Clinical Trial: Compounded Pain Creams and Patient Perception

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

Official Title: Clinical Trial: Transdermal Compounded Pain Creams and Patient Pain Perception

Brief Summary: 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.

Detailed Summary:

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).

Participants will not be required to come to the pharmacy to complete the subsequent surveys. They can be mailed or emailed at the participant's discretion. Any patient whom opts to receive their survey via mail or email will need to indicate so on their patient information form and provide a signature at that time stating that all surveys will be completed on one's own behalf (See Att
Sponsor: Marwood LowCost Pharmacy

Current Primary Outcome: Patient Pain Perception [ Time Frame: 12 weeks ]

Patients will complete surveys every 4 weeks throughout the 12 week evaluation to rate patient pain perception.


Original Primary Outcome: Same as current

Current Secondary Outcome: Patient overall Sense of Well-Being [ Time Frame: 12 weeks ]

Patients will complete a survey every 4 weeks throughout the 12 week evaluation to rate their perception of overall well-being.


Original Secondary Outcome: Same as current

Information By: Marwood LowCost Pharmacy

Dates:
Date Received: December 28, 2013
Date Started: January 2014
Date Completion: January 2015
Last Updated: July 3, 2014
Last Verified: July 2014