Clinical trial NCT02485795: Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management
Official title: A Multicenter Longitudinal Observational Study Evaluating Genotypic Association wIth Clinical Outcomes in Interventional Pain Management Modalities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Chronic Pain
Back Pain
Nociceptive Pain
Neuropathic Pain
Musculoskeletal Pain
Neck Pain
Pain, Intractable
Keywords: Pain Management
Genetic Variation
Genetic Polymorphism
Polymorphism, Single Nucleotide Genetic Association Studies
Healthcare Utilization
Lead sponsor: Proove Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-30
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Scores on the Pain Numeric Rating Scale (NRS)
timeFrame: 60 days
measure: Function/Disability assessment on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 60 days
measure: Number of Participants that Experience of Adverse Events
timeFrame: Up to 2 years
measure: Type of Adverse Events Experienced by Participants
timeFrame: Up to 2 years
measure: Severity of Adverse Events Experienced by Participants
timeFrame: Up to 2 years
measure: Type of treatments selected for participants
timeFrame: 60 days
measure: Medication dosage prescribed to the participants
timeFrame: 60 days
measure: Frequency of participant urine drug screens
timeFrame: 60 days
measure: Self-rated response levels to prescribed medications
timeFrame: 60 days
Secondary outcomes:
measure: Co-occurring disorders reported by ICD-9/10 code
timeFrame: 60 days
measure: Assessment of previous treatments
timeFrame: 60 days
measure: Urine drug screen results
timeFrame: 60 days
Other outcomes:
Locations:
city: Prescott
country: United States
facility: Central Arizona Pain Institute
state: Arizona
city: Heber Springs
country: United States
facility: Spine Specialty Clinic of Arkansas
state: Arkansas
city: Beverly Hills
country: United States
facility: Steven J. Waltrip M.D. Inc.
state: California
city: Encino
country: United States
facility: Nuvo Spine
state: California
city: Long Beach
country: United States
facility: Memorial Orthopaedic Surgical Group
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Snibbe Orthopedics
state: California
city: San Diego
country: United States
facility: San Diego Pain Institute
state: California
city: Vista
country: United States
facility: Dr. Anuj Gupta
state: California
city: Fort Lauderdale
country: United States
facility: Integrated Pain Solutions of South FL
state: Florida
city: Gulf Breeze
country: United States
facility: Spinal Interventional Research
state: Florida
city: Lake Worth
country: United States
facility: Stuart B Krost MD
state: Florida
city: Panama City Beach
country: United States
facility: Panama Interventional Pain Management
state: Florida
city: Pembroke Pines
country: United States
facility: Interventional Pain Physicians of South Florida
state: Florida
city: Savannah
country: United States
facility: Neurological Spine & Pain
state: Georgia
city: Columbus
country: United States
facility: Wellspring Pain Solutions
state: Indiana
city: Charleston
country: United States
facility: Compass Pain Care
state: South Carolina
city: Columbia
country: United States
facility: Palmetto Pain Management
state: South Carolina
city: Mount Pleasant
country: United States
facility: Dr. Todd Joye
state: South Carolina
city: Myrtle Beach
country: United States
facility: Coastal Interventional Pain Associates
state: South Carolina
city: Myrtle Beach
country: United States
facility: Pain, Spine and Sports Medicine
state: South Carolina
city: Myrtle Beach
country: United States
facility: Palmetto Spine and Pain Care Consultants
state: South Carolina
city: El Paso
country: United States
facility: El Paso Orthopaedic Surgery Group
state: Texas
city: Fort Worth
country: United States
facility: Medical Centre Pain Mgmt
state: Texas
city: Houston
country: United States
facility: TX Spine and Joint
state: Texas
city: Houston
country: United States
facility: KSF Orthopaedic Center
state: Texas
city: Hurst
country: United States
facility: North Hills Pain
state: Texas
city: Shenandoah
country: United States
facility: The Woodlands Pain Institute
state: Texas
city: Victoria
country: United States
facility: Victoria Pain and Rehabilitation Center
state: Texas
city: McLean
country: United States
facility: National Spine And Pain Centers
state: Virginia
city: Spokane
country: United States
facility: Northwest Spine and Pain Medicine
state: Washington
Study officials:
affiliation: Interventional Pain Institute
name: Maneesh Sharma, M.D.
role: PRINCIPAL_INVESTIGATOR
References: