OBJECTIVES: The purpose of this pilot study was to investigate the feasibility of a randomized clinical trial of shoe orthotics for chronic low back pain. METHODS: The study recruited 50 patients with chronic low back pain through media advertising in a midwestern suburban area. Medical history and a low back examination were completed at a chiropractic clinic. Subjects were randomized to either a treatment group receiving custom-made shoe orthotics or a wait-list control group. After 6 weeks, the wait-list control group also received custom-made orthotics. This study measured change in perceived pain levels (Visual Analog Scale) and functional health status (Oswestry Disability Index) in patients with chronic low back pain at the end of 6 weeks oforthotic treatment compared with no treatment and at the end of 12 weeks of orthotic treatment. RESULTS: This study showed changes in back pain and disability with the use of shoe orthotics for 6 weeks compared with a wait-list control group. It appears that improvement was maintained through the 12-week visit, but the subjects did not continue to improve during this time. CONCLUSIONS: This pilot study showed that the measurement of shoe orthotics to reduce low back pain and discomfort after 6 weeks of use is feasible. A larger clinical trial is needed to verify these results.
RCT Entities:
OBJECTIVES: The purpose of this pilot study was to investigate the feasibility of a randomized clinical trial of shoe orthotics for chronic low back pain. METHODS: The study recruited 50 patients with chronic low back pain through media advertising in a midwestern suburban area. Medical history and a low back examination were completed at a chiropractic clinic. Subjects were randomized to either a treatment group receiving custom-made shoe orthotics or a wait-list control group. After 6 weeks, the wait-list control group also received custom-made orthotics. This study measured change in perceived pain levels (Visual Analog Scale) and functional health status (Oswestry Disability Index) in patients with chronic low back pain at the end of 6 weeks of orthotic treatment compared with no treatment and at the end of 12 weeks of orthotic treatment. RESULTS: This study showed changes in back pain and disability with the use of shoe orthotics for 6 weeks compared with a wait-list control group. It appears that improvement was maintained through the 12-week visit, but the subjects did not continue to improve during this time. CONCLUSIONS: This pilot study showed that the measurement of shoe orthotics to reduce low back pain and discomfort after 6 weeks of use is feasible. A larger clinical trial is needed to verify these results.
Authors: Hylton B Menz; Alyssa B Dufour; Jody L Riskowski; Howard J Hillstrom; Marian T Hannan Journal: Rheumatology (Oxford) Date: 2013-09-17 Impact factor: 7.580
Authors: Aurora Castro-Méndez; Inmaculada Concepción Palomo-Toucedo; Manuel Pabón-Carrasco; Javier Ramos-Ortega; Juan Antonio Díaz-Mancha; Lourdes María Fernández-Seguín Journal: Int J Environ Res Public Health Date: 2021-06-25 Impact factor: 3.390