Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Trial

Abstract Objectives To investigate the efficacy of shoe orthotics with and without chiropractic treatment for chronic low back pain as compared to no treatment. Design Randomized Controlled Trial Setting An integrative medicine teaching clinic at a Midwestern university. Participants Two hundred and twenty-five adult subjects with symptomatic low back pain of 3 months or longer were recruited from a volunteer sample. Interventions Subjects were randomized into one of three treatment groups (Orthotics, Plus, and Wait-list Groups). The Orthotics Group received custom-made shoe orthotics The Plus Group received custom-made orthotics plus chiropractic manipulation, hot or cold packs, and manual soft tissue massage. The Wait-list Group received no care. Main Outcome Measures The primary outcome measures were change in perceived back pain (Numeric Pain Rating Scale) and functional health status (Oswestry) after 6 weeks of study participation. Outcomes were also assessed after 12 weeks and then after an additional 3, 6, and 12 months. Results After six weeks, all three groups demonstrated significant within-group improvement in average back pain, but only the Orthotics and Plus Groups had significant within-group improvement in function. When compared to the Wait-list Group, the Orthotics Group demonstrated significantly greater improvements in pain (p