Effectiveness of Podiatry on Plantar Pain (EPOPLAPAIN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Antonio I Cuesta-Vargas, University of Malaga
ClinicalTrials.gov Identifier:
NCT00888394
First received: April 22, 2009
Last updated: July 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Heel Pain
Plantar Fasciitis
Plantar Pain
Procedure: chiropody
Procedure: basic orthesis
Procedure: advantage orthesis
Procedure: chiropody and advantage orthesis
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Effectiveness of Quiropodiatry and Orthesis on Heel and Plantar Pain: Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by University of Malaga:

Primary Outcome Measures:
  • Health state and pain of foot with FHSQ [ Time Frame: total score, pre and post intervention and 6 and 12 months of follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • quality of life with EuroQoL 5D (Spanish Version) [ Time Frame: scale 0-100, pre and post intervention and follow up 6 and 12 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 312
Study Start Date: September 2009
Study Completion Date: February 2013
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: chiropody
basic procedure of chiropody in podiatry
Experimental: 2 Procedure: basic orthesis
individual basic orthesis of foot
Experimental: 3 Procedure: advantage orthesis
advantage orthesis of foot with special material and design
Experimental: 4 Procedure: chiropody and advantage orthesis
chiropody and advantage orthesis of foot

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Heel and plantar pain

Exclusion Criteria:

  • Inflammatory infections and specific organic disease of foot
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888394

Locations
Spain
Health Science School , University of Malaga
Malaga, Spain, 29071
Clinica Podologia de la Universidad de malaga
Malaga, Spain, 29071
Sponsors and Collaborators
University of Malaga
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Antonio I Cuesta-Vargas, PhD, University of Malaga
ClinicalTrials.gov Identifier: NCT00888394     History of Changes
Other Study ID Numbers: 173908909-8909-4-9
Study First Received: April 22, 2009
Last Updated: July 23, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by University of Malaga:
chiropody
podiatry
insoles
foot orthesis

Additional relevant MeSH terms:
Fasciitis, Plantar
Fasciitis
Musculoskeletal Diseases
Foot Diseases
Imidacloprid
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014