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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015113025308N1

Enrollment

Registered

2016-01-05

Start date

2015-12-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low back pain. Low back pain

Interventions

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. Instruc

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

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

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
Foot pain. Timepoint: at first visit, then every 4 weeks. Method of measurement: Question of subjects.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Mirshahi, MD

Sina Specialized & Subspecialty Hospital

m-mirshahi@razi.tums.ac.ir ; m.mirshahi2000@yahoo.com+98 21 6634 8569

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026