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OpenTrials
Completed

NCT Number: NCT00527202

Efficacy Study of Botox to Treat Neuropathic Pain

Objectives : to investigate the analgesic effects and safety of intradermal botulinum toxin A injection in the treatment of focal painful neuropathies (eg, postherpetic neuralgia, nerve trauma)

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Key information

Conditions

Postherpetic Neuralgia Nerve Trauma Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital Ambroise Paré, AP-HP

Boulogne-Billancourt, 92100f, France

About this study

The study will be randomized, performed in parallel group and double blind versus saline and will include 30 patients. Botulinum toxin injection will be injected intradermally in the painful area (one single injection) following a method adapted from that used in hyperhidrosis. The patients will be followed for 6 months after the injection. Primary outcome will be self-reported pain from the patients diaries. Secondary outcomes will be neuropathic symptoms, quality of life, allodynia to brush and pressure, detection and pain thresholds, proportion of responders, pain relief and clinical global impression. Clinical assessment will take place before injection then at 1 month, 3 months and 6 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • daily pain for at least 6 months of at least moderate intensity clearly attributed to the nerve lesion
  • limited area of pain
  • mechanical allodynia in the painful area

Exclusion criteria

  • contraindication to BTXA formulation
  • coagulation disorders
  • another painful condition
  • current major depression
  • history of drug or alcohol abuse
  • compensation claim or litigation
  • facial neuropathic pain

Treatment and study plan

Botulinum toxin A

Drug

Botulinum toxin A versus saline in parallel groups

Other names: saline (placebo)

Primary outcomes

  1. Self-reported pain (numerical scales) on patients diaries

    Time frame: prospective

    pain intensity on numerical rating scales

Secondary outcomes

  1. mean pain (VAS) at each visit Quality of life Proportion of responders % pain relief Clinical global impression Assessment of blindedness

    Time frame: prospective

    VAS for pain intensity

Sponsors and collaborators

Lead sponsor

Hospital Ambroise Paré Paris

Other

Registry information

Official study title

Randomized Placebo-controlled Study of the Efficacy of Botulinum Toxin Type A (Botox) in Spontaneous Pain and Allodynia Related to Traumatic Nerve Injury or Postherpetic Neuralgia

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 10, 2007
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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