NCT00725322

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

October 25, 2017

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

5.3 years

First QC Date

July 28, 2008

Results QC Date

July 11, 2017

Last Update Submit

October 23, 2017

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • 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

    Each participant was assessed for up to 224 days per intervention (injection) or until they returned to NRS baseline

Secondary Outcomes (1)

  • NRS Score Three Weeks After Injection

    Three weeks after injection

Study Arms (2)

Placebo then Botox

EXPERIMENTAL
Drug: Placebo - Saline

Botox then Placebo

EXPERIMENTAL
Drug: Botulinum Toxin A

Interventions

Botulinum Toxin ADRUG

Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue

Botox then Placebo
Placebo - SalineDRUG

Subcutaneous Saline injection given at site of scar neuroma

Placebo then Botox

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

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
Assistant Professor

Study Record Dates

First Submitted

July 28, 2008

First Posted

July 30, 2008

Study Start

December 1, 2007

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

October 25, 2017

Results First Posted

October 25, 2017

Record last verified: 2017-10

Locations

US(1)