search
Back to results

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

Primary Purpose

Pain Due to Certain Specified Procedures, Neuropathic Pain

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
BOTOX
PLACEBO
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain Due to Certain Specified Procedures focused on measuring neuropathic pain due to thoracotomy, Neuropathic Pain Due to Thoracoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • contraindications for botulinum toxin

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    BOTOX

    PLACEBO

    Arm Description

    Patients will receive in one session multiple intradermal injections of Botox, in order to cover the whole painful area

    Patients will receive in one session multiple intradermal injections of placebo , in order to cover the whole painful area

    Outcomes

    Primary Outcome Measures

    decrease in average pain intensity as measured by the Brief Pain Inventory (BPI)

    Secondary Outcome Measures

    VAS in the last 24 hours
    Neuropathic Pain Inventory

    Full Information

    First Posted
    March 28, 2011
    Last Updated
    August 10, 2018
    Sponsor
    University Hospital, Limoges
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01325090
    Brief Title
    Early Administration of Botox® in Neuropathic Pain Due to Thoracoscopy or Thoracotomy
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2011
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    May 2011 (Actual)
    Primary Completion Date
    November 2013 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Limoges

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain Due to Certain Specified Procedures, Neuropathic Pain
    Keywords
    neuropathic pain due to thoracotomy, Neuropathic Pain Due to Thoracoscopy

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BOTOX
    Arm Type
    Experimental
    Arm Description
    Patients will receive in one session multiple intradermal injections of Botox, in order to cover the whole painful area
    Arm Title
    PLACEBO
    Arm Type
    Placebo Comparator
    Arm Description
    Patients will receive in one session multiple intradermal injections of placebo , in order to cover the whole painful area
    Intervention Type
    Drug
    Intervention Name(s)
    BOTOX
    Intervention Description
    A syringe of 1 ml contain 25 Allergan units.
    Intervention Type
    Other
    Intervention Name(s)
    PLACEBO
    Intervention Description
    The pharmacist will fill syringes in tuberculins of 1 ml with injectable solution of sodium chloride of 0,9 %.
    Primary Outcome Measure Information:
    Title
    decrease in average pain intensity as measured by the Brief Pain Inventory (BPI)
    Time Frame
    one month
    Secondary Outcome Measure Information:
    Title
    VAS in the last 24 hours
    Time Frame
    24 hours
    Title
    Neuropathic Pain Inventory
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Danièle RANOUX, MD
    Organizational Affiliation
    University Hospital, Limoges
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs