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Effectiveness of Podiatry on Plantar Pain (EPOPLAPAIN)

Primary Purpose

Heel Pain, Plantar Fasciitis, Plantar Pain

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
chiropody
basic orthesis
advantage orthesis
chiropody and advantage orthesis
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heel Pain focused on measuring chiropody, podiatry, insoles, foot orthesis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Heel and plantar pain

Exclusion Criteria:

  • Inflammatory infections and specific organic disease of foot

Sites / Locations

  • Clinica Podologia de la Universidad de malaga
  • Health Science School , University of Malaga

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

Health state and pain of foot with FHSQ

Secondary Outcome Measures

quality of life with EuroQoL 5D (Spanish Version)
biomechanical parameters with Biofoot applications (instrumental systme of dinamic pressure inside shoes)

Full Information

First Posted
April 22, 2009
Last Updated
July 23, 2013
Sponsor
University of Malaga
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1. Study Identification

Unique Protocol Identification Number
NCT00888394
Brief Title
Effectiveness of Podiatry on Plantar Pain
Acronym
EPOPLAPAIN
Official Title
Clinical Effectiveness of Quiropodiatry and Orthesis on Heel and Plantar Pain: Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaga

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heel Pain, Plantar Fasciitis, Plantar Pain
Keywords
chiropody, podiatry, insoles, foot orthesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
312 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
chiropody
Intervention Description
basic procedure of chiropody in podiatry
Intervention Type
Procedure
Intervention Name(s)
basic orthesis
Intervention Description
individual basic orthesis of foot
Intervention Type
Procedure
Intervention Name(s)
advantage orthesis
Intervention Description
advantage orthesis of foot with special material and design
Intervention Type
Procedure
Intervention Name(s)
chiropody and advantage orthesis
Intervention Description
chiropody and advantage orthesis of foot
Primary Outcome Measure Information:
Title
Health state and pain of foot with FHSQ
Time Frame
total score, pre and post intervention and 6 and 12 months of follow up
Secondary Outcome Measure Information:
Title
quality of life with EuroQoL 5D (Spanish Version)
Time Frame
scale 0-100, pre and post intervention and follow up 6 and 12 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Heel and plantar pain Exclusion Criteria: Inflammatory infections and specific organic disease of foot
Facility Information:
Facility Name
Clinica Podologia de la Universidad de malaga
City
Malaga
ZIP/Postal Code
29071
Country
Spain
Facility Name
Health Science School , University of Malaga
City
Malaga
ZIP/Postal Code
29071
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.uma.es/
Description
University of Malaga
URL
http://www.salud.uma.es/
Description
Health Science School
URL
http://www.juntadeandalucia.es/salud/principal/documentos.asp?pagina=ec_op1
Description
Ethics Comite Andalucia
URL
http://www.plannacionalidi.es/plan-idi-public/
Description
R+D Spain

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Effectiveness of Podiatry on Plantar Pain

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