We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Plantar Fasciitis Foot Insole

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Hilda Alcantara Veiga de Oliveira, Federal University of São Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01549678
First Posted: March 9, 2012
Last Update Posted: March 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Hilda Alcantara Veiga de Oliveira, Federal University of São Paulo
  Purpose
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.

Condition Intervention
Plantar Fasciitis Other: Total contact insole Other: placebo insole

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Plantar Fasciitis Foot Insole

Resource links provided by NLM:


Further study details as provided by Hilda Alcantara Veiga de Oliveira, Federal University of São Paulo:

Primary Outcome Measures:
  • Visual analog scale of pain in feet during walking (VAS) [ Time Frame: Six months ]
    Assessing pain in the feet during walking through a visual analog scale from 0 to 10


Secondary Outcome Measures:
  • FFI [ Time Frame: 6 months ]
    Questionaire of function of the foot

  • FHSQ-Br [ Time Frame: 6 months ]
    Foot Health Status Questionaire

  • Visual analog scale of pain in feet at reset (VAS) [ Time Frame: 6 months ]
    Assessing pain in the feet at reset through a visual analog scale from 0 to 10

  • 6-MINUTE WALK TEST [ Time Frame: 6 months ]
    Assess functional capacity

  • SF-36 [ Time Frame: 12 months ]
    Assess functional capacity

  • Likert scale [ Time Frame: 6 months ]
    Likert scale by patients

  • Baropodometric tests [ Time Frame: 6 months ]
    Evaluates charge gistribution in the feet and gait variables

  • Time use of insole [ Time Frame: 6 months ]
    Control use of insole


Estimated Enrollment: 74
Study Start Date: August 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention foot orthoses
Ethyl Vinil Acetate EVA insole shaped in the cast of the patient's foot.
Other: Total contact insole
EVA insole shaped on patient´s foot.
Other Name: Intervention group
Placebo Comparator: Placebo insole
EVA flat insole.
Other: placebo insole
EVA insole flat
Other Name: Placebo group

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549678


Contacts
Contact: Hilda Oliveira 551126910469 hilda_veiga@yahoo.com.br
Contact: Jamil MD Natour, PHD 551155764239 jnatour@unifesp.br

Locations
Brazil
Federal University of Sao Paulo Recruiting
Sao Paulo, Brazil
Contact: Hilda PT Oliveira    551126910469    hilda_veiga@yahoo.com.br   
Contact: Jamil MD Natour, PHD    551155764239    jnatour@unifesp.br   
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Hilda PT Oliveira Federal University of Sao Paulo
Study Director: Anamaria PT Jones, PHD Federal University of Sao Paulo
Study Chair: Jamil MD Natour, PHD Chief of Rheumatology, Federal
  More Information

Responsible Party: Hilda Alcantara Veiga de Oliveira, Effect of Fasciitis Plantar Foot Insoles, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01549678     History of Changes
Other Study ID Numbers: 1349/09
First Submitted: March 7, 2012
First Posted: March 9, 2012
Last Update Posted: March 9, 2012
Last Verified: November 2010

Keywords provided by Hilda Alcantara Veiga de Oliveira, Federal University of São Paulo:
Plantar fasciitis
foot pain
insoles
foot function
electronic baropodometer
plantar pressure
gait analysis

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases