Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial - Full Text View

Sponsored by:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00822926

Purpose

Superficial injection of Botulinum toxin has been advocated for cosmetic purposes but has also been reported to be helpful for some pain conditions. We have observed prolonged profound analgesia following subcutaneous superficial injection of Botulinum Toxin Type A (BTA) in patients with certain types of neuropathic pain. We 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).

Condition	Intervention
Pain	Drug: Botulinum Toxin Type A

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial

Resource links provided by NLM:

MedlinePlus related topics: Botox

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Time to analgesic failure

Secondary Outcome Measures:

Reduction in area of allodynia and hyperalgesia
Improvement in psychosocial function as assessed by outcomes as dictated by the IMMPACT Guidelines
Proportion of patients experiencing a reduction of 2 points or more on NRS, three weeks after injection, compared to baseline NRS

Estimated Enrollment:	20
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

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 we 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822926

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:	Ian R Carroll	Stanford University
Principal Investigator:	Sean Mackey	Stanford University

More Information

No publications provided

Responsible Party:	Stanford University School of Medicine ( Sean Mackey, a Principal Investigator )
Study ID Numbers:	SU-01072009-1499, 15601
Study First Received:	January 14, 2009
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00822926 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Botulinum Toxins
Pain
Peripheral Nervous System Agents
Botulinum Toxin Type A

Additional relevant MeSH terms:

Botulinum Toxins
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Neuromuscular Agents

Peripheral Nervous System Agents
Botulinum Toxin Type A
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 01, 2009