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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03482518 |
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Date of registration:
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15/03/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effectiveness of Postural Insoles Adapted in Slippers for People With Persistent Heel Pain
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Scientific title:
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Effectiveness of Postural Insoles Adapted in Slippers for People With Persistent Heel Pain and Metatarsalgias: a Clinical, Controlled, Randomized and Double Blind Study |
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Date of first enrolment:
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April 17, 2018 |
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Target sample size:
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66 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03482518 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Marcelo Cardoso de Souza, PT,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidade Federal do Rio Grande do Norte |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients of both sexes with a diagnosis of persistent back pain and / or pain in the
head region of the metatarsals for more than 3 months, aged 18-60 years, accustomed to
wearing slippers that are not performing other types of physical therapy and sign the
ICF.
Exclusion Criteria:
- Patients with foot wounds, previous foot and ankle surgeries, rheumatic diseases and /
or skin diseases and those reporting that they can not wear slippers.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Metatarsalgia
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Heel Pain Syndrome
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Intervention(s)
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Other: custom slippers with perforated synthetic leather cover.
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Primary Outcome(s)
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Change in VAS - Visual Analog Scale
[Time Frame: in baseline and 12 week]
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Secondary Outcome(s)
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Change in 6MWT - 6-minute walk test
[Time Frame: baseline and 12 week]
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Change in FAAM - Foot and Ankle Ability Measure
[Time Frame: baseline and 12 week]
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Change in FFI - Foot Function Index questionnaire
[Time Frame: baseline and 12 week]
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Secondary ID(s)
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UFRNCHINELOS
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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