care) as a treatment
for low back pain. The study design consisted of 225 participants divided into
3 groups, a waitlist group, foot levelers shoe orthotic group and a plus group.
The waitlist group acted as a control for the experiment, foot levelers were
given 2 orthotics, and the plus group was given orthotics plus chiropractic
In general, this is an appropriate study
design, by using 225 patients in total, this allows for a proper evaluation of
the effects of the intervention on a large scale. The large scale approach
provides the researchers with more data to evaluate and analyze. Additionally,
the participants were randomized into their respective groups by a research
fellow that was not involved in the study. This type of randomization maintains
a bias avoidance during the patient-intervention interaction.
Statistics of this study
mainly covered the following; baseline characteristics, changes in NPRS, and
changes in ODI. No evidence of significant differences we
found across treatments for any of the baseline characteristics. Statistics of
this study are appropriate for this study design by allowing for the clarification
of what the researchers seek to observe.
The outcome measures
for the research study were measured at 6 weeks, 12 weeks then an additional
3,6 & 12 months and included the following; LBP measured via a Numerical
Pain Rating Scale (NPRS) and Low back disability measure by Owestry Disability
Index (ODI). Researchers found that after 6 weeks, LBP and disability improved
for all 3 groups. There was a considerable improvement in foot levelers when
compared to the waitlist and the addition of chiropractic care demonstrated
when improvement in disability scores compared with the orthotics alone. At
week 12 and later, there were no significant changes in any of the groups. The
results were interpreted correctly, however the p-values for the changes that
occurred at week 6 (for the ODI) were less than 0.05, which suggest that the
results are not statistically significant.
Overall, this is a
well composed research study, the hypothesis makes logical sense and the
methodology is setup in such a way that it may accurately test the proposed
hypothesis. The results were analyzed and interpreted in a logical manner and
the figures presented contained the necessary data to ensure efficiency
(p-values, confidence intervals, etc.) The only aspect of the protocol that can
be deemed inappropriate for the study is that the control was given an
intervention of orthotics after 6 weeks and the participants in the control
were not excluded if they received treatment outside of the study.
This article is highly
relevant to clinical practice and field of PT by contributing new information
to our knowledge base. PTs understand that foot positioning and orthotics can
contribute to regional interdependence by acting along the kinetic chain and
thus PTs play a key role in assessing the need for orthotics.