Insole on Morton's Neuroma

Not Applicable

Completed

• Conditions: Morton Neuroma
• Interventions: Device: Placebo Insole; Device: Insole

• Registration Number: NCT03511677
• Lead Sponsor: Federal University of São Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-01
• Primary Completion: 2018-03-31
• Study Completion: 2018-03-31
• Status Verified: 2018-04
• Study First Submitted: 2018-04-17
• Study First Submitted QC: 2018-04-26
• Last Update Submitted: 2018-04-26
• Study First Posted: 2018-04-30
• Last Update Posted: 2018-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo Insole	Placebo flat insole
Intervention Group	Insole	Customized insole with metatarsal support

Primary Outcome Measures

Name	Time	Method
Change in pain	Baseline, after 6, 12 and 24 weeks	Measured by visual analogue scale from 0 cm to 10 cm

Secondary Outcome Measures

Name	Time	Method
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