NCT03170947

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: University of Malaga · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2022-01-21
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2017-05-31
• Last updated: 2023-01-18

Locations

1 site across 1 country: Spain