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Effectiveness of Podiatry on Plantar Pain

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00888394
Acronym
EPOPLAPAIN
Enrollment
312
Registered
2009-04-27
Start date
2009-09-30
Completion date
2013-02-28
Last updated
2013-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heel Pain, Plantar Fasciitis, Plantar Pain

Keywords

chiropody, podiatry, insoles, foot orthesis

Brief 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.

Interventions

PROCEDUREchiropody

basic procedure of chiropody in podiatry

PROCEDUREbasic orthesis

individual basic orthesis of foot

PROCEDUREadvantage orthesis

advantage orthesis of foot with special material and design

PROCEDUREchiropody and advantage orthesis

chiropody and advantage orthesis of foot

Sponsors

University of Malaga
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Heel and plantar pain

Exclusion criteria

* Inflammatory infections and specific organic disease of foot

Design outcomes

Primary

MeasureTime frame
Health state and pain of foot with FHSQtotal score, pre and post intervention and 6 and 12 months of follow up

Secondary

MeasureTime 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026