Observational Study Linking Genetic Variants With Clinical Outcomes in Pain Management

NCT ID: NCT02480075

Last Updated: 2016-03-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2020-08-31

Brief Summary

The purpose of this study is to (a) evaluate the treatment approaches and changes in treatment regimens utilized by clinicians when genetic testing is performed in the clinic; and (b) create a patient data registry to identify genetic factors that influence treatment outcomes in pain management.

Detailed Description

Clinicians who treat pain have noted that the response to opioids and other pain medications varies widely among patients. Differences in the degree of pain stimulation and pain sensitivity, weight and age differences, prior opioid use and tolerance, as well as the differences in bioavailability of various opioid formulations have been cited as causes for the wide variability in analgesia seen with opioids. However, a significant component of chronic pain may also be explained by genetic polymorphisms. Genetic information may explain the variability of responses and help predict more effective (or less dangerous) treatments and medication choices and doses. By identifying the genetic risks and the most effective analgesic for an individual patient, clinicians may be able to improve the efficacy of the pain treatments and medications and decrease the risk of iatrogenically-induced overdose, addiction, and death.

The purpose of this study is to evaluate how currently available genetic tests are being implemented in a pain management setting and whether this information results in benefits to patient care. Chronic pain patients receiving routine medical visits for their care will complete validated questionnaires to measure pain levels, disability indices, mental health, and quality of life measurements at each clinical visit. Physicians will document any changes made to treatment regimens, including adjustments to medications or non-pharmacological treatments and improvements in pain, functional ratings, or patient satisfaction. Concomitantly, this study will use the collected genetic and clinical data to create a data registry in order to examine novel correlations and associations between single nucleotide polymorphisms and longitudinal datasets.

The results of this study will elucidate potential predictive variables of chronic pain development and/or treatment that will assist in making better healthcare decisions in the selection of treatment modalities and dosing of medications for chronic pain.

Conditions

Pain; Chronic Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Chronic pain

Observational ; Adult patients seeking medical treatment that have been diagnosed with chronic pain.

Observational

Intervention Type: OTHER

Observational Study only

Interventions

Observational

Observational Study only

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Provide signed and dated informed consent form.
• Willing to comply with all study procedures and be available for the duration of the study.
• Currently experiencing a chronic pain problem, with symptoms that have occurred within the last 30 days.

Exclusion Criteria

• Severe hepatic or renal disease
• Significant diminished mental capacity that is unable to understand the protocol, surveys and questionnaires; unable to read/write English or Spanish
• Recent febrile illness that precludes or delays participation by more than 1 month
• Pregnancy or lactation
• Participation in a clinical study that may interfere with participation in this study
• Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: collaborator

Proove Bioscience, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Richeimer, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Pain Clinic at University of Southern California Keck Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

PB010

Identifier Type: -

Identifier Source: org_study_id