Botulinum Toxin Type A for Neuroma Pain

August 25, 2015 updated by: Southern Illinois University

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: onabotulinum toxin type-A
1 injection of Btx-A
Other Names:
  • Botox
  • Botulinum Toxin Type A
Placebo Comparator: placebo
saline
Other: placebo
1 injection of saline solution
Active Comparator: 2nd phase - onabotulinum toxin type-A
2 - 3 injections of Btx-A, specific to patient pain recurrence
Drug: 2nd phase - onabotulinum toxin type-A
2 - 3 injections of Btx-A, specific to patient pain recurrence
Other Names:
  • Botox
  • Botulinum Toxin Type A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
change from baseline to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: change from baseline to 28 days
SF-12v2® Health Survey - Pain Enhanced
change from baseline to 28 days
upper extremity function
Time Frame: change from baseline to 28 days
Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) Outcome Measure
change from baseline to 28 days
lower extremity function
Time Frame: change from baseline to 28 days
Lower Extremity Functional Scale (LEFS)
change from baseline to 28 days
patient satisfaction
Time Frame: change from baseline to 28 days
SF-12v2® Health Survey - Pain Enhanced
change from baseline to 28 days
quality-adjusted life-years
Time Frame: change from baseline to 28 days
EuroQol (EQ-5D)
change from baseline to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern Illinois University

Investigators

  • Principal Investigator: Michael A. Neumeister, MD, Southern Illinois University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

June 13, 2011

First Submitted That Met QC Criteria

June 14, 2011

First Posted (Estimate)

June 15, 2011

Study Record Updates

Last Update Posted (Estimate)

August 26, 2015

Last Update Submitted That Met QC Criteria

August 25, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEU-SIUSOM-11-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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