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NCT03511677

Insole on Morton's Neuroma

Completed NA Last updated 30 April 2018
What this trial tests

NA trial testing Insole in Morton Neuroma in 72 participants. Completed in 31 March 2018.

Timeline
1 June 2015
Primary endpoint
31 March 2018
31 March 2018

Quick facts

Lead sponsorFederal University of São Paulo
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment72
Start date1 June 2015
Primary completion31 March 2018
Estimated completion31 March 2018

Drugs / interventions tested

Conditions studied

Sponsor

Federal University of São Paulo

Who can join

18 and older, any sex, with Morton Neuroma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objective: The aim of the present study was to assess the effectiveness of insole with metatarsal support on pain in patients with Morton's neuroma and the impact of this insole on function, load distribution in the plantar region, gait variables, quality of life and satisfaction with insole use. Methods: A randomized, controlled, double-blind, clinical trial with intent-to-treat analysis. Seventy-two patients with Morton's neuroma were randomly allocated into a study group and control group. One week following the baseline evaluation, the study group received insole with metatarsal support made of ethyl vinyl acetate and the control group received a flat insole of the same material, color and density. The groups were evaluated after 6, 12 and 24 weeks of insole use. The following assessment parameters employed: pain when walking and at rest (END); quality of life (SF-36); foot function (FFI and FHSQ); six-minute walk test (6MWT) and foot pressure analysis using the AM Cube FootWalk Pro program.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Insole

Trials testing the same drug.

Other recruiting trials for Morton Neuroma

Currently open trials in the same condition.

Other Federal University of São Paulo trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing