Trials / Completed
CompletedNCT03511677
Insole on Morton's Neuroma
Effectiveness of Insole on Morton's Neuroma
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Federal University of São Paulo · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Insole | Customized insole |
| DEVICE | Placebo Insole | Placebo flat insole |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2018-03-31
- Completion
- 2018-03-31
- First posted
- 2018-04-30
- Last updated
- 2018-04-30
Source: ClinicalTrials.gov record NCT03511677. Inclusion in this directory is not an endorsement.