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Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00822926
First Posted: January 15, 2009
Last Update Posted: August 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sean Mackey, Stanford University
January 14, 2009
January 15, 2009
April 17, 2017
August 15, 2017
August 15, 2017
January 2009
December 2013   (Final data collection date for primary outcome measure)
Time to Analgesic Failure [ Time Frame: Duration of trial (2-20 months, depending on how long pain relief lasts) ]
Participants completed the Pain Numeric Rating Scale everyday after the injections. Outcome measure represents the number of days before pain returned to baseline levels.
Time to Analgesic Failure
Complete list of historical versions of study NCT00822926 on ClinicalTrials.gov Archive Site
  • Improvement in Psychosocial Function as Assessed by Outcomes as Dictated by the IMMPACT Guidelines [ Time Frame: Duration of trial (2-20 months, depending on how long pain relief lasts) ]
    The Beck Depression Inventory was used to assess psychosocial function. Scores were measured at baseline, their final questionnaire following the first injection visit, and their final questionnaire following their second injection visit. Scores range from 0-63, with lower scores representing less severe depression symptoms and higher scores representing more severe depression symptoms.
  • NRS Score Three Weeks After Injection [ Time Frame: 3 weeks after injection ]
    Pain scores were measured at baseline, 3 weeks after placebo, and 3 weeks after botox. Scores range from 0 (no pain) to 10 (severe, disabling pain).
  • Reduction in area of allodynia and hyperalgesia
  • mprovement 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
Not Provided
Not Provided
 
Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial
Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial
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).

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pain
  • Drug: Botulinum Toxin Type A
    Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
  • Drug: Saline
    Subcutaneous injection of saline into scar tissue
  • Experimental: 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
    Interventions:
    • Drug: Botulinum Toxin Type A
    • Drug: Saline
  • Experimental: 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
    Interventions:
    • Drug: Botulinum Toxin Type A
    • Drug: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
December 2013
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00822926
SU-01072009-1499
15601
Not Provided
Not Provided
Not Provided
Sean Mackey, Stanford University
Stanford University
Not Provided
Principal Investigator: Ian R Carroll Stanford University
Principal Investigator: Sean Mackey Stanford University
Stanford University
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP