Skip to content

Efficacy of Customized and Prefabricated Foot Orthoses in Plantar Fasciitis.

Efficacy of Customized and Prefabricated Foot Orthoses in Plantar Fascitis: a Double-Blind Randomized Clinical Trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000319471
Enrollment
90
Registered
2007-06-18
Start date
2004-05-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Background: Foot orthoses are a modality of treatment frequently used mainly to relieve the pain caused by plantar fasciitis. This randomized trial evaluated the effectiveness of prefabricated and customized foot orthoses made in ethylene vinyl acetate (EVA), a cheap raw material not commonly cited in previous trials. Methods: A double-blinded, randomized trial was conducted from May 2004 to July 2005. Each participant was reviewed at four and eight weeks after the initial appointment. One hundred and forty-two patients were randomly allocated to receive a prefabricated or a customized foot orthosis, both made in EVA. The primary and secondary outcomes were pain, both measured by a visual analog scale and the previous was measured by the pain sub-scale of the Foot Function Index (FFI-pain) and later by palpation in the medial calcaneal tuberosity.

Interventions

One hundred and forty-two patients were randomly allocated to wear a prefabricated (intervention group) or a control, for eight weeks, both made in EVA.

Sponsors

Paulo SS Beraldo
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

A confirmed diagnosis of plantar fasciitis, who had experienced symptoms for at least 1 week.

Exclusion criteria

Patients with history of malignancy, pregnancy, inflammatory arthritis.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026