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



Status:Enrolling by invitation
Conditions:Back Pain, Back Pain, Chronic Pain, Chronic Pain, Chronic Pain, Neurology, Orthopedic, Pain
Therapuetic Areas:Musculoskeletal, Neurology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:6/2/2017
Start Date:September 2014
End Date:August 2017

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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.

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.

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
We found this trial at
31
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Fort Worth, Texas 76104
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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120 South Spalding Drive
Beverly Hills, California 90212
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2270 Ashley Crossing Drive
Charleston, South Carolina 29406
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Charleston, SC
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1655 Bernardin Avenue
Columbia, South Carolina 29204
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2400 Northpark
Columbus, Indiana 47203
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Columbus, IN
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1720 El Paso
El Paso, Texas 79902
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El Paso, TX
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16633 Ventura Boulevard
Encino, California 91316
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Encino, CA
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5353 North Federal Highway
Fort Lauderdale, Florida 33308
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1040 Gulf Breeze Parkway
Gulf Breeze, Florida 32561
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746 Wilburn Road
Heber Springs, Arkansas 72543
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8830 Long Point Road
Houston, Texas 77050
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Houston, TX
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17270 Red Oak Drive
Houston, Texas 77090
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Houston, TX
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809 West Harwood Road
Hurst, Texas 76054
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3618 Lantana Road
Lake Worth, Florida 33462
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Long Beach, California 90806
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120 South Spalding Drive
Los Angeles, California 90948
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Mclean, Virginia 22102
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Mclean, VA
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1341 Old Georgetown Road
Mount Pleasant, South Carolina 29464
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Mount Pleasant, SC
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210 Village Center Boulevard
Myrtle Beach, South Carolina 29579
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3029 Newcastle Loop
Myrtle Beach, South Carolina 29588
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4736 Northgate Boulevard
Myrtle Beach, South Carolina 29588
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Panama City Beach, Florida 32407
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601 North Flamingo Road
Pembroke Pines, Florida 33028
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2100 Centerpointe West Drive
Prescott, Arizona 86301
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7625 Mesa College Drive
San Diego, California 92111
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4 East Jackson Boulevard
Savannah, Georgia 31405
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9200 Pinecroft Drive
Shenandoah, Texas 77380
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Spokane, Washington 99204
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115 Medical Drive
Victoria, Texas 77904
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2023 West Vista Way
Vista, California 92083
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