Effectiveness of Podiatry on Plantar Pain (EPOPLAPAIN)

University of Malaga

Status and phase: Completed; Phase 4

Conditions: Plantar Fasciitis; Heel Pain; Plantar Pain

Treatments: Procedure: advantage orthesis; Procedure: chiropody; Procedure: chiropody and advantage orthesis; Procedure: basic orthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT00888394

173908909-8909-4-9

Details and patient eligibility

About

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.

Enrollment: 312 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Heel and plantar pain

Exclusion criteria

• Inflammatory infections and specific organic disease of foot

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

312 participants in 4 patient groups

1

Experimental group

Treatment:

Procedure: chiropody

2

Experimental group

Treatment:

Procedure: basic orthesis

3

Experimental group

Treatment:

Procedure: advantage orthesis

4

Experimental group

Treatment:

Procedure: chiropody and advantage orthesis