Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial

NCT00822926 | Terminated Results

• 2 other identifiers: SU-01072009-149915601
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Time to Analgesic Failure

  Participants completed the Pain Numeric Rating Scale everyday after the injections. Outcome measure represents the number of days before pain returned to baseline levels.

  Duration of trial (2-20 months, depending on how long pain relief lasts)

Secondary Outcomes (2)

• Improvement in Psychosocial Function as Assessed by Outcomes as Dictated by the IMMPACT Guidelines

  Duration of trial (2-20 months, depending on how long pain relief lasts)

• NRS Score Three Weeks After Injection

  3 weeks after injection

Study Arms (2)

Placebo then Botox

EXPERIMENTAL

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

Drug: Botulinum Toxin Type A; Drug: Saline

Botox then Placebo

EXPERIMENTAL

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

Drug: Botulinum Toxin Type A; Drug: Saline

Interventions

Botulinum Toxin Type A DRUG

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

Botox then Placebo; Placebo then Botox

Saline DRUG

Subcutaneous injection of saline into scar tissue

Botox then Placebo; Placebo then Botox

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Sean Mackey, Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab
• Organization: Stanford University School of Medicine

smackey@stanford.edu

(650) 498-6477

Study Officials

• Ian R Carroll

  Stanford University

  PRINCIPAL INVESTIGATOR

• Sean Mackey

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 15, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 15, 2017
• Results First Posted: August 15, 2017

Record last verified: 2017-07

Locations

US (1)