Early Administration of Botulinum Toxin Type A (Botox®) in Neuropathic Pain Due to Thoracoscopy or Thoracotomy: a Randomized, Double Blind, Placebo Controlled Study
Overview
- Phase
- Phase 3
- Intervention
- BOTOX
- Conditions
- Pain Due to Certain Specified Procedures
- Sponsor
- University Hospital, Limoges
- Primary Endpoint
- decrease in average pain intensity as measured by the Brief Pain Inventory (BPI)
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •daily pain, for 3 months, secondary to thoracoscopy or thoracotomy, of neuropathic origin (DN4 questionary)
Exclusion Criteria
- •contraindications for botulinum toxin
Arms & Interventions
BOTOX
Patients will receive in one session multiple intradermal injections of Botox, in order to cover the whole painful area
Intervention: BOTOX
PLACEBO
Patients will receive in one session multiple intradermal injections of placebo , in order to cover the whole painful area
Intervention: PLACEBO
Outcomes
Primary Outcomes
decrease in average pain intensity as measured by the Brief Pain Inventory (BPI)
Time Frame: one month
Secondary Outcomes
- VAS in the last 24 hours(24 hours)
- Neuropathic Pain Inventory(6 months)