Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management
NCT ID: NCT02485795
Last Updated: 2017-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50000 participants
OBSERVATIONAL
2014-09-30
2017-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pain patients
Observational; Patients presenting to interventional pain management centers for therapy.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Proove Bioscience, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Maneesh Sharma, M.D.
Role: PRINCIPAL_INVESTIGATOR
Interventional Pain Institute
Locations
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Central Arizona Pain Institute
Prescott, Arizona, United States
Spine Specialty Clinic of Arkansas
Heber Springs, Arkansas, United States
Steven J. Waltrip M.D. Inc.
Beverly Hills, California, United States
Nuvo Spine
Encino, California, United States
Memorial Orthopaedic Surgical Group
Long Beach, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Snibbe Orthopedics
Los Angeles, California, United States
San Diego Pain Institute
San Diego, California, United States
Dr. Anuj Gupta
Vista, California, United States
Integrated Pain Solutions of South FL
Fort Lauderdale, Florida, United States
Spinal Interventional Research
Gulf Breeze, Florida, United States
Stuart B Krost MD
Lake Worth, Florida, United States
Panama Interventional Pain Management
Panama City Beach, Florida, United States
Interventional Pain Physicians of South Florida
Pembroke Pines, Florida, United States
Neurological Spine & Pain
Savannah, Georgia, United States
Wellspring Pain Solutions
Columbus, Indiana, United States
Compass Pain Care
Charleston, South Carolina, United States
Palmetto Pain Management
Columbia, South Carolina, United States
Dr. Todd Joye
Mt. Pleasant, South Carolina, United States
Coastal Interventional Pain Associates
Myrtle Beach, South Carolina, United States
Pain, Spine and Sports Medicine
Myrtle Beach, South Carolina, United States
Palmetto Spine and Pain Care Consultants
Myrtle Beach, South Carolina, United States
El Paso Orthopaedic Surgery Group
El Paso, Texas, United States
Medical Centre Pain Mgmt
Fort Worth, Texas, United States
TX Spine and Joint
Houston, Texas, United States
KSF Orthopaedic Center
Houston, Texas, United States
North Hills Pain
Hurst, Texas, United States
The Woodlands Pain Institute
Shenandoah, Texas, United States
Victoria Pain and Rehabilitation Center
Victoria, Texas, United States
National Spine And Pain Centers
McLean, Virginia, United States
Northwest Spine and Pain Medicine
Spokane, Washington, United States
Countries
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Other Identifiers
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PB007
Identifier Type: -
Identifier Source: org_study_id
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