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

January 16, 2023 updated by: Gabriel Gijon-Nogueron, University of Malaga

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Gabriel Gijon Nogueron, PhD
  • Phone Number: +34 951952872
  • Email: gagijon@uma.es

Study Locations

  • Spain
      • Malaga, Spain, 29071
        • Recruiting
        • University of Malaga
        • Contact:
          • Gabriel Gijon Nogueron, PhD
          • Phone Number: 0034626449254
          • Email: gagijon@uma.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Custom insoles
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

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.
Active Comparator: Standardized insoles
Standardized insoles will be done by Ethylene-vinyl acetate (EVA) material.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Active graph (bracelet) at 3 months
Time Frame: one week, one month and three 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
Time Frame: one week, one month and three 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
Time Frame: one week, one month and three 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
Time Frame: one week, one month and three 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
Time Frame: one week, one month and three months
This outcome will be measured with a self-reported questionnaire (foot and ankle ability measure)
one week, one month and three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaga

Investigators

  • Principal Investigator: Gabriel Gijon Nogueron, PhD, University of Malaga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2022

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

May 26, 2017

First Submitted That Met QC Criteria

May 30, 2017

First Posted (Actual)

May 31, 2017

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 16, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNIMalaga

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Custom Insoles

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe