Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management (MOSAIC)

A Multicenter Longitudinal Observational Study Evaluating Genotypic Association wIth Clinical Outcomes in Interventional Pain Management Modalities

The purpose of this study is to evaluate the impact of genetic testing on healthcare decisions and patient outcomes in interventional pain management clinical care. Results of genetic testing will also be compared with the clinical outcome measures collected to discover novel genetic factors that may influence patient care.

Study Overview

• Status: Unknown
• Conditions: Pain; Back Pain; Musculoskeletal Pain; Chronic Pain; Neck Pain; Neuropathic Pain; Pain, Intractable; Nociceptive Pain
• Intervention / Treatment: Other: Observational

Detailed Description

Specific genetic variations have been identified that result in alteration of expression or function of receptors, enzymes, and transporters that are relevant to the safety and efficacy of a medical treatment. By providing information regarding the genetic risks and the most effective therapy for an individual patient, clinicians may improve the efficacy of treatment and decrease the risk of adverse events.

The purpose of this study is to evaluate how currently available genetic tests are being implemented in various interventional pain management clinics around the United States, and whether this information results in benefits to patient care. Considering patient genotype correlates with pain sensitivity and perception, as well as autonomic nervous system dysfunction due to variations in sodium and potassium channels, genotypic associations can significantly improve outcomes in interventional pain management modalities including:

• Injections (also called nerve blocks using medications), such as steroids and opioids, including epidural steroid injections, facet joint injections, single nerve root blocks, and sacroiliac joint injections;
• Radiofrequency Rhizotomy (radiofrequency ablation and neuroablation), using x-ray guidance and a needle with an electrode at the tip that gets heated, to temporarily turn off a nerve's ability to send pain messages to the brain; and,
• Intrathecal pump implants which provide potent medications straight to the source of pain.

Patient that are receiving Proove Bioscience's genetic testing will complete validated questionnaires to measure specific outcomes related to their treatment at each clinical visit, including medication efficacy, reduction in adverse drug events, and healthcare utilization. Physicians will document any changes made to treatment regimens, including adjustments to medications or non-pharmacological treatments, and any improvements in the outcome measures. Statistical analysis will be performed to calculate relationships between genotypic and phenotypic data points collected in this study.

The results of this study will provide a measurable understanding of the medical and economic value of implementing genetic testing into interventional pain management. Furthermore, data points collected will be used to examine novel correlations and associations between single nucleotide polymorphisms and longitudinal clinical outcome measures.

• Study Type: Observational
• Enrollment (Anticipated): 50000

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Prescott, Arizona, United States, 86301
      • Central Arizona Pain Institute
  • Arkansas
    • Heber Springs, Arkansas, United States, 72543
      • Spine Specialty Clinic of Arkansas
  • California
    • Beverly Hills, California, United States, 90212
      • Steven J. Waltrip M.D. Inc.
    • Encino, California, United States, 91316
      • Nuvo Spine
    • Long Beach, California, United States, 90806
      • Memorial Orthopaedic Surgical Group
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • Los Angeles, California, United States, 90948
      • Snibbe Orthopedics
    • San Diego, California, United States, 92111
      • San Diego Pain Institute
    • Vista, California, United States, 92083
      • Dr. Anuj Gupta
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Integrated Pain Solutions of South FL
    • Gulf Breeze, Florida, United States, 32561
      • Spinal Interventional Research
    • Lake Worth, Florida, United States, 33462
      • Stuart B Krost MD
    • Panama City Beach, Florida, United States, 32407
      • Panama Interventional Pain Management
    • Pembroke Pines, Florida, United States, 33028
      • Interventional Pain Physicians of South Florida
  • Georgia
    • Savannah, Georgia, United States, 31405
      • Neurological Spine & Pain
  • Indiana
    • Columbus, Indiana, United States, 47203
      • Wellspring Pain Solutions
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Compass Pain Care
    • Columbia, South Carolina, United States, 29204
      • Palmetto Pain Management
    • Mount Pleasant, South Carolina, United States, 29464
      • Dr. Todd Joye
    • Myrtle Beach, South Carolina, United States, 29579
      • Coastal Interventional Pain Associates
    • Myrtle Beach, South Carolina, United States, 29588
      • Pain, Spine and Sports Medicine
    • Myrtle Beach, South Carolina, United States, 29588
      • Palmetto Spine and Pain Care Consultants
  • Texas
    • El Paso, Texas, United States, 79902
      • El Paso Orthopaedic Surgery Group
    • Fort Worth, Texas, United States, 76104
      • Medical Centre Pain Mgmt
    • Houston, Texas, United States, 77050
      • TX Spine and Joint
    • Houston, Texas, United States, 77090
      • KSF Orthopaedic Center
    • Hurst, Texas, United States, 76054
      • North Hills Pain
    • Shenandoah, Texas, United States, 77380
      • The Woodlands Pain Institute
    • Victoria, Texas, United States, 77904
      • Victoria Pain and Rehabilitation Center
  • Virginia
    • McLean, Virginia, United States, 22102
      • National Spine and Pain Centers
  • Washington
    • Spokane, Washington, United States, 99204
      • Northwest Spine and Pain Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be adult patients who are candidates for interventional pain management treatments, including Injections, Radio-frequency, Intrathecal pump implants, etc. All patients are receiving routine medical visits for their care and will have Proove laboratory genetic testing performed.

Description

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
• Male or Female, at least 18 years of age
• Currently taking or a candidate for opioid pain medication
• Documented or recent complaint of pain within 90 days (location to be documented in the case report form) with initial date of onset

Exclusion Criteria:

• Severe hepatic or renal disease (where current pharmaceutical dosing is affected and/or requires adjustment of standard dosing prior to PGx testing)
• 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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pain patients; Observational; Patients presenting to interventional pain management centers for therapy.	Other: Observational; This study will evaluate the impact of genetic testing information on medical regimen plans and whether this information results in benefits to patient care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain Scores on the Pain Numeric Rating Scale (NRS)	60 days
Function/Disability assessment on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	60 days
Number of Participants that Experience of Adverse Events	Up to 2 years
Type of Adverse Events Experienced by Participants	Up to 2 years
Severity of Adverse Events Experienced by Participants	Up to 2 years
Type of treatments selected for participants	60 days
Medication dosage prescribed to the participants	60 days
Frequency of participant urine drug screens	60 days
Self-rated response levels to prescribed medications	60 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Co-occurring disorders reported by ICD-9/10 code	60 days
Assessment of previous treatments	60 days
Urine drug screen results	60 days

Collaborators and Investigators

• Sponsor: Proove Bioscience, Inc.
• Investigators: Principal Investigator: Maneesh Sharma, M.D., Interventional Pain Institute

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: June 26, 2015
• First Submitted That Met QC Criteria: June 26, 2015
• First Posted (Estimate): June 30, 2015

Study Record Updates

• Last Update Posted (Actual): June 1, 2017
• Last Update Submitted That Met QC Criteria: May 31, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Genetic Polymorphism; Pain Management; Healthcare Utilization; Genetic Variation; Polymorphism, Single Nucleotide Genetic Association Studies
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Chronic Pain; Neuralgia; Neck Pain; Musculoskeletal Pain; Pain, Intractable; Nociceptive Pain
• Other Study ID Numbers: PB007