Morton Neuroma
Conditions
Keywords
Insole, Morton Neuroma, Pain, Function
Brief 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.
Interventions
DEVICEInsole
Customized insole
DEVICEPlacebo Insole
Placebo flat insole
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Placebo insole
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with clinical and radiological diagnosis (magnetic resonance or ultrasound) of Morton's neuroma. * Pain in the foot with VAS between 3-8 cm to walk. * Over 18 years. * No distinction of sex * Agree to participate of the study and sign the informed consent form.
Exclusion criteria
* Other symptomatic musculoskeletal diseases in MMII. * Symptomatic diseases of the central and peripheral nervous system. * Diabetes Mellitus. * Rigid deformities on foot. * Use of insoles in the last three months. * Physiotherapy in the last three months. * Infiltrations on foot and ankles in the last three months. * Previous or expected surgery in the next twelve months. * Allergy to the material of the insole. * Mental deficiency. * Geographic inaccessibility .- Use of corticosteroids or NSAIDs in the last month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain | Baseline, after 6, 12 and 24 weeks | Measured by visual analogue scale from 0 cm to 10 cm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in function and foot health | Baseline, after 6, 12 and 24 weeks | Measured by Foot function index questionnaire |
| Change in function, foot healt and quality of life | Baseline, after 6, 12 and 24 weeks | Measured by Foot Health Status questionnaire |
| Change in function | Baseline, after 6, 12 and 24 weeks | Measured by the distance in the six minute walking test |
| Quality of life | Baseline, after 6, 12 and 24 weeks | Measured by the Short Form -36 questionnaire |
Outcome results
None listed