Observational Study Linking Genetic Variants With Clinical Outcomes in Pain Management

Pain Clinical Trial

— TROJAN  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02480075
• Other study ID #: PB010
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 15, 2015
• Last updated: March 28, 2016
• Start date: November 2015
• Est. completion date: August 2020

Study information

• Verified date: March 2016
• Source: Proove Bioscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: August 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pain
• Pain

Intervention

Other:
• Observational
Observational Study only

Locations

Country	Name	City	State
United States	Pain Clinic at University of Southern California Keck Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Proove Bioscience, Inc.	University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores on the Pain Numeric Rating Scale (NRS)		Up to 2 years	No
Primary	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	No
Primary	Function/Disability assessment on the Oswestry Disability Index (ODI)	The ODI is used for patients with back or neck pain.	Up to 2 years	No
Primary	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	No
Primary	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	Yes
Primary	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	No
Primary	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	No
Primary	Number of Participants that Experience of Adverse Events		Up to 5 years	No
Primary	Type of Adverse Events Experienced by Participants		Up to 5 years	Yes
Primary	Severity of Adverse Events Experienced by Participants		Up to 5 years	Yes
Primary	Changes in type of treatments selected for participants		Up to 5 years	Yes
Primary	Changes in medication dosage for the participants		Up to 5 years	No
Primary	Changes in the frequency of urine drug screens		Up to 5 years	No
Secondary	The Session Rating Scale as a measure of the Patient-provider alliance		Up to 2 years	No