Morton's Neuroma
Conditions
Keywords
Morton's neuroma, QST measurements
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)
Interventions
DRUGXylocaine
1 mg/mL solution for injection
DRUGPlacebo
solution for injection
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 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. |
Secondary
| Measure | Time frame |
|---|---|
| Frequency/severity of adverse events | Day 1 |
Countries
Sweden
Outcome results
None listed