Clinical trial NCT00888394: Effectiveness of Podiatry on Plantar Pain
Official title: Clinical Effectiveness of Quiropodiatry and Orthesis on Heel and Plantar Pain: Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heel Pain
Plantar Fasciitis
Plantar Pain
Keywords: chiropody
podiatry
insoles
foot orthesis
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2009-04-27
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Heel and plantar pain

Exclusion Criteria:

* Inflammatory infections and specific organic disease of foot

Primary outcomes:
measure: Health state and pain of foot with FHSQ
timeFrame: total score, pre and post intervention and 6 and 12 months of follow up
Secondary outcomes:
measure: quality of life with EuroQoL 5D (Spanish Version)
timeFrame: scale 0-100, pre and post intervention and follow up 6 and 12 months
measure: biomechanical parameters with Biofoot applications (instrumental systme of dinamic pressure inside shoes)
timeFrame: Kp in 68 sensors of plantar foot, changes pre-post intervention and 6 and 12 months of follow up
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Clinica Podologia de la Universidad de malaga
city: Malaga
country: Spain
facility: Health Science School , University of Malaga
Study officials:
References: