Observational Study Linking Genetic Variants With Clinical Outcomes in Pain Management (TROJAN)
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|ClinicalTrials.gov Identifier: NCT02480075|
Recruitment Status : Enrolling by invitation
First Posted : June 24, 2015
Last Update Posted : March 30, 2016
|Condition or disease||Intervention/treatment|
|Pain Chronic Pain||Other: Observational|
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|
|Estimated Enrollment :||2000 participants|
|Official Title:||Therapeutic Evaluation to Research Clinical Objectives Linking Genotypic and Phenotypic Associations With Pain Management Outcomes|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||August 2020|
Observational ; Adult patients seeking medical treatment that have been diagnosed with chronic pain.
Observational Study only
- 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 ]
- The Session Rating Scale as a measure of the Patient-provider alliance [ Time Frame: Up to 2 years ]
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
|United States, California|
|Pain Clinic at University of Southern California Keck Medical Center|
|Los Angeles, California, United States, 90089|
|Principal Investigator:||Steven Richeimer, M.D.||University of Southern California|