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)
18 Years
80 Years
Both
Morton's Neuroma
Trial Information
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)
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)
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Outcome Measure:
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)
Outcome Time Frame:
Before and after drug injection at Day 1
Safety Issue:
No
Principal Investigator
Bror Jonzon, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca R&D Södertälje, Sweden
Authority:
Sweden: Medical Products Agency
Study ID:
D2285M00032
NCT ID:
NCT01298310
Start Date:
February 2011
Completion Date:
May 2012
Related Keywords:
- Morton's Neuroma
- Morton's neuroma, QST measurements
- Neuroma
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