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IRCT2015113025308N1 IRCT 2016-01-05 Deputy of Research, Tehran University of Medical Sciences The effect of custom-made foot orthoses on low back pain The effect of custom-made foot orthoses on pain and function in subjects with lower back pain and flatfoot 2015-12-22 anticipated 62 Complete https://irct.ir/trial/21192 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 Low back pain. Intervention 1: Control group: one pair prefabricated foot orthoses made with polyester adjusting in to the size of the foot and fitting it into the shoes without change base of the foot mold. Instructions were given to the patients for gradual wearing the foot orthoses to discomfort and after 2 weeks, at least, 8h/day. Intervention 2: Intervention group: one pair custom-made foot orthoses made with polypropylene from heel to just behind the metatarsal heads. Instructions were given to the participants for gradual wearing the foot orthoses to discomfort and after 2 weeks, at least, 8 h/day.

public Maryam Mirshahi, MD

Sina Hospital, Imam Khomeini Ave., Hassan Abad Sq.,Tehran, Iran

Tehran Iran (Islamic Republic of) +98 21 6634 8569 m-mirshahi@razi.tums.ac.ir ; m.mirshahi2000@yahoo.com Sina Specialized & Subspecialty Hospital scientific Maryam Mirshahi, MD

Sina Hospital, Imam Khomeini Ave., Hassan Abad Sq.,Tehran, Iran

Tehran Iran (Islamic Republic of) +98 21 6634 8569 m-mirshahi@razi.tums.ac.ir ; m.mirshahi2000@yahoo.com Sina Specialized & Subspecialty Hospital Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: subjects between 18-45 years old with pain between T12 and the S1 joints؛ presence of chronic non-specific low back pain for at least 6 weeks or recurrent low back pain for 3 month؛ Foot Posture Index (FPI-6) indicating at least +6 Exclusion criteria: any pathologic or non-mechanical low back pain؛ history of foot surgery, foot or lower extremity truma or other conditions that may affect the measurement of this study؛ previous use of orthoses؛ leg length discrepancy greater 5 mm؛ peripheral neuropathy due to disorders such as diabetes 18 years 45 years Both M54.5 Low back pain Other Other Control group: one pair prefabricated foot orthoses made with polyester adjusting in to the size of the foot and fitting it into the shoes without change base of the foot mold. Instructions were given to the patients for gradual wearing the foot orthoses to discomfort and after 2 weeks, at least, 8h/day. Intervention group: one pair custom-made foot orthoses made with polypropylene from heel to just behind the metatarsal heads. Instructions were given to the participants for gradual wearing the foot orthoses to discomfort and after 2 weeks, at least, 8 h/day. Level of pain. Timepoint: on the day of inclusion in the study, 6th week, 12th week, 24th week. Method of measurement: Visual Analoge Scale (VAS). Level of function. Timepoint: on the day of inclusion in the study, 6th week, 12th week, 24th week. Method of measurement: Oswestry Disability Index Questionnaire. Foot pain. Timepoint: at first visit, then every 4 weeks. Method of measurement: Question of subjects. Deputy of Research, Tehran University of Medical Sciences Approved 2015-11-25 Ethics Committee, Teharan University of Medical Sciences Tehran University of Medical Siences, Qods Aven., Keshavarz Blv., Tehran, Iran Tehran Iran (Islamic Republic of)