Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management (MOSAIC)
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|ClinicalTrials.gov Identifier: NCT02485795|
Recruitment Status : Unknown
Verified May 2017 by Proove Bioscience, Inc..
Recruitment status was: Enrolling by invitation
First Posted : June 30, 2015
Last Update Posted : June 1, 2017
|Condition or disease||Intervention/treatment|
|Pain Chronic Pain Back Pain Nociceptive Pain Neuropathic Pain Musculoskeletal Pain Neck Pain Pain, Intractable||Other: Observational|
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.
|Study Type :||Observational|
|Estimated Enrollment :||50000 participants|
|Official Title:||A Multicenter Longitudinal Observational Study Evaluating Genotypic Association wIth Clinical Outcomes in Interventional Pain Management Modalities|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||August 2017|
Observational; Patients presenting to interventional pain management centers for therapy.
This study will evaluate the impact of genetic testing information on medical regimen plans and whether this information results in benefits to patient care.
- 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 ]
- 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 ]
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
|Principal Investigator:||Maneesh Sharma, M.D.||Interventional Pain Institute|