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

Phase

N/A

Condition

Arthritis And Arthritic Pain

Joint Injuries

Rheumatoid Arthritis

Treatment

N/A

Clinical Study ID

NCT03170947

UNIMalaga

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Concomitant musculoskeletal disease
Central or peripheral nervous system disease
Endocrine disorders, especially diabetes mellitus with a level of insufficient footsensitivity
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.

Study Design

January 21, 2022

December 31, 2024

Study 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.

Connect with a study center

University of Malaga
Malaga, 29071
Spain
Active - Recruiting

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