Insole on Morton's Neuroma

Federal University of São Paulo

Status: Completed

Conditions: Morton Neuroma

Treatments: Device: Insole; Device: Placebo Insole

Study type: Interventional

Funder types: Other

Identifiers

NCT03511677

20634013.9.0000.5505.

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

72 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

Description:

Customized insole with metatarsal support

Treatment:

Device: Insole

Control Group

Placebo Comparator group

Description:

Placebo flat insole

Treatment:

Device: Placebo Insole