NCT03511677

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 30, 2018

Completed
Last Updated

April 30, 2018

Status Verified

April 1, 2018

Enrollment Period

2.8 years

First QC Date

April 17, 2018

Last Update Submit

April 26, 2018

Conditions

Morton Neuroma

Keywords

InsoleMorton NeuromaPainFunction

Outcome Measures

Primary Outcomes (1)

  • Change in pain

    Measured by visual analogue scale from 0 cm to 10 cm

    Baseline, after 6, 12 and 24 weeks

Secondary Outcomes (4)

  • Change in function and foot health

    Baseline, after 6, 12 and 24 weeks

  • Change in function, foot healt and quality of life

    Baseline, after 6, 12 and 24 weeks

  • Change in function

    Baseline, after 6, 12 and 24 weeks

  • Quality of life

    Baseline, after 6, 12 and 24 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Customized insole with metatarsal support

Device: Insole

Control Group

PLACEBO COMPARATOR

Placebo flat insole

Device: Placebo Insole

Interventions

InsoleDEVICE

Customized insole

Intervention Group
Placebo InsoleDEVICE

Placebo flat insole

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Morton NeuromaPain

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

MetatarsalgiaFoot DiseasesMusculoskeletal DiseasesJoint DiseasesNeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Placebo insole
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, MsC

Study Record Dates

First Submitted

April 17, 2018

First Posted

April 30, 2018

Study Start

June 1, 2015

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

April 30, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share