Effectiveness of Podiatry on Plantar Pain (EPOPLAPAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00888394
Recruitment Status : Completed
First Posted : April 27, 2009
Last Update Posted : July 24, 2013
Information provided by (Responsible Party):
Dr. Antonio I Cuesta-Vargas, University of Malaga

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Heel Pain Plantar Fasciitis Plantar Pain Procedure: chiropody Procedure: basic orthesis Procedure: advantage orthesis Procedure: chiropody and advantage orthesis Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Effectiveness of Quiropodiatry and Orthesis on Heel and Plantar Pain: Randomized Control Trial
Study Start Date : September 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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

Primary Outcome Measures :
  1. Health state and pain of foot with FHSQ [ Time Frame: total score, pre and post intervention and 6 and 12 months of follow up ]

Secondary Outcome Measures :
  1. quality of life with EuroQoL 5D (Spanish Version) [ Time Frame: scale 0-100, pre and post intervention and follow up 6 and 12 months ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Heel and plantar pain

Exclusion Criteria:

  • Inflammatory infections and specific organic disease of foot

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 identifier (NCT number): NCT00888394

Clinica Podologia de la Universidad de malaga
Malaga, Spain, 29071
Health Science School , University of Malaga
Malaga, Spain, 29071
Sponsors and Collaborators
University of Malaga

Additional Information:
Responsible Party: Dr. Antonio I Cuesta-Vargas, PhD, University of Malaga Identifier: NCT00888394     History of Changes
Other Study ID Numbers: 173908909-8909-4-9
First Posted: April 27, 2009    Key Record Dates
Last Update Posted: July 24, 2013
Last Verified: January 2013

Keywords provided by Dr. Antonio I Cuesta-Vargas, University of Malaga:
foot orthesis

Additional relevant MeSH terms:
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs