Clinical Trials Directory

Trials / Completed

CompletedNCT00888394

Effectiveness of Podiatry on Plantar Pain

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
312 (actual)
Sponsor
University of Malaga · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREchiropodybasic procedure of chiropody in podiatry
PROCEDUREbasic orthesisindividual basic orthesis of foot
PROCEDUREadvantage orthesisadvantage orthesis of foot with special material and design
PROCEDUREchiropody and advantage orthesischiropody and advantage orthesis of foot

Timeline

Start date
2009-09-01
Primary completion
2010-05-01
Completion
2013-02-01
First posted
2009-04-27
Last updated
2013-07-24

Locations

2 sites across 1 country: Spain

Source: ClinicalTrials.gov record NCT00888394. Inclusion in this directory is not an endorsement.