Effectiveness of Podiatry on Plantar Pain (EPOPLAPAIN)

This study is currently recruiting participants.

Verified January 2013 by University of Malaga

Sponsor:

Information provided by (Responsible Party):

Dr. Antonio I Cuesta-Vargas, University of Malaga

ClinicalTrials.gov Identifier:

NCT00888394

First received: April 22, 2009

Last updated: January 8, 2013

Last verified: January 2013

History of Changes

Purpose

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	Intervention	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
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Clinical Effectiveness of Quiropodiatry and Orthesis on Heel and Plantar Pain: Randomized Control Trial

Resource links provided by NLM:

MedlinePlus related topics: Foot Health

Drug Information available for: Imidacloprid

U.S. FDA Resources

Further study details as provided by University of Malaga:

Primary Outcome Measures:

Health state and pain of foot with FHSQ [ Time Frame: total score, pre and post intervention and 6 and 12 months of follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

quality of life with EuroQoL 5D (Spanish Version) [ Time Frame: scale 0-100, pre and post intervention and follow up 6 and 12 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	312
Study Start Date:	September 2009
Estimated Study Completion Date:	February 2013
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Heel and plantar pain

Exclusion Criteria:

Inflammatory infections and specific organic disease of foot

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888394

Contacts

Contact: Antonio Cuesta-Vargas, PhD

0034952137551

acuesta@uma.es

Locations

Spain
Health Science School , University of Malaga	Recruiting
Malaga, Spain, 29071
Contact: Antonio Cuesta-Vargas, PhD
Principal Investigator: Antonio Cuesta_Vargas, PhD
Clinica Podologia de la Universidad de malaga	Recruiting
Malaga, Spain, 29071
Contact: Antonio I Cuesta-Vargas, PhD
Sub-Investigator: Ana Maria Jimenez-Cebrian, Msc

Sponsors and Collaborators

University of Malaga

More Information

Additional Information:

University of Malaga This link exits the ClinicalTrials.gov site

Health Science School This link exits the ClinicalTrials.gov site

Ethics Comite Andalucia This link exits the ClinicalTrials.gov site

R+D Spain

No publications provided

Responsible Party:	Dr. Antonio I Cuesta-Vargas, PhD, University of Malaga
ClinicalTrials.gov Identifier:	NCT00888394 History of Changes
Other Study ID Numbers:	173908909-8909-4-9
Study First Received:	April 22, 2009
Last Updated:	January 8, 2013
Health Authority:	Spain: Ethics Committee

Keywords provided by University of Malaga:

chiropody
podiatry
insoles
foot orthesis

Additional relevant MeSH terms:

Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases
Imidacloprid

Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013

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