Effectiveness of Podiatry on Plantar Pain

Study Overview
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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.

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

Conditions
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Plantar Fasciitis, Heel Pain, Plantar Pain

Intervention / Treatment
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* Procedure: chiropody
* Procedure: basic orthesis
* Procedure: advantage orthesis
* Procedure: chiropody and advantage orthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Heel and plantar pain Exclusion Criteria: Inflammatory infections and specific organic disease of foot

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Procedure: chiropody<br>* basic procedure of chiropody in podiatry<br>|
| Experimental: 2<br> | Procedure: basic orthesis<br>* individual basic orthesis of foot<br>|
| Experimental: 3<br> | Procedure: advantage orthesis<br>* advantage orthesis of foot with special material and design<br>|
| Experimental: 4<br> | Procedure: chiropody and advantage orthesis<br>* chiropody and advantage orthesis of foot<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life with EuroQoL 5D (Spanish Version) |  | 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) |  | Kp in 68 sensors of plantar foot, changes pre-post intervention and 6 and 12 months of follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chiropody, podiatry, insoles, foot orthesis