NCT03561688

Brief Summary

The overall purpose of this project is to investigate the neuro adaptations of pain and biomechanical differences between placebo and a custom-made foot orthoses for patients with RA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 3, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

May 8, 2018

Last Update Submit

February 28, 2020

Conditions

Rheumatoid ArthritisRheumatoid Arthritis of Foot (Disorder)

Keywords

BiomechanicsPainGaitFoot orthoticsRheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Change in gait mechanics

    Gait analysis will be performed using a 3D marker-based motion capture system from Qualisys, Sweden. To investigate gait mechanics, detailed patient-specific musculoskeletal (MS) computer models will be created based on clinical medical images (MRI), anthropometrics and motion capture data. The models will be created utilizing a musculoskeletal computer modeling software AnyBody Modeling System (AMS). A detailed cadaver-based model The Twente Lower Extremity Model 2.0 (TLEM 2.0) is developed for AMS to obtain patient-specific architecture, scale bones, joints, and muscles attachments relative to the patient in combination with image-based morphing techniques. These models will be used to estimate joint angles, joint torques, muscle forces and joint forces of the ankle, knee and hip joint.

    Week 4 and 8

Secondary Outcomes (6)

  • Change in foot pressure distribution

    Week 4 and 8

  • Questionnaire - Pain - Visual analog scale

    Week 0, 4 and 8

  • Insole wearing time

    From week 4 to 8

  • Pain - Pressure pain threshold

    Week 0, 4 and 8

  • Pain mapping

    Week 0, 4 and 8

  • +1 more secondary outcomes

Study Arms (2)

Standard insole

SHAM COMPARATOR

a flat insole

Device: Standard insole

Foot orthotics

EXPERIMENTAL

Custom-made foot orthoses

Device: Foot orthotics

Interventions

Foot orthoticsDEVICE

Insoles for shoes

Foot orthotics
Standard insoleDEVICE

Sham foot orthotic

Standard insole

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with RA (EUALAR 2010) without significant damage or with small erosions but without radiological subluxation in the feet, max Larsen rheumatoid arthritis score 224.
  • With clinical (medical) assessed needs for orthotics (e.g. valgus ankle, pes planus, pes planus transversus, and metatarsophalangeal instability).
  • In stable disease phase (no clinically recognizable, swollen joints (but sore joints)).
  • In stable treatment (no change in DMARD, NSAIDs and steroid treatment the last 4 weeks).

You may not qualify if:

  • Patients with RA using, or regularly used FO, or orthopedic shoes within the last 3 months.
  • Clinically significant joint disease (inflammatory or degenerative) of the knee or hip joints (according to the clinician).
  • Clinically significant back disorder (according to the clinician).
  • Patients with severe ischemic or neurological sequelae in the lower extremities.
  • BMI above 32.
  • Not suitable for a MRI scan (e.g. pacemaker, pregnancy or metal within the body).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

King Christian X's Hospital for Rhuematic Diseases

Gråsten, 6300, Denmark

Location

Department for Rheumatology

Hjørring, 9800, Denmark

Location

Related Publications (1)

  • Simonsen MB, Hirata RP, Naesborg-Andersen K, Leutscher PDC, Horslev-Petersen K, Woodburn J, Andersen MS. Different types of foot orthoses effect on gait mechanics in patients with rheumatoid arthritis. J Biomech. 2022 Jun;139:110496. doi: 10.1016/j.jbiomech.2021.110496. Epub 2021 Apr 30.

    PMID: 33994179DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidPain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Morten B Simonsen, MSc

    Aalborg University, Department of Health Science and Technology and Centre for Clinical Research, North Denmark Regional Hospital, Aalborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: The study design is a cross over study. Patients is instructed in using a placebo FO for one month and receive a custom-made FO, which they will be using for one month.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 8, 2018

First Posted

June 19, 2018

Study Start

October 10, 2018

Primary Completion

November 1, 2019

Study Completion

December 1, 2019

Last Updated

March 3, 2020

Record last verified: 2020-02

Locations

DK(3)