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
  Purpose

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


Condition Intervention Phase
Neuroma
Drug: onabotulinum toxin type-A
Other: placebo
Drug: 2nd phase - onabotulinum toxin type-A
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Clinical Trial of Botulinum Toxin Type A for Neuroma Pain

Resource links provided by NLM:


Further study details as provided by Southern Illinois University:

Primary Outcome Measures:
  • 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]


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 40
Study Start Date: January 2015
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Botulinum Toxin Type A
  • Botox
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:
  • Botulinum Toxin Type A
  • Botox

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374191

Contacts
Contact: Jennifer L Koechle, MPH 217-545-7014 jkoechle@siumed.edu

Locations
United States, Illinois
Southern Illinois University School of Medicine Not yet recruiting
Springfield, Illinois, United States, 62702
Principal Investigator: Michael W. Neumeister, MD         
Sub-Investigator: Reuben A. Beuno, Jr., MD         
Sub-Investigator: Kelli N Webb, MD         
Sub-Investigator: Theresa A. Hegge, MD, MPH         
Sub-Investigator: Nada N. Berry, MD         
Sponsors and Collaborators
Southern Illinois University
Investigators
Principal Investigator: Michael A. Neumeister, MD Southern Illinois University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Southern Illinois University
ClinicalTrials.gov Identifier: NCT01374191     History of Changes
Other Study ID Numbers: NEU-SIUSOM-11-002
Study First Received: June 13, 2011
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Southern Illinois University:
botox
neuroma pain
pain
chronic pain
botulinum toxin
botulinum toxin A
botox and pain
botox and neuroma
botox treatment
onabotulinum
onabotulinum toxin
onabotulinum toxin type A

Additional relevant MeSH terms:
Neuroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014