Topical Compounded Pain Creams And Pain Perception (TOPCAPP)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01862848

Acronym

TOPCAPP

Enrollment

285

Registered

2013-05-27

Start date

2012-11-30

Completion date

2015-06-30

Last updated

2015-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Topical Compounded Pain Creams and Pain Perception

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results