Plantar Fasciitis Foot Insole

Plantar Fasciitis Clinical Trial

Official title:

Effect of Plantar Fasciitis Foot Insole

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01549678
• Other study ID #: 1349/09
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2012
• Last updated: March 7, 2012
• Start date: August 2010
• Est. completion date: August 2012

Study information

• Verified date: November 2010
• Source: Federal University of São Paulo
• Contact: Hilda Oliveira
• Phone: 551126910469
• Email: hilda_veiga[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: August 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Other:
• Total contact insole
EVA insole shaped on patient´s foot.
• placebo insole
EVA insole flat

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	FFI	Questionaire of function of the foot	6 months	Yes
Secondary	FHSQ-Br	Foot Health Status Questionaire	6 months	Yes
Secondary	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	Yes
Secondary	6-MINUTE WALK TEST	Assess functional capacity	6 months	Yes
Secondary	SF-36	Assess functional capacity	12 months	Yes
Secondary	Likert scale	Likert scale by patients	6 months	Yes
Secondary	Baropodometric tests	Evaluates charge gistribution in the feet and gait variables	6 months	Yes
Secondary	Time use of insole	Control use of insole	6 months	Yes