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Botulinum Toxin Type A for Neuroma Pain

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.
 
ClinicalTrials.gov Identifier: NCT01374191
Recruitment Status : Withdrawn
First Posted : June 15, 2011
Last Update Posted : August 26, 2015
Sponsor:
Information provided by (Responsible Party):
Southern Illinois University

Tracking Information
First Submitted Date  ICMJE June 13, 2011
First Posted Date  ICMJE June 15, 2011
Last Update Posted Date August 26, 2015
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2011)
number of pain-free days [ Time Frame: change from baseline to 28 days ]
subjective evaluation of pain relief, using Subjective pain scales [visual analogue scale (VAS) and faces pain assessment]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01374191 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2011)
  • quality of life [ Time Frame: change from baseline to 28 days ]
    SF-12v2® Health Survey - Pain Enhanced
  • upper extremity function [ Time Frame: change from baseline to 28 days ]
    Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) Outcome Measure
  • lower extremity function [ Time Frame: change from baseline to 28 days ]
    Lower Extremity Functional Scale (LEFS)
  • patient satisfaction [ Time Frame: change from baseline to 28 days ]
    SF-12v2® Health Survey - Pain Enhanced
  • quality-adjusted life-years [ Time Frame: change from baseline to 28 days ]
    EuroQol (EQ-5D)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Botulinum Toxin Type A for Neuroma Pain
Official Title  ICMJE A Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Clinical Trial of Botulinum Toxin Type A for Neuroma Pain
Brief Summary

The purpose of this study is to determine if botulinum toxin type A (Btx-A) is an effective treatment for painful neuromas. The ideal therapy for painful neuromas would be effective, non-addictive, safe, localized, and cost-effective treatment. At the same time, the therapy would also address the complex peripheral and central mechanisms. Btx-A is a potential treatment that addresses each of these requirements while preserving the existing sensation and function.

Study Hypothesis: Btx-A injection relieves neuroma pain better than a placebo

Detailed Description

PROJECT SUMMARY OVERVIEW: The purpose of this study is to determine if botulinum toxin type A (Btx-A) is an effective treatment for painful neuromas. The ideal therapy for painful neuromas would be effective, non-addictive, safe, localized, and cost-effective, but would also address the complex peripheral and central mechanisms. Btx-A is a potential treatment that addresses each of these requirements while preserving the existing sensation and function. The investigators believe that Btx-A will be effective in eliminating both the exaggerated local pain response and centralization while maintaining an exceptional safety profile and potential for long-term effects without addictive properties.

STUDY AIMS: The aims of this proposal are to 1) examine the short-term efficacy of Btx-A injection compared to placebo in treating pain due to nerve damage, and 2) describe the long-term efficacy of Btx-A injection in treating pain due to nerve damage by measuring patient satisfaction and quality of life changes over time.

APPROACH: Forty patients will be enrolled; twenty to receive active treatment (Btx-A) and twenty to receive placebo (saline). Comparisons between treatment and placebo will occur during the first 28 days to determine Btx-A's short-term efficacy. Telephone follow-up visits will occur on Day 2 and Week 1. On Day 28, a telephone follow-up visit will occur, except in patients who are experiencing complications. Patients with complications or recurrent pain will return for a clinic visit. Post-assessment on Day 28 marks the beginning of the longitudinal observational study of patient outcomes. Placebo will no longer be used and patients still suffering from pain will be eligible for additional Btx-A injections. Patients may receive up to 4 injections of Btx-A during the 1-year study period if pain recurs. During the study period participants will be followed to collect data on pain-free intervals, subsequent treatment choices, patient satisfaction, and changes in quality of life and function. Group comparisons will be made to analyze results. Further stratifications for data analysis will be made as enrollment numbers allow to control for additional demographic and disease variables. Quality-adjusted life-years will be calculated to help determine the societal and individual cost of this treatment.

HYPOTHESIS: The investigators hypothesize that 1) Btx-A injection relieves neuroma pain better than a placebo within 28 days of injection, and 2) Btx-A injection relieves neuroma pain for longer than 28 days, improving patient quality of life. Through this study the investigators intend to further elucidate the efficacy of injected Btx-A on relieving chronic pain from nerve damage while characterizing the patients for whom this treatment is most effective.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Neuroma
Intervention  ICMJE
  • Drug: onabotulinum toxin type-A
    1 injection of Btx-A
    Other Names:
    • Botulinum Toxin Type A
    • Botox
  • Other: placebo
    1 injection of saline solution
  • Drug: 2nd phase - onabotulinum toxin type-A
    2 - 3 injections of Btx-A, specific to patient pain recurrence
    Other Names:
    • Botulinum Toxin Type A
    • Botox
Study Arms  ICMJE
  • Active Comparator: onabotulinum toxin type-A
    1 injection of Btx-A, or up to 4 injections of Btx-A during the 1-year study period if pain recurs
    Intervention: Drug: onabotulinum toxin type-A
  • Placebo Comparator: placebo
    saline
    Intervention: Other: placebo
  • Active Comparator: 2nd phase - onabotulinum toxin type-A
    2 - 3 injections of Btx-A, specific to patient pain recurrence
    Intervention: Drug: 2nd phase - onabotulinum toxin type-A
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 25, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2011)
40
Estimated Study Completion Date  ICMJE September 2017
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female
  • aged 18-75 years
  • diagnosed with neuroma pain
  • able to return/be available for follow-up evaluations
  • willingness and ability to give informed consent

Exclusion Criteria:

  • positive for HIV/AIDS or otherwise immunocompromised
  • history of neuromuscular disease
  • reported allergy to BOTOX®
  • history or symptoms of any significant medical problem in the last year (i.e., bradycardia, impaired cardiovascular function, liver disease)
  • symptoms of infection or illness with initial enrollment
  • pregnant or lactating women
  • unable or unwilling to maintain abstinence or use contraception for 28 days following all injections
  • cognitively impaired patients unable to give informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01374191
Other Study ID Numbers  ICMJE NEU-SIUSOM-11-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Southern Illinois University
Study Sponsor  ICMJE Southern Illinois University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael A. Neumeister, MD Southern Illinois University School of Medicine
PRS Account Southern Illinois University
Verification Date August 2015

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