Plantar FasciitisNCT01549678
Plantar Fasciitis Foot Insole
A study testing Total contact insole in people with Plantar Fasciitis, run by Federal University of São Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Total contact insole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2010to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Sao Paulo
São Paulo, São Paulo
Hilda PT Oliveira, 551126910469, hilda_veiga@yahoo.com.br
Jamil MD Natour, PHD, 551155764239, jnatour@unifesp.br
About this study
Official title: Effect of Plantar Fasciitis Foot Insole
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.
- Conditions
- Plantar Fasciitis
- Being tested
- Total contact insole, placebo insole
- Keywords
- Plantar fasciitis, foot pain, insoles, foot function, electronic baropodometer, plantar pressure, gait analysis
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total contact insoleOther
Also called Intervention group
EVA insole shaped on patient´s foot.
placebo insoleOther
Also called Placebo group
EVA insole flat
| Study group | Role | What they receive |
|---|---|---|
| Intervention foot orthoses | Experimental | Ethyl Vinil Acetate EVA insole shaped in the cast of the patient's foot. Receives: Other: Total contact insole |
| Placebo insole | Placebo comparator | EVA flat insole. Receives: Other: placebo insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Six months
Secondary outcomes (8)
FFI
Questionaire of function of the foot
Measured: 6 months
FHSQ-Br
Foot Health Status Questionaire
Measured: 6 months
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
Measured: 6 months
6-MINUTE WALK TEST
Assess functional capacity
Measured: 6 months
SF-36
Assess functional capacity
Measured: 12 months
Likert scale
Likert scale by patients
Measured: 6 months
Baropodometric tests
Evaluates charge gistribution in the feet and gait variables
Measured: 6 months
Time use of insole
Control use of insole
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startAug 2010
- Primary completionApr 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Hilda Alcantara Veiga de Oliveira, Federal University of São Paulo
- Investigators
- Hilda PT Oliveira, Principal investigator, Federal University of São PauloAnamaria PT Jones, PHD, Study director, Federal University of São PauloJamil MD Natour, PHD, Study chair, Chief of Rheumatology, Federal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549678
- Sponsor's protocol ID
- 1349/09
- Status last verified
- Nov 2010
- First submitted
- 7 Mar 2012
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Plantar Fasciitis Foot Insole
- ClinicalTrials.gov ID
- NCT01549678
- Acronym / sponsor ID
- 1349/09
- Conditions
- Plantar Fasciitis
- Keywords
- Plantar fasciitis, foot pain, insoles, foot function, electronic baropodometer, plantar pressure, gait analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Aug 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention foot orthoses | Experimental | Other: Total contact insoleEthyl Vinil Acetate EVA insole shaped in the cast of the patient's foot. |
| Placebo insole | Placebo comparator | Other: placebo insoleEVA flat insole. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total contact insoleAlso: Intervention groupEVA insole shaped on patient´s foot. | Other | Intervention foot orthoses |
| placebo insoleAlso: Placebo groupEVA insole flat | Other | Placebo insole |
Primary outcome
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
8 secondary outcomes
FFI
Time frame: 6 months
FHSQ-Br
Time frame: 6 months
Visual analog scale of pain in feet at reset (VAS)
Time frame: 6 months
6-MINUTE WALK TEST
Time frame: 6 months
SF-36
Time frame: 12 months
Likert scale
Time frame: 6 months
Baropodometric tests
Time frame: 6 months
Time use of insole
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
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Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
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F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
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Not yet recruiting
Radial vs Focused Shockwave Therapy for Plantar Fasciitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total contact insole in people with Plantar Fasciitis, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hilda Oliveira (551126910469, hilda_veiga@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale of pain in feet during walking (VAS) (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2012.