Insole on Morton's Neuroma

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Insole on Morton's Neuroma

Conditions
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Morton Neuroma

Intervention / Treatment
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* Device: Insole
* Device: Placebo Insole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Customized insole with metatarsal support | Device: Insole<br>* Customized insole<br>|
| Placebo Comparator: Control Group<br>Placebo flat insole | Device: Placebo Insole<br>* Placebo flat insole<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insole, Morton Neuroma, Pain, Function