Efficacy Study of Botox to Treat Neuropathic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Postherpetic Neuralgia Nerve Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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botulinum toxin A

active treatment arm using botulinum toxin A max 200 U injected into the painful area using SC injections 2 cm apart

Group Type EXPERIMENTAL

botulinum toxin A

Intervention Type DRUG

Botulinum toxin A versus saline in parallel groups

placebo

saline injection with the same dosages injected using the same procedure as botulinum toxin A

Group Type PLACEBO_COMPARATOR

botulinum toxin A

Intervention Type DRUG

Botulinum toxin A versus saline in parallel groups

Interventions

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botulinum toxin A

Botulinum toxin A versus saline in parallel groups

Intervention Type DRUG

Other Intervention Names

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saline (placebo)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No