Effects of Insoles in Patients With Rheumatoid Arthritis: Randomized Controlled Trial.

NCT ID: NCT03170947

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-21
• Study Completion Date: 2024-12-31

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.

Detailed Description

Randomized double-blind clinical trial. Two samples of patients will be taken: the control group, which will consist of patients with rheumatoid arthritis and standardized insoles, and other group, which will consist of patients with rheumatoid arthritis and insoles made with direct adaptation technique (TAD) and patients with rheumatoid arthritis and insoles made with an scanner (CAD-CAM). The variables that the investigators will measure are: age, sex, study level, current occupation, rheumatoid arthritis evolution time, quality of life and physical function, pain and health level and general function of the foot. The investigators will use: an accelerometer, and questionnaires: Foot and Ankle Ability Measures (FAAM), Manchester foot pain and disability index (MFPDI), Medical outcomes study short form-36 (SF-36) y Foot Function Index (FFI). This study will analyze patients in the Universities of Malaga and Salford for 6 months.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Custom insoles

Custom 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.

Group Type: EXPERIMENTAL

Custom Insoles

Intervention Type: DEVICE

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

Standardized insoles will be done by Ethylene-vinyl acetate (EVA) material.

Group Type: ACTIVE_COMPARATOR

Standardized insoles

Intervention Type: DEVICE

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.

Interventions

Custom Insoles

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.

Intervention Type: DEVICE

Standardized insoles

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Gabriel Gijon-Nogueron

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gabriel Gijon Nogueron, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Malaga

Locations

University of Malaga

Málaga, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Laura Ramos Petersen, Podiatry

Role: CONTACT

lauraramos.94@hotmail.com

686583936 ext. +34

Gabriel Gijon Nogueron, PhD

Role: CONTACT

gagijon@uma.es

951952872 ext. +34

Facility Contacts

Gabriel Gijon Nogueron, PhD

Role: primary

gagijon@uma.es

0034626449254

References

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.

Reference Type: DERIVED

PMID: 33560583 (View on PubMed)

Ramos-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.

Reference Type: DERIVED

PMID: 32690521 (View on PubMed)

Other Identifiers

UNIMalaga

Identifier Type: -

Identifier Source: org_study_id