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

University of Malaga

Status: Enrolling

Conditions: Rheumatoid Arthritis

Treatments: Device: Custom Insoles; Device: Standardized insoles

Study type: Interventional

Funder types: Other

Identifiers

NCT03170947

UNIMalaga

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups

Custom insoles

Experimental group

Description:

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.

Treatment:

Device: Custom Insoles

Standardized insoles

Active Comparator group

Description:

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

Treatment:

Device: Standardized insoles