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Subcutaneous Botulinum Toxin for Cutaneous Allodynia

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Botulinum Toxin A
Placebo - Saline
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:- Moderate to severe pain (greater than 4/10) of duration more than 6 months despite previous therapy.

  • The patient exhibits at least 80% pain relief following injection of local anesthetic subcutaneously into scar as assessed by change in NRS
  • The patient reports the presence of hyperalgesia, allodynia, dysesthesia, or hypoesthesia surrounding the scar
  • Age 18-100
  • Ability to read, write, and converse in English, provide informed consent, and follow study procedures

Exclusion Criteria:

  1. Any neuromuscular disorder such as myasthenia gravis, eaton lambert, muscular dystrophy
  2. Any ongoing legal action related to their pain
  3. Allergy to local anesthetics
  4. A current or history of any severe psychiatric disorder
  5. History of any adverse reaction to botulinum toxin
  6. History of botulism
  7. Untreated infection
  8. Coagulopathy
  9. Females - positive pregnancy test
  10. Surgery within the past 6 months at the site of the painful scar

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Placebo then Botox

Botox then Placebo

Arm Description

Outcomes

Primary Outcome Measures

Time Until Analgesic Failure
Participants made daily NRS reports via Palm Pilot, and "failure" was defined as (Pre-injection baseline NRS) - (Mean NRS for any 3 preceding days) ≤ 0; or 9 months

Secondary Outcome Measures

NRS Score Three Weeks After Injection
The NRS scores range from 0-100, where 0 indicated no pain and 100 indicated the worst pain.

Full Information

First Posted
July 28, 2008
Last Updated
October 23, 2017
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT00725322
Brief Title
Subcutaneous Botulinum Toxin for Cutaneous Allodynia
Official Title
Subcutaneous Botulinum Toxin for Cutaneous Allodynia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo then Botox
Arm Type
Experimental
Arm Title
Botox then Placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin A
Intervention Description
Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue
Intervention Type
Drug
Intervention Name(s)
Placebo - Saline
Intervention Description
Subcutaneous Saline injection given at site of scar neuroma
Primary Outcome Measure Information:
Title
Time Until Analgesic Failure
Description
Participants made daily NRS reports via Palm Pilot, and "failure" was defined as (Pre-injection baseline NRS) - (Mean NRS for any 3 preceding days) ≤ 0; or 9 months
Time Frame
Each participant was assessed for up to 224 days per intervention (injection) or until they returned to NRS baseline
Secondary Outcome Measure Information:
Title
NRS Score Three Weeks After Injection
Description
The NRS scores range from 0-100, where 0 indicated no pain and 100 indicated the worst pain.
Time Frame
Three weeks after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:- Moderate to severe pain (greater than 4/10) of duration more than 6 months despite previous therapy. The patient exhibits at least 80% pain relief following injection of local anesthetic subcutaneously into scar as assessed by change in NRS The patient reports the presence of hyperalgesia, allodynia, dysesthesia, or hypoesthesia surrounding the scar 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 A current or history of any severe psychiatric disorder History of any adverse reaction to botulinum toxin History of botulism Untreated infection Coagulopathy Females - positive pregnancy test Surgery within the past 6 months at the site of the painful scar
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian R Carroll
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sean Mackey
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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Subcutaneous Botulinum Toxin for Cutaneous Allodynia

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