Insole on Morton's Neuroma
Primary Purpose
Morton Neuroma
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Insole
Placebo Insole
Sponsored by
About this trial
This is an interventional treatment trial for Morton Neuroma focused on measuring Insole, Morton Neuroma, Pain, Function
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
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
NCT ID
NCT03511677
First Posted
April 17, 2018
Last Updated
April 26, 2018
Sponsor
Federal University of São Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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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