Plantar Fasciitis Foot Insole

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01549678
First received: March 7, 2012
Last updated: NA
Last verified: November 2010
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Plantar Fasciitis Foot Insole

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

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


Secondary Outcome Measures:
  • FFI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Questionaire of function of the foot

  • FHSQ-Br [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Foot Health Status Questionaire

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

  • 6-MINUTE WALK TEST [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Assess functional capacity

  • SF-36 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Assess functional capacity

  • Likert scale [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Likert scale by patients

  • Baropodometric tests [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Evaluates charge gistribution in the feet and gait variables

  • Time use of insole [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 7, 2012
Last Updated: March 7, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2014