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Early Administration of Botox® in Neuropathic Pain Due to Thoracoscopy or Thoracotomy

Phase 3
Withdrawn
Conditions
Pain Due to Certain Specified Procedures
Neuropathic Pain
Interventions
Other: PLACEBO
Registration Number
NCT01325090
Lead Sponsor
University Hospital, Limoges
Brief Summary

Botulinum toxin type A has been reported to inhibit the release of various pain neurotransmitters (SP, CGRP, glutamate) responsible for neurogenic inflammation, a process that results from the sensitization of C-fiber nociceptors (peripheral sensitization). This action is probably responsible for the analgesic effect of botulinum toxin type A recently demonstrated in patients with neuropathic pain of peripheral origin.In those studies, patients had been suffering for years. The investigators can hypothesizes that earlier administration of Botox in the course of neuropathic pain might prevent central sensitization, that is secondary to peripheral sensitization. The investigators can hope to increase efficacy of Botulinum toxin type A injections and to prevent chronification of pain.

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • daily pain, for 3 months, secondary to thoracoscopy or thoracotomy, of neuropathic origin (DN4 questionary)
Exclusion Criteria
  • contraindications for botulinum toxin

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
BOTOXBOTOXPatients will receive in one session multiple intradermal injections of Botox, in order to cover the whole painful area
PLACEBOPLACEBOPatients will receive in one session multiple intradermal injections of placebo , in order to cover the whole painful area
Primary Outcome Measures
NameTimeMethod
decrease in average pain intensity as measured by the Brief Pain Inventory (BPI)one month
Secondary Outcome Measures
NameTimeMethod
VAS in the last 24 hours24 hours
Neuropathic Pain Inventory6 months

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