Botulinum Toxin in Peripheral Neuropathic Pain
- Conditions
- Postherpetic NeuralgiaDiabetic PolyneuropathiesOther Polyneuropathies
- Interventions
- Registration Number
- NCT01251211
- Lead Sponsor
- Hospital Ambroise Paré Paris
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Men or women aged 18 to 85 years Spontaneous pain with a minimal intensity of 4/10 on numerical scle Pain present for at least 6 months Pain related to painful mononeuropathy or sensory polyneuropathy Able to understand the protocol and comply to the requirements of the study Written informed consent Painful area limited to a maximum of 240 cm2
Facial pain Litigation (pending) Unstable condition responsible for neuropathic pain (ie, unstable immunological disease...) HIV or chemotherapy induced neuropathy Contraindications to BTX-A (neuromuscular disease, hypersensitivity, infection, coagulation disorder, pregnancy) Other pain more severe than neuropathic pain No compliance with the self diary Drug abuse or alcoholism Severe major depression Cognitive impairment Other research protocol within the last 30 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description botulinum toxin type A botulinum toxin type A botulinum toxin type A will be injected subcutaneously in the painful area (maximum 300 units) sodium chloride 9 % botulinum toxin type A sodium chloride 9 % will be used as a neutral placebo
- Primary Outcome Measures
Name Time Method Average pain intensity on numerical scales in a self diary by the patient every day from baseline for up to 6 months Numerical scales (0-10)
- Secondary Outcome Measures
Name Time Method Efficacy of treatment on neuropathic symptoms at each visit Neuropathic Pain Symptom Inventory will be used to assess symptoms
Quality of life VAS at each visit This will be assessed using the EuroQol questionnaire
Intensity of allodynia to brush at each visit This will performed using a brush
assessment of effects of BTX-A on substance P and CGRP at baseline and 1 month after BTX-A or placebo This will be performed using skin punch biopsies in the painful area
Side effects throughout the study and each each visit side effects of BTX-A will be assessed
Detection and pain thresholds to mechanical and thermal stimuli and responses to suprathreshold stimuli at each visit this will use quantitative sensory testing (thermotest, Von Frey filaments)
Predictors of the response Up to 6 months 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
Trial Locations
- Locations (3)
Divisão de Clínica Neurológica do Hospital das Clínicas da FMUSP
🇧🇷Sao Paulo, Brazil
Hôpital Ambroise Paré, APHP
🇫🇷Boulogne-Billancourt, France
Hôpital Dupuytren
🇫🇷Limoges, France
Divisão de Clínica Neurológica do Hospital das Clínicas da FMUSP🇧🇷Sao Paulo, Brazil