A Study to Characterize the Phenotype in Patients With Morton's Neuroma and to Explore the Effect of Local Administration of Xylocaine (Lidocaine)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-05-31

Brief Summary

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To characterize the phenotype in patients with Morton's neuroma and to explore the effect of local administration of Xylocaine (lidocaine)

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Detailed Description

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A randomised, double-blind, placebo-controlled, three-way cross-over single center study to characterize the phenotype in patients with Morton's Neuroma and to explore the effect of local administration of Xylocaine (lidocaine)

Conditions

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Morton's Neuroma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Xylocaine_1mg

1 injection of Xylocaine (1 mg/mL)

Group Type ACTIVE_COMPARATOR

Xylocaine

Intervention Type DRUG

1 mg/mL solution for injection

Xylocaine_10mg

1 injection of Xylocaine (10 mg/mL)

Group Type ACTIVE_COMPARATOR

Xylocaine

Intervention Type DRUG

10 mg/mL solution for injection

Placebo

1 injection of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

solution for injection

Interventions

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Xylocaine

1 mg/mL solution for injection

Intervention Type DRUG

Xylocaine

10 mg/mL solution for injection

Intervention Type DRUG

Placebo

solution for injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with a clinical diagnosis of Morton's neuroma with symptoms of at least 3 months duration in one foot (affected foot)
* Visual analogue scale (VAS) pain-score of = 40 mm in the painful foot at daily activities during the previous week (visit 1)