ClinicalTrials.gg
Status unknownNCT01549678Updated Mar 9, 2012

Plantar Fasciitis Foot Insole

An interventional study of Total contact insole and placebo insole in Plantar Fasciitis, sponsored by Federal University of São Paulo. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-09.

Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Plantar Fasciitis

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Keywords

  • Plantar fasciitis
  • foot pain
  • insoles
  • foot function
  • electronic baropodometer
  • plantar pressure
  • gait analysis
03

In context

Fasciitis, Plantar

273 studies on the registry are indexed under Fasciitis, Plantar; 71 are open to participants now.

This study's planned enrollment of 74 is above the median of 56 across 238 interventional studies indexed under Fasciitis, Plantar.

Browse Fasciitis, Plantar studies →

Lead sponsor

Federal University of São Paulo is the lead sponsor of 438 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
74 participants (estimated)

Study arms

  • Experimental
    Intervention foot orthoses

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

    Other: Total contact insole

  • Placebo comparator
    Placebo insole

    EVA flat insole.

    Other: placebo insole

Interventions

  • OtherTotal contact insole

    EVA insole shaped on patient´s foot.

    Also known as: Intervention group

  • Otherplacebo insole

    EVA insole flat

    Also known as: Placebo group

06

What researchers measure

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

    Time frame: Six months

Secondary outcomes

  1. FFI

    Questionaire of function of the foot

    Time frame: 6 months

  2. FHSQ-Br

    Foot Health Status Questionaire

    Time frame: 6 months

  3. 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

    Time frame: 6 months

  4. 6-MINUTE WALK TEST

    Assess functional capacity

    Time frame: 6 months

  5. SF-36

    Assess functional capacity

    Time frame: 12 months

  6. Likert scale

    Likert scale by patients

    Time frame: 6 months

  7. Baropodometric tests

    Evaluates charge gistribution in the feet and gait variables

    Time frame: 6 months

  8. Time use of insole

    Control use of insole

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Federal University of Sao Paulo
    São Paulo, São Paulo, Brazil
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2010, a primary completion of Apr 2012 and a completion of Aug 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2012
First posted
Mar 9, 2012
Start
Aug 2010
Primary completionEst.
Apr 2012
CompletionEst.
Aug 2012
Last update
Mar 9, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01549678
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Responsible party
Hilda Alcantara Veiga de Oliveira (Effect of Fasciitis Plantar Foot Insoles, Federal University of São Paulo) — Principal investigator
First posted
Mar 9, 2012
Start date
Aug 2010
Primary completion
Apr 2012 (estimated)
Completion
Aug 2012 (estimated)
Last update
Mar 9, 2012

Study contacts

Hilda Oliveira
Contact
hilda_veiga@yahoo.com.br
551126910469
Jamil MD Natour, PHD
Contact
jnatour@unifesp.br
551155764239
Hilda PT Oliveira
principal investigator · Federal University of São Paulo
Anamaria PT Jones, PHD
study director · Federal University of São Paulo
Jamil MD Natour, PHD
study chair · Chief of Rheumatology, Federal

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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