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
Recruitment status was Recruiting
Sponsor:
Federal University of São Paulo
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
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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
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 May 23, 2013