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

This study is not yet open for participant recruitment.
Verified March 2011 by University Hospital, Limoges
Sponsor:
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01325090
First received: March 28, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Pain Due to Certain Specified Procedures
Neuralgia
 Drug: BOTOX
Other: PLACEBO
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
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

Resource links provided by NLM:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • decrease in average pain intensity as measured by the Brief Pain Inventory (BPI) [ Time Frame: one month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VAS in the last 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Neuropathic Pain Inventory [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: May 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BOTOX
Patients will receive in one session multiple intradermal injections of Botox, in order to cover the whole painful area
 Drug: BOTOX
A syringe of 1 ml contain 25 Allergan units.
Placebo Comparator: PLACEBO
Patients will receive in one session multiple intradermal injections of placebo , in order to cover the whole painful area
 Other: PLACEBO
The pharmacist will fill syringes in tuberculins of 1 ml with injectable solution of sodium chloride of 0,9 %.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • contraindications for botulinum toxin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325090

Contacts
Contact: Danièle RANOUX, MD 0555056231

Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Danièle RANOUX, MD University Hospital, Limoges
  More Information

No publications provided

Responsible Party: Marie SENGELEN / Directrice de la Recherche et de l'Innovation, CHU de Limoges
ClinicalTrials.gov Identifier: NCT01325090     History of Changes
Other Study ID Numbers: I09006 / APTODON, 2010-021506-38
Study First Received: March 28, 2011
Last Updated: March 28, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Limoges:
neuropathic pain due to thoracotomy
Neuropathic Pain Due to Thoracoscopy

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Signs and Symptoms
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013