Efficacy Study of Botox to Treat Neuropathic Pain

Phase 4

Completed

• Conditions: Postherpetic Neuralgia; Nerve Trauma
• Interventions: Drug: botulinum toxin A

• Registration Number: NCT00527202
• Lead Sponsor: Hospital Ambroise Paré Paris

Brief Summary

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)

Detailed Description

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.

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Study First Submitted: 2007-09-07
• Study First Submitted QC: 2007-09-07
• Study First Posted: 2007-09-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	botulinum toxin A	saline injection with the same dosages injected using the same procedure as botulinum toxin A
botulinum toxin A	botulinum toxin A	active treatment arm using botulinum toxin A max 200 U injected into the painful area using SC injections 2 cm apart

Primary Outcome Measures

Name	Time	Method
Self-reported pain (numerical scales) on patients diaries	prospective	pain intensity on numerical rating scales

Secondary Outcome Measures

Name	Time	Method
mean pain (VAS) at each visit Quality of life Proportion of responders % pain relief Clinical global impression Assessment of blindedness	prospective	VAS for pain intensity

Trial Locations

Locations (1)

Hôpital Ambroise Paré, AP-HP; 🇫🇷 Boulogne-billancourt, France