Observational Study Linking Genetic Variants With Clinical Outcomes in Pain Management

NCT02480075 | Unknown

• 1 other identifier: PB010
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Chronic Pain

Keywords

Genetic Variation; Genetic Polymorphism; Polymorphism, Single Nucleotide; Genetic Association Studies

Outcome Measures

Primary Outcomes (13)

• Pain Scores on the Pain Numeric Rating Scale (NRS)

  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.

  Up to 2 years

• Function/Disability assessment on the Oswestry Disability Index (ODI)

  The ODI is used for patients with back or neck pain.

  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.

  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.

  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.

  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.

  Up to 2 years

• Number of Participants that Experience of Adverse Events

  Up to 5 years

• Type of Adverse Events Experienced by Participants

  Up to 5 years

• Severity of Adverse Events Experienced by Participants

  Up to 5 years

• Changes in type of treatments selected for participants

  Up to 5 years

• Changes in medication dosage for the participants

  Up to 5 years

• Changes in the frequency of urine drug screens

  Up to 5 years

Secondary Outcomes (1)

• The Session Rating Scale as a measure of the Patient-provider alliance

  Up to 2 years

Study Arms (1)

Chronic pain

Observational ; Adult patients seeking medical treatment that have been diagnosed with chronic pain.

Other: Observational

Interventions

Observational OTHER

Observational Study only

Chronic pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Proove Bioscience, Inc.: lead
• University of Southern California: collaborator

Study Sites (1)

Pain Clinic at University of Southern California Keck Medical Center

Los Angeles, California, 90089, United States

Location

MeSH Terms

Conditions

Pain; Chronic Pain

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Steven Richeimer, M.D.

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 24, 2015
• Study Start: November 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: August 1, 2020
• Last Updated: March 30, 2016

Record last verified: 2016-03

Locations

US (1)