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Insole on Morton's Neuroma

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ClinicalTrials.gov Identifier: NCT03511677
Recruitment Status : Completed
First Posted : April 30, 2018
Last Update Posted : April 30, 2018
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Hilda Alcantara Veiga de Oliveira, Federal University of São Paulo

Study Description
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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.


Condition or disease Intervention/treatment Phase
Morton Neuroma Device: Insole Device: Placebo Insole Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Placebo insole
Primary Purpose: Treatment
Official Title: Effectiveness of Insole on Morton's Neuroma
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : March 31, 2018
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Hilda Alcantara Veiga de Oliveira, PT, MsC, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT03511677    
Other Study ID Numbers: 20634013.9.0000.5505.
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hilda Alcantara Veiga de Oliveira, Federal University of São Paulo:
Insole
Morton Neuroma
Pain
Function
Additional relevant MeSH terms:
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Neuroma
Morton Neuroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Metatarsalgia
Foot Diseases
 Musculoskeletal Diseases
Joint Diseases
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations