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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

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

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 Summary:

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, re
Sponsor: Proove Bioscience, Inc.

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Presence of co-occurring disorders [ Time Frame: 60 days ]
  • Assessment of previous treatments [ Time Frame: 60 days ]
  • Urine drug screen results [ Time Frame: 60 days ]


Information By: Proove Bioscience, Inc.

Dates:
Date Received: June 26, 2015
Date Started: September 2014
Date Completion: December 2016
Last Updated: March 28, 2016
Last Verified: March 2016