Insole on Morton's Neuroma

Morton Neuroma Clinical Trial

Official title:

Effectiveness of Insole on Morton's Neuroma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03511677
• Other study ID #: 20634013.9.0000.5505.
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: March 31, 2018

Study information

• Verified date: April 2018
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Morton Neuroma
• Neuroma

Intervention

Device:
• Insole
Customized insole
• Placebo Insole
Placebo flat insole

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain	Measured by visual analogue scale from 0 cm to 10 cm	Baseline, after 6, 12 and 24 weeks
Secondary	Change in function and foot health	Measured by Foot function index questionnaire	Baseline, after 6, 12 and 24 weeks
Secondary	Change in function, foot healt and quality of life	Measured by Foot Health Status questionnaire	Baseline, after 6, 12 and 24 weeks
Secondary	Change in function	Measured by the distance in the six minute walking test	Baseline, after 6, 12 and 24 weeks
Secondary	Quality of life	Measured by the Short Form -36 questionnaire	Baseline, after 6, 12 and 24 weeks