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Completed

NCT Number: NCT00888394

Effectiveness of Podiatry on Plantar Pain

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinica Podologia de la Universidad de malaga, Málaga, Malaga, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Heel and plantar pain

Exclusion criteria

  • Inflammatory infections and specific organic disease of foot

Treatment and study plan

chiropody

Procedure

basic procedure of chiropody in podiatry

basic orthesis

Procedure

individual basic orthesis of foot

advantage orthesis

Procedure

advantage orthesis of foot with special material and design

chiropody and advantage orthesis

Procedure

chiropody and advantage orthesis of foot

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Registry information

Official study title

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

Acronym: EPOPLAPAIN

Important dates

Study start
2009
Primary completion
2010
Study completion
2013
First posted
Apr 27, 2009
Registry last updated
Jul 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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