Topical Compounded Pain Creams And Pain Perception (TOPCAPP)
Completed
- Conditions
- Pain
- Registration Number
- NCT01862848
- Lead Sponsor
- Medimix Specialty Pharmacy, LLC
- Brief Summary
To evaluate the change in patient pain perception with the use of a topical compounded pain cream regimen.
- Detailed Description
This is a prospective,observational,single center, open label study of patients that receive a combination topical compounded analgesic medication with no comparator group.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 285
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Perceived pain changes 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.
- Secondary Outcome Measures
Name Time Method Quality of Life 12 Weeks [Baseline,4,8, and 12 week evaluation] To evaluate the change in quality of life using the EuroQol-5D-3L survey.
Trial Locations
- Locations (1)
The Medimix Specialty Pharmacy, LLC
🇺🇸Jacksonville, Florida, United States