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.
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
2,000
Observational Study only
Pain Clinic at University of Southern California Keck Medical Center
Los Angeles, California, United States
Pain Scores on the Pain Numeric Rating Scale (NRS)
Time frame: 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.
Time frame: Up to 2 years
Function/Disability assessment on the Oswestry Disability Index (ODI)
The ODI is used for patients with back or neck pain.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 2 years
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
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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