Effect of Custom Foot Orthoses in Patients With Psoriatic Arthritis

NCT05075343 | Completed DMC

• 1 other identifier: 2020-3182
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Psoriatic Arthritis; Foot Arthritis

Outcome Measures

Primary Outcomes (1)

• Foot function

  Foot function was measure using the Foot function index (FFI). The FFI is a self-reported questionnaire composed of 23 items divided into three subscales measuring foot pain (FFI-P), foot disability (FFI-D) and foot-related activity limitation (FFI-AL). Each item of The FFI was recorded on a NRS (0 to 10) allowing for the calculation of both, total and subscale scores. The values range between 0 and 100, with higher values indicating greater pain, disability, and activity limitation.

  up to 12 weeks

Secondary Outcomes (5)

• Foot pain

  up to 12 weeks

• Orthoses wearing time

  7 weeks

• Global and lower limb pain

  up to 12 weeks

• Gait function

  up to 12 weeks

• Freeliving walking activities

  up to 12 weeks

Other Outcomes (1)

• Control variables

  7 weeks

Study Arms (1)

Custom foot orthoses (CFO)

EXPERIMENTAL

Participants with a confirmed diagnosis of PsA and foot pain received and wore custom foot orthoses (CFO).

Device: Custom foot orthoses

Interventions

Custom foot orthoses DEVICE

3D printed custom foot orthoses (CFO) were designed by the same experimented podiatrist based on a detailed clinical and biomechanical examination and a 3D foot scan obtained for each participant. The degrees and types were adjusted at the CFO delivery according to each patient's comfort and tolerance. The intervention period was 7weeks. The participants were taught to wear the CFO progressively during the first two weeks to allow for the lower limbs' muscles and structures to adjust to the CFO, and to wear the orthoses for the next 5 weeks, 7 days a week as often as they could.

Custom foot orthoses (CFO)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Patrick Boissy: lead

Study Sites (2)

Centre de recherche sur le vieillissement

Sherbrooke, Quebec, J1H 4C4, Canada

Location

Université de Sherbrooke

Sherbrooke, Quebec, J1H 4C4, Canada

Location

Related Publications (2)

• Walha R, Dagenais P, Gaudreault N, Beaudoin-Cote G, Boissy P. 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. Arthritis Res Ther. 2022 May 25;24(1):124. doi: 10.1186/s13075-022-02808-8.

  PMID: 35614481 DERIVED

• Walha R, Gaudreault N, Dagenais P, Boissy P. Spatiotemporal parameters and gait variability in people with psoriatic arthritis (PsA): a cross-sectional study. J Foot Ankle Res. 2022 Mar 4;15(1):19. doi: 10.1186/s13047-022-00521-y.

  PMID: 35246222 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Patrick Boissy, PhD

  Université de Sherbrooke

  STUDY DIRECTOR

• Nathaly Gaudreault, Phd

  Université de Sherbrooke

  STUDY DIRECTOR

• Pierre Dagenais, PhD

  Université de Sherbrooke

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 12, 2021
• Study Start: July 1, 2019
• Primary Completion: August 20, 2021
• Study Completion: August 20, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)