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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Customized insole with metatarsal support |
|
| Control Group | Placebo Comparator | Placebo flat insole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insole | Device | Customized insole |
| |
| Placebo Insole |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain | Measured by visual analogue scale from 0 cm to 10 cm | Baseline, after 6, 12 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in function and foot health | Measured by Foot function index questionnaire | Baseline, after 6, 12 and 24 weeks |
| Change in function, foot healt and quality of life | Measured by Foot Health Status questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000070607 | Morton Neuroma |
| D010146 | Pain |
| ID | Term |
|---|---|
| D037061 | Metatarsalgia |
| D005534 | Foot Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D061826 | Foot Orthoses |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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Placebo insole
| Device |
Placebo flat insole |
|
| Baseline, after 6, 12 and 24 weeks |
| Change in function | Measured by the distance in the six minute walking test | Baseline, after 6, 12 and 24 weeks |
| Quality of life | Measured by the Short Form -36 questionnaire | Baseline, after 6, 12 and 24 weeks |
| D009437 |
| Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |