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Effect of Custom Foot Orthoses in Patients With Psoriatic Arthritis

P

Patrick Boissy

Status

Completed

Conditions

Foot Arthritis
Psoriatic Arthritis

Treatments

Device: Custom foot orthoses

Study type

Interventional

Funder types

Other

Identifiers

NCT05075343
2020-3182

Details and patient eligibility

About

Foot involvement is a major concern in psoriatic arthritis (PsA). The patients could experience severe levels of foot pain and disability and reduced mobility and quality of life. Previous studies showed that the use of Custom foot orthoses (CFO) was effective to improve foot pain and perceived disability in patients with foot disease associated with rheumatoid arthritis. However, there are no records in the literature on the effectiveness of CFO in PsA patients. Therefore, our objective was o explore the effects of CFO on foot pain, foot function, gait spatiotemporal parameters (STP), and ambulatory physical activity (APA) in PsA patients with foot involvement.

In this pre-experimental exploratory study, 22 PsA patients having stable medication in the last 3 months preceding the recruitment were recruited. All the patients wore functional CFO designed by an experimented podiatrist during a 7-week period. Foot and lower limb pain and foot function were measured at baseline (T0) and after the 7-week period using the numerical rating scale (NRS) and the foot function index (FFI), respectively. Gait function was assessed by recording spatiotemporal parameters (STPs) during a 10-meter walk test using an instrumented gait analysis system (Mobility Lab) at T0 and T7. Freeliving walking activities (step count, freeliving cadence, time spent in different ambulatory physical activity (APA) intensities) at T0 and T7 were recorded over 7 days using accelerometer data collected from an instrumented sock worn by the participants during waking hours.

Enrollment

22 patients

Sex

All

Ages

20 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Aged between 20 and 70 years
  • Diagnosed with psoriatic arthritis by a rheumatologist
  • Having moderate to severe foot pain scored at least 3 on the numeric rating scale
  • Having stable medication for the three months preceding the study

Exclusion criteria

  • Having diabetes or neurological disease that may affect the feet
  • Having recent traumatic foot injury
  • Having received specific interventions for the feet (ex: foot orthoses, orthopedic shoes, intraarticular steroid injection) for the three months preceding the study.
  • Having a recent history of foot surgery.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 1 patient group

Custom foot orthoses (CFO)
Experimental group
Description:
Participants with a confirmed diagnosis of PsA and foot pain received and wore custom foot orthoses (CFO).
Treatment:
Device: Custom foot orthoses

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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