Effects of Insoles in Patients With Rheumatoid Arthritis: Randomized Controlled Trial.
1 other identifier
interventional
96
1 country
1
Brief Summary
Deformity and foot pain is nearly omnipresent (90%) in rheumatoid arthritis (RA), due to the interaction between inflammation and abnormal biomechanical. These cause instability in the hindfoot, which cause deformity of the forefoot, and they cause more pressure on the plantar forefoot and more pain during daily activities. Non-pharmacological interventions (insole, footwear) have an important role, reducing pain and disability, increasing the effectiveness and improving daily activities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable rheumatoid-arthritis
Started Jan 2022
Typical duration for not_applicable rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2017
CompletedFirst Posted
Study publicly available on registry
May 31, 2017
CompletedStudy Start
First participant enrolled
January 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJanuary 18, 2023
January 1, 2023
2.9 years
May 26, 2017
January 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline Active graph (bracelet) at 3 months
This outcome will be measured with an activity monitor, accelerometer
one week, one month and three months
Secondary Outcomes (4)
Change from Baseline quality of life at 3 months
one week, one month and three months
Change from Baseline foot function 3 months
one week, one month and three months
Change from Baseline pain intensity at 3 months
one week, one month and three months
Change from Baseline physical activity at 3 months
one week, one month and three months
Study Arms (2)
Custom insoles
EXPERIMENTALCustom insoles will make with CAD-CAM using a laser scanning and casting for its construction. Custom insoles will make with direct adaptation technique (TAD) being of pvc resin.
Standardized insoles
ACTIVE COMPARATORStandardized insoles will be done by Ethylene-vinyl acetate (EVA) material.
Interventions
Custom insoles will make with CAD-CAM using a laser scanning and casting for its construction. All this needs the assistance of a computer. From the digital image of a positive of the limb in foam the insole will be obtained. Custom insoles make with direct adaptation technique (TAD) being of pvc resin. Once the resins are cut and with a temperature of 90º, they will be adapted to the foot (which will be protected with a sock) of the patient with the help of a vacuum. To this technique subtalar joint will be in a neutral position and metatarsal joints will be aligned.
Standardized insoles were done by EVA material with shore of 18 and 180 kg/cm3 and manufactured, with an extension of 3/4. It was in contact with heel and plantar arch.
Eligibility Criteria
You may qualify if:
- More than 18 years of age
- Early RA
- To meet the criteria of American College of Rheumatology
- History of bilateral subtalar and/or ankle and/or talonavicular pain
- Informed consent
- Normal range of motions at the ankle, subtalar, and midtarsal joints.
You may not qualify if:
- Concomitant musculoskeletal disease
- Central or peripheral nervous system disease
- Endocrine disorders, especially diabetes mellitus with a level of insufficient foot sensitivity
- Patients with a history of orthopedic foot surgery
- Those currently using foot orthoses.
- Patients with foot trauma in the last 6 months previous to the study
- Vascular diseases affecting the foot, active synovitis and edema.
- Normal daily walking aids will be not permitted.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Malaga
Málaga, 29071, Spain
Related Publications (2)
Ramos-Petersen L, Nester CJ, Ortega-Avila AB, Skidmore S, Gijon-Nogueron G. A qualitative study exploring the experiences and perceptions of patients with rheumatoid arthritis before and after wearing foot orthoses for 6 months. Health Soc Care Community. 2021 May;29(3):829-836. doi: 10.1111/hsc.13316. Epub 2021 Feb 9.
PMID: 33560583DERIVEDRamos-Petersen L, Nester CJ, Gijon-Nogueron G, Ortega-Avila AB. Foot orthoses for people with rheumatoid arthritis, involving quantitative and qualitative outcomes: protocol for a randomised controlled trial. BMJ Open. 2020 Jul 19;10(7):e036433. doi: 10.1136/bmjopen-2019-036433.
PMID: 32690521DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriel Gijon Nogueron, PhD
University of Malaga
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 26, 2017
First Posted
May 31, 2017
Study Start
January 21, 2022
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
January 18, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share