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

Abstract

ObjectivesTo investigate the efficacy of shoe orthotics with and without chiropractic treatment for chronic low back pain compared with no treatment. DesignRandomized controlled trial. SettingIntegrative medicine teaching clinic at a university. ParticipantsAdult subjects (N=225) with symptomatic low back pain of ≥3 months were recruited from a volunteer sample. InterventionsSubjects were randomized into 1 of 3 treatment groups (shoe orthotic, plus, and waitlist groups). The shoe orthotic 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 waitlist group received no care. Main Outcome MeasuresThe primary outcome measures were change in perceived back pain (numerical pain rating scale) and functional health status (Oswestry Disability Index) after 6 weeks of study participation. Outcomes were also assessed after 12 weeks and then after an additional 3, 6, and 12 months. ResultsAfter 6 weeks, all 3 groups demonstrated significant within-group improvement in average back pain, but only the shoe orthotic and plus groups had significant within-group improvement in function. When compared with the waitlist group, the shoe orthotic group demonstrated significantly greater improvements in pain (P<.0001) and function (P=.0068). The addition of chiropractic to orthotics treatment demonstrated significantly greater improvements in function (P=.0278) when compared with orthotics alone, but no significant difference in pain (P=.3431). Group differences at 12 weeks and later were not significant. ConclusionsSix weeks of prescription shoe orthotics significantly improved back pain and dysfunction compared with no treatment. The addition of chiropractic care led to higher improvements in function.