To evaluate the change in patient pain perception with the use of a topical compounded pain cream regimen.
- Study Type: Observational [Patient Registry]
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: June 2015
This is a prospective,observational,single center, open label study of patients that receive a combination topical compounded analgesic medication with no comparator group.
Clinical Trial Outcome Measures
- Perceived pain changes
- Time Frame: 12 Week Study [Baseline, 4,8, and 12 week evaluation]
- Minimal sample size of 60 persons(maximum n=150)with a diagnosis of chronic pain (n=30 neuropathic and n=30 nociceptive primary pain-type)to determine predictors of a 30% or greater reduction of pain scores evaluated by logistic regression analyses utilizing the Brief Pain Index scores.
- Quality of Life
- Time Frame: 12 Weeks [Baseline,4,8, and 12 week evaluation]
- To evaluate the change in quality of life using the EuroQol-5D-3L survey.
Participating in This Clinical Trial
- Participants must be diagnosed with an ICD9 code indicative of chronic pain.
- Participants must be starting a new regimen of topical therapy with multiple compounded agents.
- Participants must be expecting to receive therapy for at least 12 weeks.
- Participants must be between 18 and 65 years of age.
- Participants must be able to provide sound written and verbal informed consent.
- Participants must not have prior hypersensitivity or adverse events to any of the components in the customized prescription.
- Participants must not be pregnant or breastfeeding women.
- Participants must not have a diagnosis of cancer within the past 5 years.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Medimix Specialty Pharmacy, LLC
- Provider of Information About this Clinical Study
- Overall Official(s)
- Benjamin J Epstein, PharmD, Study Chair, Medimix Specialty Pharmacy
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National Centers for Health Statistics, Chartbook on Trends in the Health Americans 2006, Special Feature: Pain. Available at: http://www.cdc.gov/nchs/data/hus/hus06.pdf. Accessed July 17,2012.
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