Pain Clinical Trial
Official title:
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.
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