Skip to main content
OpenTrials
Completed

NCT Number: NCT03511677

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Morton Neuroma Foot Diseases Joint Diseases Metatarsalgia Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insole

Device

Customized insole

Placebo Insole

Device

Placebo flat insole

Primary outcomes

  1. Change in pain

    Time frame: Baseline, after 6, 12 and 24 weeks

    Measured by visual analogue scale from 0 cm to 10 cm

Secondary outcomes

  1. Change in function and foot health

    Time frame: Baseline, after 6, 12 and 24 weeks

    Measured by Foot function index questionnaire

  2. Change in function, foot healt and quality of life

    Time frame: Baseline, after 6, 12 and 24 weeks

    Measured by Foot Health Status questionnaire

  3. Change in function

    Time frame: Baseline, after 6, 12 and 24 weeks

    Measured by the distance in the six minute walking test

  4. Quality of life

    Time frame: Baseline, after 6, 12 and 24 weeks

    Measured by the Short Form -36 questionnaire

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

Effectiveness of Insole on Morton's Neuroma

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 30, 2018
Registry last updated
Apr 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.