Plantar Fasciitis Foot Insole

Not Applicable

• Conditions: Plantar Fasciitis
• Interventions: Other: Total contact insole; Other: placebo insole

• Registration Number: NCT01549678
• Lead Sponsor: Federal University of São Paulo

Brief Summary

The hypothesis to be tested is that the use of total contact insoles for six months reduces foot pain, improves function and quality of life of patients diagnosed with plantar fasciitis.

Detailed Description

Patients diagnosed with plantar fasciitis, foot pain with VAS between 3 - 8 for walk, over 18 years, regardless of gender who agreed to participate and signing the consent form. Pacietes We excluded patients with other symptomatic lower limb musculoskeletal diseases, diabetes mellitus, rigid deformities in the feet, which made use of insoles, physiotherapy or injections in feet and ankles in the last three months, and previous surgery or planned within the next twelve months.

Study Timeline

• Study Start: 2010-08
• Status Verified: 2010-11
• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-07
• Last Update Submitted: 2012-03-07
• Study First Posted: 2012-03-09
• Last Update Posted: 2012-03-09
• Primary Completion: 2012-04
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Patients over 18 years of age with a diagnosis of PF and foot pain while walking ranging from 3 to 8 points on a 10-point pain scale were analyzed

Exclusion Criteria

• Patients with other musculoskeletal conditions in symptomatic lower limbs, inflammatory conditions of the central or peripheral nervous systems, diabetes mellitus or an inability to walk.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention foot orthoses	Total contact insole	Ethyl Vinil Acetate EVA insole shaped in the cast of the patient's foot.
Placebo insole	placebo insole	EVA flat insole.

Primary Outcome Measures

Name	Time	Method
Visual analog scale of pain in feet during walking (VAS)	Six months	Assessing pain in the feet during walking through a visual analog scale from 0 to 10

Secondary Outcome Measures

Name	Time	Method
FFI	6 months	Questionaire of function of the foot
FHSQ-Br	6 months	Foot Health Status Questionaire
Visual analog scale of pain in feet at reset (VAS)	6 months	Assessing pain in the feet at reset through a visual analog scale from 0 to 10
6-MINUTE WALK TEST	6 months	Assess functional capacity
SF-36	12 months	Assess functional capacity
Likert scale	6 months	Likert scale by patients
Baropodometric tests	6 months	Evaluates charge gistribution in the feet and gait variables
Time use of insole	6 months	Control use of insole

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil