Clinical trial NCT02480075: Observational Study Linking Genetic Variants With Clinical Outcomes in Pain Management
Official title: Therapeutic Evaluation to Research Clinical Objectives Linking Genotypic and Phenotypic Associations With Pain Management Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Chronic Pain
Keywords: Genetic Variation
Genetic Polymorphism
Polymorphism, Single Nucleotide
Genetic Association Studies
Lead sponsor: Proove Bioscience, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Southern California
First posted: 2015-06-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Pain Scores on the Pain Numeric Rating Scale (NRS)
timeFrame: Up to 2 years
measure: Pain Scores on the CSS-17
timeFrame: Up to 2 years
measure: Function/Disability assessment on the Oswestry Disability Index (ODI)
timeFrame: Up to 2 years
measure: Function/Disability assessment on the Headache Impact Test (HIT-6)
timeFrame: Up to 2 years
measure: Health-Related Quality of Life assessment on the SF-12v2
timeFrame: Up to 2 years
measure: Presence and Severity of Generalized Anxiety Disorder on the GAD-2/GAD-7
timeFrame: Up to 2 years
measure: Presence and Severity of Depression on the PHQ-2/PHQ-9
timeFrame: Up to 2 years
measure: Number of Participants that Experience of Adverse Events
timeFrame: Up to 5 years
measure: Type of Adverse Events Experienced by Participants
timeFrame: Up to 5 years
measure: Severity of Adverse Events Experienced by Participants
timeFrame: Up to 5 years
measure: Changes in type of treatments selected for participants
timeFrame: Up to 5 years
measure: Changes in medication dosage for the participants
timeFrame: Up to 5 years
measure: Changes in the frequency of urine drug screens
timeFrame: Up to 5 years
Secondary outcomes:
measure: The Session Rating Scale as a measure of the Patient-provider alliance
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pain Clinic at University of Southern California Keck Medical Center
state: California
Study officials:
affiliation: University of Southern California
name: Steven Richeimer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: