Botulinum Toxin Type A for Neuroma Pain

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Southern Illinois University
Sponsor:
Information provided by (Responsible Party):
Southern Illinois University
ClinicalTrials.gov Identifier:
NCT01374191
First received: June 13, 2011
Last updated: June 12, 2014
Last verified: June 2014

June 13, 2011
June 12, 2014
January 2015
May 2017   (final data collection date for primary outcome measure)
number of pain-free days [ Time Frame: change from baseline to 28 days ] [ Designated as safety issue: No ]
subjective evaluation of pain relief, using Subjective pain scales [visual analogue scale (VAS) and faces pain assessment]
Same as current
Complete list of historical versions of study NCT01374191 on ClinicalTrials.gov Archive Site
  • quality of life [ Time Frame: change from baseline to 28 days ] [ Designated as safety issue: No ]
    SF-12v2® Health Survey - Pain Enhanced
  • upper extremity function [ Time Frame: change from baseline to 28 days ] [ Designated as safety issue: No ]
    Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) Outcome Measure
  • lower extremity function [ Time Frame: change from baseline to 28 days ] [ Designated as safety issue: No ]
    Lower Extremity Functional Scale (LEFS)
  • patient satisfaction [ Time Frame: change from baseline to 28 days ] [ Designated as safety issue: No ]
    SF-12v2® Health Survey - Pain Enhanced
  • quality-adjusted life-years [ Time Frame: change from baseline to 28 days ] [ Designated as safety issue: No ]
    EuroQol (EQ-5D)
Same as current
Not Provided
Not Provided
 
Botulinum Toxin Type A for Neuroma Pain
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Clinical Trial of Botulinum Toxin Type A for Neuroma Pain

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Neuroma
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
September 2017
May 2017   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Jennifer L Koechle, MPH 217-545-7014 jkoechle@siumed.edu
United States
 
NCT01374191
NEU-SIUSOM-11-002
Yes
Southern Illinois University
Southern Illinois University
Not Provided
Principal Investigator: Michael A. Neumeister, MD Southern Illinois University School of Medicine
Southern Illinois University
June 2014

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