NCT02485795

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50,000 (estimated)
• Sponsor: Proove Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Chronic Pain
• Back Pain
• Nociceptive Pain
• Neuropathic Pain
• Musculoskeletal Pain
• Neck Pain
• Pain, Intractable

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-06-01
• Completion: 2017-08-01
• First posted: 2015-06-30
• Last updated: 2017-06-01

Locations

31 sites across 1 country: United States