Efficacy of Foot Orthotics in Veterans With Chronic Lower Back Pain

Specific Aim 1: Utilizing a gold standard sham controlled randomized trial design, we will
evaluate the change in pain, back related disability and quality of life in Veterans with
CLBP who utilize either a custom foot orthotic or a sham orthotic.

As part of this aim the investigators will build on the teams strength of recruiting and
enrolling Veteran's with CLBP into a randomized trial. The investigators will collect
baseline pain and disability measures utilizing validated tools. Once the patients are
enrolled, utilizing the "gold standard" placebo controlled design the investigators will
randomize patients to receive either a custom foot orthotic or a sham orthotic. The Veterans
will then be assessed at 5, 12 and 24-weeks post baseline to evaluate differences in pain and
disability. Based on previous studies on the effectiveness of custom foot orthotics the
investigators hypothesize that that Veteran's who receive the custom orthotic will experience
less pain and disability as compared to those who receive the sham orthotics.

Specific Aim 2: To evaluate baseline characteristics of Veterans with CLBP predictive of
responsiveness to custom foot orthotics including age, BMI, psychosocial characteristics and
arch classification.

Focusing on the Veterans who receive the custom foot orthotic, the investigators next examine
the important characteristics that may predict those Veterans who are most likely to benefit
from wearing custom foot orthotics. Assessing potential confounders or facilitators of
effectiveness of the custom foot orthotic will allow the investigators to best describe
potential mechanisms of responsiveness. The investigators have chosen previously described
confounders to responsiveness to treatment of CLBP, specifically age, body mass index and
psychosocial characteristics. This methodology is particularly important in a sham controlled
trial to assess if effectiveness or lack of thereof, is a factor of the intervention or from
other confounding variables. The investigators have also chosen to evaluate the arch
classification based on the measurement of the Veterans arch; again this allows for specific
recommendations concerning use of this product. Based on previous studies on the
effectiveness of custom foot orthotics in addition to previous studies evaluating CLBP the
investigators hypothesize that those Veterans who are older, have a higher BMI and greater
fear avoidance belief scores will show less responsiveness to the custom foot orthotics as
compared to those younger Veterans who have a lower BMI and lower fear avoidance belief
scores. In addition based on previous biomechanical literature, the investigators feel that
those Veterans with a lower arch will show the greatest responsiveness to the custom foot
orthotic.

INCLUSION:

Ages 18-65 Lower back pain ≥ 3 months in duration Pain elicited upon deep palpation of the
lumbar erector spinae musculature Primary complaint of CLBP from L1 to Sacroiliac joint
inclusive. Ability/willingness to use orthotics in their shoes Numeric Pain Rating Scale
(NRPS) of ≥ 3

- 30 mm on the Visual Analogue Scale (VAS)

- 20% for the Modified Oswestry Disability Index (mODI)

EXCLUSION:

spinal surgery, spinal injections or injections in their feet within the past 6 months
Inability to use orthotics in shoes Custom foot orthotics within the past 12 months
Currently undergoing Chiropractic, Physical Therapy or Acupuncture treatment for their
chronic lower back pain.

evidence of cauda equina syndrome, spinal neoplasia or metastatic disease, destructive
joint pathology such as rheumatoid arthritis bowel/bladder dysfunction (associated with the
back pain) peripheral neuropathy or progressive lumbosacral radiculopathy, progressive
myelopathy or neurogenic claudication.

open workers compensation or no fault case.