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

Effects of Insoles in Patients With Rheumatoid Arthritis Through Measurement of Quality of Life and Physical Activity: Randomized Controlled Trial.

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.

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.

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.