Back to resultsPlantar Fasciitis Foot Insole
Primary Purpose
Plantar Fasciitis
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Total contact insole
placebo insole
Sponsored by
About this trial
This is an interventional treatment trial for Plantar Fasciitis focused on measuring Plantar fasciitis, foot pain, insoles, foot function, electronic baropodometer, plantar pressure, gait analysis
Eligibility Criteria
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.
Sites / Locations
- Federal University of Sao PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention foot orthoses
Placebo insole
Arm Description
Ethyl Vinil Acetate EVA insole shaped in the cast of the patient's foot.
EVA flat insole.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
FFI
Questionaire of function of the foot
FHSQ-Br
Foot Health Status Questionaire
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-MINUTE WALK TEST
Assess functional capacity
SF-36
Assess functional capacity
Likert scale
Likert scale by patients
Baropodometric tests
Evaluates charge gistribution in the feet and gait variables
Time use of insole
Control use of insole
Full Information
NCT ID
NCT01549678
First Posted
March 7, 2012
Last Updated
March 7, 2012
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01549678
Brief Title
Plantar Fasciitis Foot Insole
Official Title
Effect of Plantar Fasciitis Foot Insole
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
Plantar fasciitis, foot pain, insoles, foot function, electronic baropodometer, plantar pressure, gait analysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention foot orthoses
Arm Type
Experimental
Arm Description
Ethyl Vinil Acetate EVA insole shaped in the cast of the patient's foot.
Arm Title
Placebo insole
Arm Type
Placebo Comparator
Arm Description
EVA flat insole.
Intervention Type
Other
Intervention Name(s)
Total contact insole
Other Intervention Name(s)
Intervention group
Intervention Description
EVA insole shaped on patient´s foot.
Intervention Type
Other
Intervention Name(s)
placebo insole
Other Intervention Name(s)
Placebo group
Intervention Description
EVA insole flat
Primary Outcome Measure Information:
Title
Visual analog scale of pain in feet during walking (VAS)
Description
Assessing pain in the feet during walking through a visual analog scale from 0 to 10
Time Frame
Six months
Secondary Outcome Measure Information:
Title
FFI
Description
Questionaire of function of the foot
Time Frame
6 months
Title
FHSQ-Br
Description
Foot Health Status Questionaire
Time Frame
6 months
Title
Visual analog scale of pain in feet at reset (VAS)
Description
Assessing pain in the feet at reset through a visual analog scale from 0 to 10
Time Frame
6 months
Title
6-MINUTE WALK TEST
Description
Assess functional capacity
Time Frame
6 months
Title
SF-36
Description
Assess functional capacity
Time Frame
12 months
Title
Likert scale
Description
Likert scale by patients
Time Frame
6 months
Title
Baropodometric tests
Description
Evaluates charge gistribution in the feet and gait variables
Time Frame
6 months
Title
Time use of insole
Description
Control use of insole
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hilda Oliveira
Phone
551126910469
Email
hilda_veiga@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Jamil MD Natour, PHD
Phone
551155764239
Email
jnatour@unifesp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilda PT Oliveira
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anamaria PT Jones, PHD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jamil MD Natour, PHD
Organizational Affiliation
Chief of Rheumatology, Federal
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilda PT Oliveira
Phone
551126910469
Email
hilda_veiga@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Jamil MD Natour, PHD
Phone
551155764239
Email
jnatour@unifesp.br
12. IPD Sharing Statement
Learn more about this trial
Plantar Fasciitis Foot Insole
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