Chronic Low Back Pain Clinical Trial
Official title:
Orthotic Use for Chronic Low Back Pain: A Randomized Controlled Trial
The goal of this randomized clinical study is to assess pain and dysfunction in 225
volunteer subjects who have chronic low back pain.
The hypothesis of this study is that custom-made shoe will improve patients' low back pain
and dysfunction. Additionally, custom-made shoe orthotics plus chiropractic treatment will
further improve patients' low back pain and dysfunction while maintaining that improvement
during the one year study follow-up period.
Specific Aims:
1. To determine the changes in perceived pain levels (Numeric Pain Rating Scale) and
dysfunction (Oswestry Disability Index) in patients with chronic low back pain after
six weeks of custom-made shoe orthotic use with or without chiropractic care as
compared to no care.
2. To determine the changes in perceived pain levels and dysfunction in patients with
chronic low back pain after twelve weeks of custom-made shoe orthotic use.
3. To determine the changes in perceived pain levels and dysfunction at 3, 6, and 12
months following the 12 week treatment period.
n/a
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