A new study touted as "the first large-scale clinical trial assessing orthotics for treatment of LBP" suggests custom orthotics are an effective treatment option, alone or in combination with chiropractic care, for relieving pain and improving function in patients with chronic low back pain.1
Researchers randomized 225 adult subjects with symptomatic LBP for three months or more into three groups for comparison. Pain and disability were assessed at baseline and re-assessed after six weeks. The shoe orthotic group received custom-made orthotics; the "plus" group received custom orthotics plus chiropractic care (manipulation, hot or cold packs and manual soft-tissue massage); and the "waitlist" group received no intervention until week six of the study, at which time they also received custom orthotics.
After six weeks, shoe orthotic and "plus" patients had experienced significant improvements in pain and function compared to patients receiving no intervention until week six (waitlist group). Comparing the orthotics-only and "plus" groups, the latter achieved greater improvements in function, but similar pain relief as the orthotics-only group.
Perhaps most notably, decreased pain and functional improvement remained significant for up to 12 months in all three groups (even the waitlist group, which received orthotics only at week six), suggesting orthotic intervention, alone or in combination with chiropractic care, can have a lasting impact on chronic LBP. As the authors stated:
"It is noteworthy that for most time points after week 6, the MCID [minimal clinically important difference] data remained relatively stable, with no large decreases in the proportion of subjects who had at least 30% improvement in pain or disability compared with baseline, potentially demonstrating a lasting effect of care with the orthotic treatment."
Dr. Manuel Duarte, study co-investigator and chair of clinical practices at National University of Health Sciences, commented on the importance of the findings in a statement to DC:
"This study proves what doctors and patients have been recognizing for years: Custom-made orthotics, particularly orthotics that support all three arches and accommodate the entire gait cycle as utilized in this study, significantly help reduce chronic low back pain."
Editor's Note: This study has been classified as "gold open access," meaning readers can access the full text free of charge. Note that Foot Levelers funded this study and subjects in all three groups utilized custom orthotics.
Reference
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