Effectiveness of Podiatry on Plantar Pain

NCT00888394 | Completed Phase 4 DMC

• 1 other identifier: 173908909-8909-4-9
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 2

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.

Conditions

Heel Pain; Plantar Fasciitis; Plantar Pain

Keywords

chiropody; podiatry; insoles; foot orthesis

Outcome Measures

Primary Outcomes (1)

• Health state and pain of foot with FHSQ

  total score, pre and post intervention and 6 and 12 months of follow up

Secondary Outcomes (2)

• 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

Study Arms (4)

1

EXPERIMENTAL

Procedure: chiropody

2

EXPERIMENTAL

Procedure: basic orthesis

3

EXPERIMENTAL

Procedure: advantage orthesis

4

EXPERIMENTAL

Procedure: chiropody and advantage orthesis

Interventions

chiropody PROCEDURE

basic procedure of chiropody in podiatry

1

basic orthesis PROCEDURE

individual basic orthesis of foot

2

advantage orthesis PROCEDURE

advantage orthesis of foot with special material and design

3

chiropody and advantage orthesis PROCEDURE

chiropody and advantage orthesis of foot

4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Heel and plantar pain

You may not qualify if:

• Inflammatory infections and specific organic disease of foot

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (2)

Clinica Podologia de la Universidad de malaga

Málaga, Malaga, 29071, Spain

Location

Health Science School , University of Malaga

Málaga, Malaga, 29071, Spain

Location

Related Links

• University of Malaga
• Health Science School
• Ethics Comite Andalucia
• R+D Spain

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 22, 2009
• First Posted: April 27, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: February 1, 2013
• Last Updated: July 24, 2013

Record last verified: 2013-01

Locations

ES (2)