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

Neuropathic Pain Clinical Trial

— APTODON  

Official title:

Early Administration of Botulinum Toxin Type A (Botox®) in Neuropathic Pain Due to Thoracoscopy or Thoracotomy: a Randomized, Double Blind, Placebo Controlled Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01325090
• Other study ID #: I09006 / APTODON
• Secondary ID: 2010-021506-38
• Status: Withdrawn
• Phase: Phase 3
• Start date: May 2011
• Est. completion date: November 2014

Study information

• Verified date: March 2011
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• daily pain, for 3 months, secondary to thoracoscopy or thoracotomy, of neuropathic origin (DN4 questionary)

Exclusion Criteria:

• contraindications for botulinum toxin

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Pain Due to Certain Specified Procedures

Intervention

Drug:
• BOTOX
A syringe of 1 ml contain 25 Allergan units.

Other:
• PLACEBO
The pharmacist will fill syringes in tuberculins of 1 ml with injectable solution of sodium chloride of 0,9 %.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease in average pain intensity as measured by the Brief Pain Inventory (BPI)		one month
Secondary	VAS in the last 24 hours		24 hours
Secondary	Neuropathic Pain Inventory		6 months