The effects of custom-made foot orthoses on foot pain, foot function, gait function, and free-living walking activities in people with psoriatic arthritis (PsA): a pre-experimental trial

Abstract

Introduction: Foot involvement is a significant concern in psoriatic arthritis (PsA) as it can lead to severe levels of foot pain and disability and reduced mobility and quality of life. Previous studies have shown moderate efficacy for custom-made foot orthoses (CFO) in reducing foot pain and disability in people with rheumatoid arthritis. However, evidence on the efficacy of CFO in people with PsA is lacking.

Objectives: To explore the effects of CFO on foot function, foot and lower limb pain, gait function, and free-living walking activities (FWA) in people with PsA.

Methods: A pre-experimental study including twenty participants with PsA (mean age: 54.10 ± 9.06 years and disease duration: 11.53 ± 10.22 years) was carried out. All the participants received and wore CFO for 7 weeks. Foot and lower limb pain and foot function were measured before and after the intervention using the numerical rating scale (NRS) and the foot function index (FFI). Gait function was assessed by recording spatiotemporal parameters (STPs) during a 10-m walk test using an instrumented gait analysis system (Mobility Lab). Free-living walking activities (step count, free-living cadence, time spent in different ambulatory physical activities (APA)) were recorded over 7 days using an accelerometer-instrumented sock.

Results: The FFI reported scores demonstrated severe baseline levels of foot pain (54.46 ± 14.58 %) and disability (46.65 ± 16.14%). Statistically and clinically significant improvements in foot pain and foot function and large effect sizes (Cohen's effect size > 1, p < 0.005) were observed after the intervention period. A strong correlation (r = -0.64, p < 0.01) between the CFO wearing time and foot function was demonstrated. However, no significant changes were found for gait STP or free-living walking activities after 7 weeks of CFO use.

Conclusion: Results support the clinical and biomechanical plausibility of using CFO in people with PsA to reduce pain and improve foot function. Large-scale and controlled studies are needed to confirm these findings. Moreover, a multidisciplinary approach including the prescription of exercise therapy and physiotherapy combined with CFO could be required to improve STP and promote APA in people with PsA.

Trial registration: ClinicalTrials.gov , NCT05075343 . Retrospectively registered on September 29, 2021.

Keywords: Custom foot orthoses; Foot function; Foot pain; Free-living walking activities; Psoriatic arthritis; Spatiotemporal parameters.

Fig. 1

a Foot function and b global and lower limb pain pre- (baseline) and post-intervention period. *Significant differences (p values < 0.05) in mean values between baseline and final follow-up. FFI foot function index, NRS numerical rating scale, d Cohen’s effect size

Fig. 2

a Weekly CFO wearing time and b weekly foot pain intensity recorded in the patients’ diaries using the NRS

Fig. 3

Correlation between weekly CFO wearing time averaged for the last 5 weeks of the intervention period and the FFI subscales and the total score recorded at T7

Fig. 4

Step count. a Daily averaged steps and b number of steps of the different step-based active episode categories

Fig. 5

Free-living cadence. a Free-living daily averaged cadence and b cadence for the different step-based active event categories

Fig. 6

Time spent in APA intensity-based categories. a Total active time and time spent in stepping activities and b time spent in purposeful walking including only active events of more than 60 steps