Effectiveness of Podiatry on Plantar Pain

Phase 4

Completed

• Conditions: Heel Pain; Plantar Fasciitis; Plantar Pain
• Interventions: Procedure: chiropody and advantage orthesis; Procedure: advantage orthesis; Procedure: chiropody; Procedure: basic orthesis

• Registration Number: NCT00888394
• Lead Sponsor: University of Malaga

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-22
• Study First Submitted QC: 2009-04-24
• Study First Posted: 2009-04-27
• Study Start: 2009-09
• Primary Completion: 2010-05
• Status Verified: 2013-01
• Study Completion: 2013-02
• Last Update Submitted: 2013-07-23
• Last Update Posted: 2013-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

• Heel and plantar pain

Exclusion Criteria

• Inflammatory infections and specific organic disease of foot

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	chiropody and advantage orthesis	-
3	advantage orthesis	-
1	chiropody	-
2	basic orthesis	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Clinica Podologia de la Universidad de malaga; 🇪🇸 Malaga, Spain

Health Science School , University of Malaga; 🇪🇸 Malaga, Spain