Plantar Fasciitis Clinical Trial
— EPOPLAPAINOfficial title:
Clinical Effectiveness of Quiropodiatry and Orthesis on Heel and Plantar Pain: Randomized Control Trial
| Verified date | January 2013 |
| Source | University of Malaga |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 312 |
| Est. completion date | February 2013 |
| Est. primary completion date | May 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Heel and plantar pain Exclusion Criteria: - Inflammatory infections and specific organic disease of foot |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Clinica Podologia de la Universidad de malaga | Malaga | |
| Spain | Health Science School , University of Malaga | Malaga |
| Lead Sponsor | Collaborator |
|---|---|
| University of Malaga |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Health state and pain of foot with FHSQ | total score, pre and post intervention and 6 and 12 months of follow up | Yes | |
| Secondary | quality of life with EuroQoL 5D (Spanish Version) | scale 0-100, pre and post intervention and follow up 6 and 12 months | Yes | |
| Secondary | 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 | Yes |
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