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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02480075
First Posted: June 24, 2015
Last Update Posted: March 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Southern California
Information provided by (Responsible Party):
Proove Bioscience, Inc.
  Purpose
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.

Condition Intervention
Pain Chronic Pain Other: Observational

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Therapeutic Evaluation to Research Clinical Objectives Linking Genotypic and Phenotypic Associations With Pain Management Outcomes

Resource links provided by NLM:


Further study details as provided by Proove Bioscience, Inc.:

Primary Outcome Measures:
  • Pain Scores on the Pain Numeric Rating Scale (NRS) [ Time Frame: Up to 2 years ]
  • Pain Scores on the CSS-17 [ Time Frame: Up to 2 years ]
    The Chronic Regional Pain Syndrome (CRPS) Severity Score (CSS-17) is used for patients with CRPS.

  • Function/Disability assessment on the Oswestry Disability Index (ODI) [ Time Frame: Up to 2 years ]
    The ODI is used for patients with back or neck pain.

  • Function/Disability assessment on the Headache Impact Test (HIT-6) [ Time Frame: Up to 2 years ]
    The HIT-6 is used for patients with headaches or migraines.

  • Health-Related Quality of Life assessment on the SF-12v2 [ Time Frame: Up to 2 years ]
    The Short Form 12 item-version 2 (SF-12v2) is a generic assessment of health-related quality of life.

  • Presence and Severity of Generalized Anxiety Disorder on the GAD-2/GAD-7 [ Time Frame: Up to 2 years ]
    The GAD-2 short screening tool consists of the first two questions of the GAD-7 scale.

  • Presence and Severity of Depression on the PHQ-2/PHQ-9 [ Time Frame: Up to 2 years ]
    The PHQ-2 is a short screening tool for the PHQ-9.

  • Number of Participants that Experience of Adverse Events [ Time Frame: Up to 5 years ]
  • Type of Adverse Events Experienced by Participants [ Time Frame: Up to 5 years ]
  • Severity of Adverse Events Experienced by Participants [ Time Frame: Up to 5 years ]
  • Changes in type of treatments selected for participants [ Time Frame: Up to 5 years ]
  • Changes in medication dosage for the participants [ Time Frame: Up to 5 years ]
  • Changes in the frequency of urine drug screens [ Time Frame: Up to 5 years ]

Secondary Outcome Measures:
  • The Session Rating Scale as a measure of the Patient-provider alliance [ Time Frame: Up to 2 years ]

Estimated Enrollment: 2000
Study Start Date: November 2015
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chronic pain
Observational ; Adult patients seeking medical treatment that have been diagnosed with chronic pain.
Other: Observational
Observational Study only

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480075


Locations
United States, California
Pain Clinic at University of Southern California Keck Medical Center
Los Angeles, California, United States, 90089
Sponsors and Collaborators
Proove Bioscience, Inc.
University of Southern California
Investigators
Principal Investigator: Steven Richeimer, M.D. University of Southern California
  More Information

Responsible Party: Proove Bioscience, Inc.
ClinicalTrials.gov Identifier: NCT02480075     History of Changes
Other Study ID Numbers: PB010
First Submitted: June 15, 2015
First Posted: June 24, 2015
Last Update Posted: March 30, 2016
Last Verified: March 2016

Keywords provided by Proove Bioscience, Inc.:
Genetic Variation
Genetic Polymorphism
Polymorphism, Single Nucleotide
Genetic Association Studies

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms