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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02485795
First Posted: June 30, 2015
Last Update Posted: June 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Proove Bioscience, Inc.
  Purpose
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.

Condition Intervention
Pain Chronic Pain Back Pain Nociceptive Pain Neuropathic Pain Musculoskeletal Pain Neck Pain Pain, Intractable Other: Observational

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter Longitudinal Observational Study Evaluating Genotypic Association wIth Clinical Outcomes in Interventional Pain Management Modalities

Resource links provided by NLM:


Further study details as provided by Proove Bioscience, Inc.:

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

Secondary Outcome Measures:
  • Co-occurring disorders reported by ICD-9/10 code [ Time Frame: 60 days ]
  • Assessment of previous treatments [ Time Frame: 60 days ]
  • Urine drug screen results [ Time Frame: 60 days ]

Estimated Enrollment: 50000
Study Start Date: September 2014
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485795


  Show 31 Study Locations
Sponsors and Collaborators
Proove Bioscience, Inc.
Investigators
Principal Investigator: Maneesh Sharma, M.D. Interventional Pain Institute
  More Information

Responsible Party: Proove Bioscience, Inc.
ClinicalTrials.gov Identifier: NCT02485795     History of Changes
Other Study ID Numbers: PB007
First Submitted: June 26, 2015
First Posted: June 30, 2015
Last Update Posted: June 1, 2017
Last Verified: May 2017

Keywords provided by Proove Bioscience, Inc.:
Pain Management
Genetic Variation
Genetic Polymorphism
Polymorphism, Single Nucleotide Genetic Association Studies
Healthcare Utilization

Additional relevant MeSH terms:
Back Pain
Chronic Pain
Neuralgia
Neck Pain
Musculoskeletal Pain
Pain, Intractable
Nociceptive Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Muscular Diseases
Musculoskeletal Diseases