Observational Study Linking Genetic Variants With Clinical Outcomes in Pain Management (TROJAN)

Therapeutic Evaluation to Research Clinical Objectives Linking Genotypic and Phenotypic Associations With Pain Management Outcomes

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Chronic Pain
• Intervention / Treatment: Other: Observational

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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90089
      • Pain Clinic at University of Southern California Keck Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be adult patients seeking treatment at the Pain Clinic at the University of Southern California, Keck School of Medicine, in Los Angeles. Patients will have a chronic pain diagnosis and are receiving routine medical visits for their care. Treatment includes pharmacological, non-pharmacological treatment, interventional or infusion procedures, including ketamine infusion.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic pain; Observational ; Adult patients seeking medical treatment that have been diagnosed with chronic pain.	Other: Observational; Observational Study only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores on the Pain Numeric Rating Scale (NRS)		Up to 2 years
Pain Scores on the CSS-17	The Chronic Regional Pain Syndrome (CRPS) Severity Score (CSS-17) is used for patients with CRPS.	Up to 2 years
Function/Disability assessment on the Oswestry Disability Index (ODI)	The ODI is used for patients with back or neck pain.	Up to 2 years
Function/Disability assessment on the Headache Impact Test (HIT-6)	The HIT-6 is used for patients with headaches or migraines.	Up to 2 years
Health-Related Quality of Life assessment on the SF-12v2	The Short Form 12 item-version 2 (SF-12v2) is a generic assessment of health-related quality of life.	Up to 2 years
Presence and Severity of Generalized Anxiety Disorder on the GAD-2/GAD-7	The GAD-2 short screening tool consists of the first two questions of the GAD-7 scale.	Up to 2 years
Presence and Severity of Depression on the PHQ-2/PHQ-9	The PHQ-2 is a short screening tool for the PHQ-9.	Up to 2 years
Number of Participants that Experience of Adverse Events		Up to 5 years
Type of Adverse Events Experienced by Participants		Up to 5 years
Severity of Adverse Events Experienced by Participants		Up to 5 years
Changes in type of treatments selected for participants		Up to 5 years
Changes in medication dosage for the participants		Up to 5 years
Changes in the frequency of urine drug screens		Up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
The Session Rating Scale as a measure of the Patient-provider alliance	Up to 2 years

Collaborators and Investigators

• Sponsor: Proove Bioscience, Inc.
• Collaborators: University of Southern California
• Investigators: Principal Investigator: Steven Richeimer, M.D., University of Southern California

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: June 15, 2015
• First Submitted That Met QC Criteria: June 19, 2015
• First Posted (Estimate): June 24, 2015

Study Record Updates

• Last Update Posted (Estimate): March 30, 2016
• Last Update Submitted That Met QC Criteria: March 28, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Genetic Polymorphism; Polymorphism, Single Nucleotide; Genetic Association Studies; Genetic Variation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: PB010