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

NCT03170947 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-01-18

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Malaga

    lead OTHER

Principal Investigators

  • Gabriel Gijon Nogueron, PhD · University of Malaga

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-21
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03170947 on ClinicalTrials.gov