Botulinum Toxin Type A for Cold Intolerance Secondary to Digital Amputations and Replantations: A Pilot Study
试验速览
- 阶段
- 1 期
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Cold Intolerance Severity Score
研究概览
简要总结
Patients will be selected for cold intolerance after finger amputation or replantation. They will be given Botox or placebo dose as treatment and assessed over 3 months.
详细描述
Aim 1: To assess the efficacy of botulinum toxin type A on treating cold intolerance secondary to digital amputations, revascularizations, or replantations
Primary null hypothesis: Randomized subjects who receive botulinum toxin type A injections for pain associated with cold intolerance will experience similar changes in pain as compared to patients randomized to receive saline injections (control)
• As measured by the Cold Insensitivity and Severity Score (CISS) at one week, four weeks, and twelve weeks
Aim 2: To assess the safety of botulinum toxin type A on treating cold intolerance secondary to digital amputations and replantations
Hypothesis: Injection of botulinum toxin for cold intolerance secondary to digital amputations and replantations is not associated with any adverse reactions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Adults (≥18 years) diagnosed with cold intolerance secondary to digital amputations, revascularizations, or replantations and a CISS score of 30 or higher (the threshold for pathological cold intolerance)11 Ability to give informed consent
排除标准
- •Adults ≥ 75 years old Inability or unwillingness to participate in CISS or DASH survey Major medical comorbidity expected to worsen in the next 6 months Comorbid chronic pain condition Severe and untreated mental health conditions or active substance dependence Pregnant or breastfeeding Known hypersensitivity to botulinum toxin Patients with a compromised respiratory function Pre-existing neuromuscular disorders Receiving therapy with aminoglycosides, anticholinergic agents, and muscle relaxants Infection in the proposed injection site
研究组 & 干预措施
Botox
The patients in this arm will receive Botox injection to the digital arteries of all affected digits.
干预措施: Botulinum toxin type A (Drug)
Placebo
The patients in this arm will receive placebo injection of saline to the digital arteries of all affected digits.
干预措施: Botulinum toxin type A (Drug)
结局指标
主要结局
Cold Intolerance Severity Score
时间窗: 3 months
index of cold intolerance, validated
quick dash
时间窗: three months.
a validated measure of hand function
次要结局
- PHQ 9(3 months)
研究者
Jonathan M. Winograd, M.D.
Visiting Surgeon, Associate Professor Harvard Medical School
Massachusetts General Hospital