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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Device: Custom Insoles
* Device: Standardized insoles


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Custom insoles<br>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. | Device: Custom Insoles<br>* 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.<br>|
| Active Comparator: Standardized insoles<br>Standardized insoles will be done by Ethylene-vinyl acetate (EVA) material. | Device: Standardized insoles<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline quality of life at 3 months | This outcome will be measured with a self-reported questionnaire (SF-36) | one week, one month and three months | 
| Change from Baseline foot function 3 months | This outcome will be measured with a self-reported questionnaire (foot function index) | one week, one month and three months | 
| Change from Baseline pain intensity at 3 months | This outcome will be measured with a self-reported questionnaire (Manchester foot pain and disability index) | one week, one month and three months | 
| Change from Baseline physical activity at 3 months | This outcome will be measured with a self-reported questionnaire (foot and ankle ability measure) | one week, one month and three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid arthritis, Foot, Insoles, Quality of life, Physical Activity