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Insole on Morton's Neuroma

Primary Purpose

Morton Neuroma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Insole
Placebo Insole
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morton Neuroma focused on measuring Insole, Morton Neuroma, Pain, Function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Intervention Group

    Control Group

    Arm Description

    Customized insole with metatarsal support

    Placebo flat insole

    Outcomes

    Primary Outcome Measures

    Change in pain
    Measured by visual analogue scale from 0 cm to 10 cm

    Secondary Outcome Measures

    Change in function and foot health
    Measured by Foot function index questionnaire
    Change in function, foot healt and quality of life
    Measured by Foot Health Status questionnaire
    Change in function
    Measured by the distance in the six minute walking test
    Quality of life
    Measured by the Short Form -36 questionnaire

    Full Information

    First Posted
    April 17, 2018
    Last Updated
    April 26, 2018
    Sponsor
    Federal University of São Paulo
    Collaborators
    Conselho Nacional de Desenvolvimento Científico e Tecnológico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03511677
    Brief Title
    Insole on Morton's Neuroma
    Official Title
    Effectiveness of Insole on Morton's Neuroma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2015 (Actual)
    Primary Completion Date
    March 31, 2018 (Actual)
    Study Completion Date
    March 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of São Paulo
    Collaborators
    Conselho Nacional de Desenvolvimento Científico e Tecnológico

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Morton Neuroma
    Keywords
    Insole, Morton Neuroma, Pain, Function

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Placebo insole
    Allocation
    Randomized
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    Customized insole with metatarsal support
    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo flat insole
    Intervention Type
    Device
    Intervention Name(s)
    Insole
    Intervention Description
    Customized insole
    Intervention Type
    Device
    Intervention Name(s)
    Placebo Insole
    Intervention Description
    Placebo flat insole
    Primary Outcome Measure Information:
    Title
    Change in pain
    Description
    Measured by visual analogue scale from 0 cm to 10 cm
    Time Frame
    Baseline, after 6, 12 and 24 weeks
    Secondary Outcome Measure Information:
    Title
    Change in function and foot health
    Description
    Measured by Foot function index questionnaire
    Time Frame
    Baseline, after 6, 12 and 24 weeks
    Title
    Change in function, foot healt and quality of life
    Description
    Measured by Foot Health Status questionnaire
    Time Frame
    Baseline, after 6, 12 and 24 weeks
    Title
    Change in function
    Description
    Measured by the distance in the six minute walking test
    Time Frame
    Baseline, after 6, 12 and 24 weeks
    Title
    Quality of life
    Description
    Measured by the Short Form -36 questionnaire
    Time Frame
    Baseline, after 6, 12 and 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Insole on Morton's Neuroma

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