Subjective Observational Study of Patients Using Transdermal Cream Medication And/Or Transdermal Patches With Or Without Oral Non-Narcotic Medications

• Conditions: Pain, Joint; Pain, Chronic; Pain Syndrome

• Registration Number: NCT03768011
• Lead Sponsor: Data Collection Analysis Business Management

Brief Summary

purpose of this study is to evaluate the level of pain perceived by patients using a transdermal cream and/or transdermal patch with or without an oral medication as a pain management solution.

Detailed Description

The purpose of this minimal risk, observational study is to observe and document patients' perspective on how the combination of transdermal cream and/or transdermal patch(s) with or without oral medication can help reduce or eliminate the use of opiate(s).

Study Timeline

• Status Verified: 2018-12
• Study Start: 2018-12-01
• Study First Submitted: 2018-12-01
• Study First Submitted QC: 2018-12-05
• Last Update Submitted: 2018-12-05
• Study First Posted: 2018-12-07
• Last Update Posted: 2018-12-07
• Primary Completion: 2021-12-01
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Participants must be diagnosed with an ICD10 code indicative of chronic pain
• Participants must be starting a new regimen of topical therapy with or without non-narcotic oral medication that has been deemed medically necessary and is independent of the study
• Participants must be expecting to receive therapy for at least 12 weeks
• Participants must be between 18 and 64 years of age
• Participants must be able to provide sound verbal informed consent

Exclusion Criteria

• Participants must not be a beneficiary of government funded healthcare program (i.e. Medicare, Medicaid, etc.)
• Participants must not have a diagnosis of cancer within the past 5 years
• Participants who have chronic pain conditions not expected to respond to topical pain medication such as deep abdominal pain, or from conditions such as cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients' perspective through a patient led Survey of Health and quality of life via patient reported outcome measures using Visual analogue scale given at Baseline and follow up. Measuring pain from 0 no pain to 10 highest pain level.	36 months	Collecting and analyzing quantitative and qualitative data to draw generalized outcome measures, on real world data.Data from the subject surveys will analyze and measure the effectiveness through a subjective observation via patients' perspective survey on transdermal cream and/or transdermal patches with or without oral non-narcotic medication and if it helped with the reduction or elimination of opiate(s).

Secondary Outcome Measures

Name	Time	Method
Visual Analogue scales	36 months	By utilizing the Visual analogue scale from the patients' perspective will generate real world data

Trial Locations

Locations (1)

DCABM; 🇺🇸 Land O' Lakes, Florida, United States