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

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ClinicalTrials.gov Identifier: NCT03170947
Recruitment Status : Not yet recruiting
First Posted : May 31, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Gabriel Gijon-Nogueron, University of Malaga

Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Device: Custom Insoles Device: Standardized insoles Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Insoles in Patients With Rheumatoid Arthritis Through Measurement of Quality of Life and Physical Activity: Randomized Controlled Trial.
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170947


Contacts
Contact: Laura Ramos Petersen, Podiatry 686583936 ext +34 lauraramos.94@hotmail.com
Contact: Gabriel Gijon Nogueron, PhD 951952872 ext +34 gagijon@uma.es

Sponsors and Collaborators
University of Malaga
Investigators
Principal Investigator: Gabriel Gijon Nogueron, PhD University of Malaga

Responsible Party: Gabriel Gijon-Nogueron, Principal Investigator, University of Malaga
ClinicalTrials.gov Identifier: NCT03170947     History of Changes
Other Study ID Numbers: UNIMalaga
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gabriel Gijon-Nogueron, University of Malaga:
Rheumatoid arthritis
Foot
Insoles
Quality of life
Physical Activity

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases