Pain due to peripheral nerve lesion remains extremely difficult to treat and current treatments have onl moderate efficacy and/or side effects. The investigators have previously demonstrated the long term efficacy of Botulinum toxin type A (BTX-A) in a small group of patients with post-traumatic/postherpetic neuralgia and allodynia. The present study aims to a/ confirm the efficacy of repeated applications of BTX-A in a larger group of patients with peripheral neuropathic pain with or without allodynia(primary outcome) ; b/ evaluate its mechanisms of action ; c/analyse the predictors of response ;d/analyse whether the second injection is associated with a therapeutic gain. This will be a randomized placebo controlled study. A total of 30 patients will be randomized to receive either BTX-A (subcutaneous injection in the painful area) or placebo. Each injection will be repeated within at least 3 months depending on the duration of efficacy. Skin punch biopsies will be performed before and 1 month after BTX-A administration. The investigators postulate that this study will confirm the clinical efficacy and good safety of repeated administrations of BTX-A in the treatment of peripheral neuropathic pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
66
BTX A : 5 units/0.2 ml, maximum 300 units will be injected subcutaneous in the painful area ; this will be performed after randomization and within a minimum of 3 months interval depending on the duration of efficacy (maximum 6 months) Saline will be injected in the same volume in the painful area within the same frequency
Divisão de Clínica Neurológica do Hospital das Clínicas da FMUSP
São Paulo, São Paulo, Brazil
Hôpital Ambroise Paré, APHP
Boulogne-Billancourt, France
Hôpital Dupuytren
Limoges, France
Average pain intensity on numerical scales in a self diary by the patient
Numerical scales (0-10)
Time frame: every day from baseline for up to 6 months
Efficacy of treatment on neuropathic symptoms
Neuropathic Pain Symptom Inventory will be used to assess symptoms
Time frame: at each visit
Quality of life VAS
This will be assessed using the EuroQol questionnaire
Time frame: at each visit
Intensity of allodynia to brush
This will performed using a brush
Time frame: at each visit
assessment of effects of BTX-A on substance P and CGRP
This will be performed using skin punch biopsies in the painful area
Time frame: at baseline and 1 month after BTX-A or placebo
Side effects
side effects of BTX-A will be assessed
Time frame: throughout the study and each each visit
Detection and pain thresholds to mechanical and thermal stimuli and responses to suprathreshold stimuli
this will use quantitative sensory testing (thermotest, Von Frey filaments)
Time frame: at each visit
Predictors of the response
We will assess the predictors of the response to BTX-A based on baseline pain thresholds, presence and severity of allodynia, skin punch biopsy and catastrophizing
Time frame: Up to 6 months
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