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

Study Overview
=================
Brief Summary
-----------------
To characterize the phenotype in patients with Morton's neuroma and to explore the effect of local administration of Xylocaine (lidocaine)

Detailed Description
-----------------
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)

Official Title
-----------------
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
-----------------
Morton's Neuroma

Intervention / Treatment
-----------------
* Drug: Xylocaine
* Drug: Xylocaine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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) Exclusion Criteria: Allergy to lidocaine Scars or other dermal conditions on the feet that may interfere with study procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Xylocaine_1mg<br>1 injection of Xylocaine (1 mg/mL) | Drug: Xylocaine<br>* 1 mg/mL solution for injection<br>|
| Active Comparator: Xylocaine_10mg<br>1 injection of Xylocaine (10 mg/mL) | Drug: Xylocaine<br>* 10 mg/mL solution for injection<br>|
| Placebo Comparator: Placebo<br>1 injection of placebo | Drug: Placebo<br>* solution for injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The baseline phenotypic Quantitative sensory testing (QST) variables (e.g. heat, cold, touch and mechanical pain perception). Sensory tests will be performed to measure pain and skin sensitivity by use of different pressure (mN) and temperature ( C) |  | Before and after drug injection at Day 1 | 
| The baseline phenotypic Quantitative sensory testing (QST) variables (e.g. heat, cold, touch and mechanical pain perception). Sensory tests will be performed to measure pain and skin sensitivity by use of different pressure (mN) and temperature ( C) |  | Before and after drug injection at Day 14 (+/-9). | 
| The baseline phenotypic Quantitative sensory testing (QST) variables (e.g. heat, cold, touch and mechanical pain perception). Sensory tests will be performed to measure pain and skin sensitivity by use of different pressure (mN) and temperature ( C) |  | Before and after drug injection at Day 28 (+/-18). | 
| The effect of Xylocaine compared to placebo in QST variables. Sensory tests will be performed to measure pain and skin sensitivity by use of different pressure (mN) and temperature ( C) |  | After drug injection at Day 1. | 
| The effect of Xylocaine compared to placebo in QST variables. Sensory tests will be performed to measure pain and skin sensitivity by use of different pressure (mN) and temperature ( C) |  | After drug injection at Day 14 (+/-9). | 
| The effect of Xylocaine compared to placebo in QST variables. Sensory tests will be performed to measure pain and skin sensitivity by use of different pressure (mN) and temperature ( C) |  | After drug injection at Day 28 (+/-18). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency/severity of adverse events |  | Day 1 | 
| Frequency/severity of adverse events |  | Day 14 (+/-9) | 
| Frequency/severity of adverse events |  | Day 28 (+/-18) | 
| Frequency/severity of adverse events |  | Day 43 (+/-32) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Morton's neuroma, QST measurements