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Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial

This study has suspended participant recruitment.
(Further enrollment is pending analysis of another trial)
Sponsor:
Information provided by (Responsible Party):
Sean Mackey, Stanford University
ClinicalTrials.gov Identifier:
NCT00822926
First received: January 14, 2009
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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).


Condition Intervention
Pain
Drug: Botulinum Toxin Type A
Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Time to analgesic failure [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in area of allodynia and hyperalgesia [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
  • Improvement in psychosocial function as assessed by outcomes as dictated by the IMMPACT Guidelines [ Time Frame: Duration of Trial ] [ Designated as safety issue: No ]
  • Proportion of patients experiencing a reduction of 2 points or more on NRS, three weeks after injection, compared to baseline NRS [ Time Frame: 3 weeks after injection ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Saline
Subcutaneous injection of saline into scar tissue
Experimental: Botulinum Toxin Type A Drug: Botulinum Toxin Type A
Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Sean Mackey, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00822926     History of Changes
Other Study ID Numbers: SU-01072009-1499, 15601
Study First Received: January 14, 2009
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014