A Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Clinical Trial of Botulinum Toxin Type A for Neuroma Pain
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- number of pain-free days
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: onabotulinum toxin type-A (Drug)
placebo
saline
干预措施: placebo (Other)
2nd phase - onabotulinum toxin type-A
2 - 3 injections of Btx-A, specific to patient pain recurrence
干预措施: 2nd phase - onabotulinum toxin type-A (Drug)
结局指标
主要结局
number of pain-free days
时间窗: change from baseline to 28 days
subjective evaluation of pain relief, using Subjective pain scales \[visual analogue scale (VAS) and faces pain assessment\]
次要结局
- upper extremity function(change from baseline to 28 days)
- quality-adjusted life-years(change from baseline to 28 days)
- quality of life(change from baseline to 28 days)
- lower extremity function(change from baseline to 28 days)
- patient satisfaction(change from baseline to 28 days)