Effectiveness of Podiatry on Plantar Pain (EPOPLAPAIN)
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.
|Heel Pain Plantar Fasciitis Plantar Pain||Procedure: chiropody Procedure: basic orthesis Procedure: advantage orthesis Procedure: chiropody and advantage orthesis||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Clinical Effectiveness of Quiropodiatry and Orthesis on Heel and Plantar Pain: Randomized Control Trial|
- Health state and pain of foot with FHSQ [ Time Frame: total score, pre and post intervention and 6 and 12 months of follow up ]
- quality of life with EuroQoL 5D (Spanish Version) [ Time Frame: 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) [ Time Frame: Kp in 68 sensors of plantar foot, changes pre-post intervention and 6 and 12 months of follow up ]
|Study Start Date:||September 2009|
|Study Completion Date:||February 2013|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
basic procedure of chiropody in podiatry
Procedure: basic orthesis
individual basic orthesis of foot
Procedure: advantage orthesis
advantage orthesis of foot with special material and design
Procedure: chiropody and advantage orthesis
chiropody and advantage orthesis of foot
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888394
|Clinica Podologia de la Universidad de malaga|
|Malaga, Spain, 29071|
|Health Science School , University of Malaga|
|Malaga, Spain, 29071|