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Functional foot orthoses effectiveness in patients with Rheumatoid Arthritis

Functional foot orthoses vs placebo: Effectiveness in reducing pain and disability in patients with Rheumatoid Arthritis

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000168459
Acronym
FORA
Enrollment
68
Registered
2016-02-10
Start date
2016-10-14
Completion date
2017-10-17
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

This study is a randomized controlled trial in patients with rheumatoid arthritis with feet pain, which aims to determine the effectiveness of the rheumatoid arthritis custom made insoles. It is hoped that information gathered from this project will help to contribute to the body of knowledge to an optimal podiatry treatment rheumatoid arthritis patients

Interventions

Investigator M (podiatrist) will manufactured a pair of customized foot orthoses per participant asigned to the experimental group. A weight-bearing phenolic foam cast will be obtained previously from these participants. Foot orthoses will consist of 2 mm-thick polypropylene from heel to inmediately proximal to the metatarsal heads, a 5 mm-thick, 35-40 shore A, ethylene-vinyl superior sheet, personalized subdigital crest and rearfoot posting. Participants in experimental group will be encouraged

Investigator M (podiatrist) will manufactured a pair of customized foot orthoses per participant asigned to the experimental group. A weight-bearing phenolic foam cast will be obtained previously from these participants. Foot orthoses will consist of 2 mm-thick polypropylene from heel to inmediately proximal to the metatarsal heads, a 5 mm-thick, 35-40 shore A, ethylene-vinyl superior sheet, personalized subdigital crest and rearfoot posting. Participants in experimental group will be encouraged to wear these foot orthoses during 3 months, at least 8 hours a day, in a physiologic shoe (wide tip shoe and less than 4 cm heel). To monitor adherence to the intervention monthly reviews are scheduled.

Sponsors

University of Sevilla
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Patients with rheumatoid arthritis which is stable, and related foot alterations The participants are patients attending the Podiatric Clinical Area of the University of Sevilla.

Exclusion criteria

Pregnancy, patients with other inflamatory or neurologic diseases, patients with cognitive disorders who do not understand the questionnaries, patients with peripheral neuropathy or peripheral vascular disease, active rheumatoid arthritis, open skin wounds.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026