Plantar Fasciitis Foot Insole

NCT01549678 | Unknown DMC

• 1 other identifier: 1349/09
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fasciitis

Keywords

Plantar fasciitis; foot pain; insoles; foot function; electronic baropodometer; plantar pressure; gait analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• FFI

  6 months

• FHSQ-Br

  6 months

• Visual analog scale of pain in feet at reset (VAS)

  6 months

• 6-MINUTE WALK TEST

  6 months

• SF-36

  12 months

Study Arms (2)

Intervention foot orthoses

EXPERIMENTAL

Ethyl Vinil Acetate EVA insole shaped in the cast of the patient's foot.

Other: Total contact insole

Placebo insole

PLACEBO COMPARATOR

EVA flat insole.

Other: placebo insole

Interventions

Total contact insole OTHER

EVA insole shaped on patient´s foot.

Also known as: Intervention group

Intervention foot orthoses

placebo insole OTHER

EVA insole flat

Also known as: Placebo group

Placebo insole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Hilda PT Oliveira

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• Anamaria PT Jones, PHD

  Federal University of São Paulo

  STUDY DIRECTOR

• Jamil MD Natour, PHD

  Chief of Rheumatology, Federal

  STUDY CHAIR

Central Study Contacts

Hilda Oliveira

CONTACT

551126910469; hilda_veiga@yahoo.com.br

Jamil MD Natour, PHD

CONTACT

551155764239; jnatour@unifesp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effect of Fasciitis Plantar Foot Insoles

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 9, 2012
• Study Start: August 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 9, 2012

Record last verified: 2010-11

Locations

BR (1)