OBJECTIVES: To investigate the efficacy of shoe orthotics with and without chiropractic treatment for chronic low back pain compared with no treatment. DESIGN: Randomized controlled trial. SETTING: Integrative medicine teaching clinic at a university. PARTICIPANTS: Adult subjects (N=225) with symptomatic low back pain of >/=3 months were recruited from a volunteer sample. INTERVENTIONS: Subjects 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 MEASURES: The 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. RESULTS: After 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. CONCLUSIONS: Six 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. CI - Copyright (c) 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.