Clinical Trial: Transdermal Compounded Pain Creams and Patient Pain Perception
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Patient Pain Perception
研究概览
简要总结
There has been a significant increase in the number of prescriptions being filled for Custom Compounded Pain Creams. This study serves to evaluate the patient perception and satisfaction with this type of pain therapy allowing us to identify any statistically relevant relationships that may exist between this type of therapy and patient pain perception. A secondary goal would be to identify any significantly relevant relationships that may exist between this change in pain perception (if any) and the patients overall sense of well-being. The investigators' null hypothesis is that greater that 85% of people will see an significant decrease in perceived pain levels and greater than 85% increase in patient overall sense of well being.
详细描述
The purpose of this study is to evaluate the level of pain perceived by chronic neuropathic and/or inflammatory pain patients using a compounded transdermal pain cream as a pain management solution. Our goal is to identify statistically relevant relationships existing between this type of pain therapy and patients' perceived pain levels.
A secondary goal of this study is to identify any statistically relevant relationships between this change in pain perception (if any) and the patient's perception of overall well-being.
This will be an observational study with a cohort observational model study design. Patients whom have been prescribed a compounded pain cream regimen as a new pain therapy but have not yet begun the regimen will be recruited.
We will work with local prescribing neurologic, orthopedic and pain clinic physicians to identify patients who will be beginning this type of therapy in the near future. Prior to administering their first dose, the participants will need to complete the consenting process. Participants may opt to review and complete the informed consent form with their doctor or with a member of the pharmacy research team.
The custom survey entitled MLP-001-PC will be administered throughout the 12 week study at 4 week intervals (baseline, 4 weeks, 8 weeks, and 12 weeks).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be in the range of 18 to 85 years of age as confirmed by state identification or passport presented upon completion of the informed consent.
- •Participants must have a diagnosis indicative of either Neuropathic or Nociceptive Pain as confirmed with the prescribing medical provider.
- •Participants must be starting a new regimen of transdermal (topic) pain therapy with multiple compounded reagents as indicated on prescription from medical provider
- •Participants must be willing to participate in the study for a minimum of 12 weeks
- •Participants must be able to provide written informed consent.
- •Participants must be able to read and understand the english language
排除标准
- •Participants must not have prior hypersensitivity or adverse events to any components of the customized prescription as indicated by their allergy history given upon registration at the pharmacy.
- •Participants must not be pregnant or planning to become pregnant within the 12 week study period and must not be breastfeeding.
- •Participants must not have a diagnosis for cancer in the last 5 years.
- •Participants legally authorized representative (LAR) will not be a substitute for the participants' written informed consent.
结局指标
主要结局
Patient Pain Perception
时间窗: 12 weeks
Patients will complete surveys every 4 weeks throughout the 12 week evaluation to rate patient pain perception.
次要结局
- Patient overall Sense of Well-Being(12 weeks)