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Subcutaneous Botulinum Toxin for Cutaneous Allodynia

NCT ID: NCT00725322

Last Updated: 2017-10-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2013-03-31

Brief Summary

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Superficial injection of Botulinum toxin has been advocated for cosmetic purposes but has also been reported to be helpful for some pain conditions. The investigators have observed prolonged profound analgesia following subcutaneous superficial injection of Botulinum Toxin Type A (BTA) in patients with certain types of neuropathic pain. The investigators propose to study if addition of BTA extends pain relief compared to placebo when injected subcutaneously into areas of cutaneous allodynia (the property that a normally non-noxious stimulus is perceived as painful).

Detailed Description

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Post-surgical neuromatous pain patients have marked cutaneous allodynia. Touching their skin with normally non-painful stimuli results in pain. Injected local anesthetics are often effective in providing temporary relief. In the course of clinical practice the investigators have observed that a number of patients with cutaneous allodynia have had marked persistent benefit from subcutaneous injection of Botulinum toxin Type A.

Rather than killing targeted neurons, Botulinum toxin type A inhibits release of acetylcholine from cholinergic nerve terminals in a prolonged but ultimately reversible manner. Neuropathic pain and its hallmark allodynia are classically difficult to treat. Standard treatment with tricyclic antidepressants, anti-epileptic drugs, opiates and spinal cord stimulation is frequently disappointing leaving patients with refractory pain. Surgical or percutaneous ablation of involved nerves has fallen out of favor among many due to disappointing results.

A pilot study is needed to assess the efficacy of superficially injected Botulinum Toxin type A for treatment of cutaneous allodynia and spontaneous pain among patients with neuropathic pain.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Placebo then Botox

Group Type EXPERIMENTAL

Placebo - Saline

Intervention Type DRUG

Subcutaneous Saline injection given at site of scar neuroma

Botox then Placebo

Group Type EXPERIMENTAL

Botulinum Toxin A

Intervention Type DRUG

Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue

Interventions

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Botulinum Toxin A

Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue

Intervention Type DRUG

Placebo - Saline

Subcutaneous Saline injection given at site of scar neuroma

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The patient exhibits at least 80% pain relief following injection of local anesthetic subcutaneously into scar as assessed by change in NRS
* The patient reports the presence of hyperalgesia, allodynia, dysesthesia, or hypoesthesia surrounding the scar
* Age 18-100
* Ability to read, write, and converse in English, provide informed consent, and follow study procedures

Exclusion Criteria

1. Any neuromuscular disorder such as myasthenia gravis, eaton lambert, muscular dystrophy
2. Any ongoing legal action related to their pain
3. Allergy to local anesthetics
4. A current or history of any severe psychiatric disorder
5. History of any adverse reaction to botulinum toxin
6. History of botulism
7. Untreated infection
8. Coagulopathy
9. Females - positive pregnancy test
10. Surgery within the past 6 months at the site of the painful scar
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Sean Mackey

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ian R Carroll

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Sean Mackey

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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11830

Identifier Type: -

Identifier Source: secondary_id

SU-01072008-965

Identifier Type: -

Identifier Source: org_study_id