Plantar Fasciitis Foot Insole

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Plantar Fasciitis Foot Insole

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Other: Total contact insole
* Other: placebo insole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention foot orthoses<br>Ethyl Vinil Acetate EVA insole shaped in the cast of the patient's foot. | Other: Total contact insole<br>* EVA insole shaped on patient´s foot.<br>* Other names: Intervention group;|
| Placebo Comparator: Placebo insole<br>EVA flat insole. | Other: placebo insole<br>* EVA insole flat<br>* Other names: Placebo group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale of pain in feet during walking (VAS) | Assessing pain in the feet during walking through a visual analog scale from 0 to 10 | Six months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plantar fasciitis, foot pain, insoles, foot function, electronic baropodometer, plantar pressure, gait analysis