Effectiveness of Podiatry on Plantar Pain

NCT ID: NCT00888394

Last Updated: 2013-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Heel Pain Plantar Fasciitis Plantar Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

chiropody

Intervention Type PROCEDURE

basic procedure of chiropody in podiatry

2

Group Type EXPERIMENTAL

basic orthesis

Intervention Type PROCEDURE

individual basic orthesis of foot

3

Group Type EXPERIMENTAL

advantage orthesis

Intervention Type PROCEDURE

advantage orthesis of foot with special material and design

4

Group Type EXPERIMENTAL

chiropody and advantage orthesis

Intervention Type PROCEDURE

chiropody and advantage orthesis of foot

Interventions

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chiropody

basic procedure of chiropody in podiatry

Intervention Type PROCEDURE

basic orthesis

individual basic orthesis of foot

Intervention Type PROCEDURE

advantage orthesis

advantage orthesis of foot with special material and design

Intervention Type PROCEDURE

chiropody and advantage orthesis

chiropody and advantage orthesis of foot

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Heel and plantar pain

Exclusion Criteria

* Inflammatory infections and specific organic disease of foot
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaga

OTHER

Sponsor Role lead

Responsible Party

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Dr. Antonio I Cuesta-Vargas

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinica Podologia de la Universidad de malaga

Málaga, Malaga, Spain

Site Status

Health Science School , University of Malaga

Málaga, Malaga, Spain

Site Status

Countries

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Spain

Related Links

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Other Identifiers

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173908909-8909-4-9

Identifier Type: -

Identifier Source: org_study_id

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