Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial

NCT ID: NCT00822926

Last Updated: 2017-08-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2013-12-31

Brief Summary

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

Patients with post-herpetic neuralgia, complex regional pain syndrome, and 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

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Placebo then Botox

Injection 1: Saline- Subcutaneous injection of saline into scar tissue Injection 2: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue

Group Type: EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type: DRUG

Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue

Saline

Intervention Type: DRUG

Subcutaneous injection of saline into scar tissue

Botox then Placebo

Injection 1: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue Injection 2: Saline- Subcutaneous injection of saline into scar tissue

Group Type: EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type: DRUG

Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue

Saline

Intervention Type: DRUG

Subcutaneous injection of saline into scar tissue

Interventions

Botulinum Toxin Type A

Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue

Intervention Type: DRUG

Saline

Subcutaneous injection of saline into scar tissue

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Moderate to severe pain (greater than 2/10) of duration more than 6 months despite previous therapy, excluding botox injection
• The patient exhibits at least 80% pain relief following injection of local anesthetic subcutaneously into scar as assessed by change in NRS
• Patient reports more than 3 weeks of greater than 50% pain relief from previous botox injection
• The patient reports the presence of hyperalgesia, allodynia, dysesthesia, or hypoesthesia surrounding the scar in the absence of the botox injection
• Age 18-100
• Ability to read, write, and converse in English, provide informed consent, and follow study procedures

Exclusion Criteria

• Any neuromuscular disorder such as myasthenia gravis, eaton lambert, muscular dystrophy
• Any ongoing legal action related to their pain
• Allergy to local anesthetics
• Any ongoing disability claim
• Currently being treated for any severe psychiatric disorder, including anxiety or depression
• History of any adverse reaction to botulinum toxin
• History of botulism
• Untreated infection
• Coagulopathy
• (Females) - positive pregnancy test
• Surgery in the last 6 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Sean Mackey

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ian R Carroll

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Sean Mackey

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

15601

Identifier Type: -

Identifier Source: secondary_id

SU-01072009-1499

Identifier Type: -

Identifier Source: org_study_id