Insole on Morton's Neuroma

April 26, 2018 updated by: Hilda Alcantara Veiga de Oliveira, Federal University of São Paulo

Effectiveness of Insole on Morton's Neuroma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Customized insole with metatarsal support
Device: Insole
Customized insole
Placebo Comparator: Control Group
Placebo flat insole
Device: Placebo Insole
Placebo flat insole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain
Time Frame: Baseline, after 6, 12 and 24 weeks
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
Time Frame: Baseline, after 6, 12 and 24 weeks
Measured by Foot function index questionnaire
Baseline, after 6, 12 and 24 weeks
Change in function, foot healt and quality of life
Time Frame: Baseline, after 6, 12 and 24 weeks
Measured by Foot Health Status questionnaire
Baseline, after 6, 12 and 24 weeks
Change in function
Time Frame: Baseline, after 6, 12 and 24 weeks
Measured by the distance in the six minute walking test
Baseline, after 6, 12 and 24 weeks
Quality of life
Time Frame: Baseline, after 6, 12 and 24 weeks
Measured by the Short Form -36 questionnaire
Baseline, after 6, 12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

March 31, 2018

Study Completion (Actual)

March 31, 2018

Study Registration Dates

First Submitted

April 17, 2018

First Submitted That Met QC Criteria

April 26, 2018

First Posted (Actual)

April 30, 2018

Study Record Updates

Last Update Posted (Actual)

April 30, 2018

Last Update Submitted That Met QC Criteria

April 26, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20634013.9.0000.5505.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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