Effectiveness of Podiatry on Plantar Pain (EPOPLAPAIN)

July 23, 2013 updated by: Dr. Antonio I Cuesta-Vargas, University of Malaga

Clinical Effectiveness of Quiropodiatry and Orthesis on Heel and Plantar Pain: Randomized Control Trial

MAIN OBJECTIVE: To value the effectiveness of the different quiropody interventions in the heel pain.

SECONDARY OBJECTIVES: To evaluate the effectiveness of lasw different technologies in front of each one of the other experimental technologies. To analyze the state of general health and of quality of the patients' life in all the treatment groups. To analyze the study cost-effectiveness of each one of the experimental interventions. DESIGN: randomized controled trial, prospective.

SUBJECT OF STUDY: Patient that go to the Assistance Educational Unit of Podología of the E.U. Sciences of the Health with footpain like consultation reason.

INTERVENTION: Establishment of four experimental groups with intervention varied podológica. He/she will be carried out a complete pursuit with valuations at the 1,2, 6, 12 and 24 months, by means of pain scales and function of the foot (FHSQ), the index postural of the foot (FPI), the study of pressures by means of biofoot/IBV and of the state of general health (SF-12) and quality of life (Euroqol).

VARIABLES: Of intervention; treatment basic orthopodiatry, treatment advanced orthopodiatry, of treatment quiropody. Of result: pain and function of the foot (FHSQ), of the state of general health (SF12) and quality of life (Euroqol). Variables of characterization of the sample.

ANALYSIS DATA: Descriptive statistic, with measures of central tendency and dispersion of the study variables. They will be carried out statistical inferenciales between the main variables of intervention and result (square chi, t Student, ANOVA, Mann-Whitney, Wilcoxon, according to types and normality of variables). Likewise, measures of the size of the effect will settle down in the main variables of result, by means of the relative reduction of the risk, absolute risk and odds ratio, with their respective intervals of trust.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Spain
      • Malaga, Spain, 29071
        • Clinica Podologia de la Universidad de malaga
      • Malaga, Spain, 29071
        • Health Science School , University of Malaga

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Heel and plantar pain

Exclusion Criteria:

  • Inflammatory infections and specific organic disease of foot

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: 1
Procedure: chiropody
basic procedure of chiropody in podiatry
Experimental: 2
Procedure: basic orthesis
individual basic orthesis of foot
Experimental: 3
Procedure: advantage orthesis
advantage orthesis of foot with special material and design
Experimental: 4
Procedure: chiropody and advantage orthesis
chiropody and advantage orthesis of foot

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Health state and pain of foot with FHSQ
Time Frame: total score, pre and post intervention and 6 and 12 months of follow up
total score, pre and post intervention and 6 and 12 months of follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
quality of life with EuroQoL 5D (Spanish Version)
Time Frame: scale 0-100, pre and post intervention and follow up 6 and 12 months
scale 0-100, pre and post intervention and follow up 6 and 12 months
biomechanical parameters with Biofoot applications (instrumental systme of dinamic pressure inside shoes)
Time Frame: Kp in 68 sensors of plantar foot, changes pre-post intervention and 6 and 12 months of follow up
Kp in 68 sensors of plantar foot, changes pre-post intervention and 6 and 12 months of follow up

Collaborators and Investigators

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

Sponsor

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.

Helpful Links

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

September 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

April 22, 2009

First Submitted That Met QC Criteria

April 24, 2009

First Posted (Estimate)

April 27, 2009

Study Record Updates

Last Update Posted (Estimate)

July 24, 2013

Last Update Submitted That Met QC Criteria

July 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 173908909-8909-4-9

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.

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