In plain terms: Custom Foot Orthotics has some human trial evidence supporting it, but the evidence is not yet strong enough for EBL to call it established. It is worth knowing about and worth discussing with your clinician.
Custom Foot Orthotics
The evidence as the record states it
Cambron et al. (Arch Phys Med Rehabil, 2017; PMID 28465224): 225 adults with low back pain for at least 3 months randomized to custom-made shoe orthotics, orthotics plus chiropractic care, or a waitlist. At 6 weeks the orthotic group improved more than waitlist on pain (numerical rating scale) and function (Oswestry Disability Index); differences at 12 weeks and later were not significant. The trial was funded by a grant from Foot Levelers. Castro-Méndez et al. (Prosthet Orthot Int, 2013; PMID 23327838): 51 adults with excessive foot pronation and chronic low back pain randomized, double-blind, to custom-made orthoses or placebo insoles; pain and disability fell at 4 weeks. Castro-Méndez et al. (Int J Environ Res Public Health, 2021; PMID 34201981): 101 adults with pronated feet and chronic low back pain randomized to custom orthoses or non-corrective insoles; pain and Oswestry scores fell at 4 weeks. Lin et al. (Disabil Rehabil, 2026; PMID 40844962): meta-analysis of 7 randomized trials (423 participants), foot orthoses reduced pain and disability versus controls, GRADE certainty low, preformed insoles not effective for pain. Grade B: replicated by independent groups, but on short-term self-reported outcomes.
Why Grade B and not Grade A
Grade B reflects moderate human evidence -- typically a single strong trial, multiple smaller trials, or surrogate endpoint data without hard clinical outcome replication. To reach Grade A, Custom Foot Orthotics would require at least one additional independent randomized trial demonstrating a hard clinical endpoint or objectively measured functional outcome in a comparable population.
What this grade covers and what it does not
What would move this grade
An independent randomized trial demonstrating a hard clinical endpoint -- mortality, major adverse event, or objectively confirmed functional improvement -- in an adequately powered sample, with results independently replicated, would support Grade A.
How this was studied
Form: Custom-made foot orthotics from a practitioner-taken impression or scan; placebo or non-corrective insoles as control in two trials, a waitlist in the largest · Dose: 1 pair worn daily in everyday shoes for 4 to 6 weeks before the primary outcome · Population: Adults with chronic low back pain (3 months or more); two trials enrolled only people with excessive foot pronation · Duration: 4 to 6 weeks to the primary outcome; follow-up to 12 months in the largest trial, where the effect had faded by 12 weeks · What is sold differs: Off-the-shelf insoles are sold for back pain as though they were the same thing. The meta-analysis found preformed insoles did not reduce pain; this grade describes custom orthotics only.