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

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

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01325090
Acronym
APTODON
Enrollment
0
Registered
2011-03-29
Start date
2011-05-01
Completion date
2014-11-01
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic Pain, Pain Due to Certain Specified Procedures

Keywords

neuropathic pain due to thoracotomy, Neuropathic Pain Due to Thoracoscopy

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.

Interventions

DRUGBOTOX

A syringe of 1 ml contain 25 Allergan units.

OTHERPLACEBO

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

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* contraindications for botulinum toxin

Design outcomes

Primary

MeasureTime frame
decrease in average pain intensity as measured by the Brief Pain Inventory (BPI)one month

Secondary

MeasureTime frame
VAS in the last 24 hours24 hours
Neuropathic Pain Inventory6 months

Countries

France

Contacts

PRINCIPAL_INVESTIGATORDanièle RANOUX, MD

University Hospital, Limoges

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026