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

Pain Clinical Trial

— MOSAIC  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02485795
• Other study ID #: PB007
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 26, 2015
• Last updated: May 31, 2017
• Start date: September 2014
• Est. completion date: August 2017

Study information

• Verified date: May 2017
• Source: Proove Bioscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50000
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Steven J. Waltrip M.D. Inc.	Beverly Hills	California
United States	Compass Pain Care	Charleston	South Carolina
United States	Palmetto Pain Management	Columbia	South Carolina
United States	Wellspring Pain Solutions	Columbus	Indiana
United States	El Paso Orthopaedic Surgery Group	El Paso	Texas
United States	Nuvo Spine	Encino	California
United States	Integrated Pain Solutions of South FL	Fort Lauderdale	Florida
United States	Medical Centre Pain Mgmt	Fort Worth	Texas
United States	Spinal Interventional Research	Gulf Breeze	Florida
United States	Spine Specialty Clinic of Arkansas	Heber Springs	Arkansas
United States	KSF Orthopaedic Center	Houston	Texas
United States	TX Spine and Joint	Houston	Texas
United States	North Hills Pain	Hurst	Texas
United States	Stuart B Krost MD	Lake Worth	Florida
United States	Memorial Orthopaedic Surgical Group	Long Beach	California
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Snibbe Orthopedics	Los Angeles	California
United States	National Spine And Pain Centers	McLean	Virginia
United States	Dr. Todd Joye	Mount Pleasant	South Carolina
United States	Coastal Interventional Pain Associates	Myrtle Beach	South Carolina
United States	Pain, Spine and Sports Medicine	Myrtle Beach	South Carolina
United States	Palmetto Spine and Pain Care Consultants	Myrtle Beach	South Carolina
United States	Panama Interventional Pain Management	Panama City Beach	Florida
United States	Interventional Pain Physicians of South Florida	Pembroke Pines	Florida
United States	Central Arizona Pain Institute	Prescott	Arizona
United States	San Diego Pain Institute	San Diego	California
United States	Neurological Spine & Pain	Savannah	Georgia
United States	The Woodlands Pain Institute	Shenandoah	Texas
United States	Northwest Spine and Pain Medicine	Spokane	Washington
United States	Victoria Pain and Rehabilitation Center	Victoria	Texas
United States	Dr. Anuj Gupta	Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Proove Bioscience, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores on the Pain Numeric Rating Scale (NRS)		60 days
Primary	Function/Disability assessment on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)		60 days
Primary	Number of Participants that Experience of Adverse Events		Up to 2 years
Primary	Type of Adverse Events Experienced by Participants		Up to 2 years
Primary	Severity of Adverse Events Experienced by Participants		Up to 2 years
Primary	Type of treatments selected for participants		60 days
Primary	Medication dosage prescribed to the participants		60 days
Primary	Frequency of participant urine drug screens		60 days
Primary	Self-rated response levels to prescribed medications		60 days
Secondary	Co-occurring disorders reported by ICD-9/10 code		60 days
Secondary	Assessment of previous treatments		60 days
Secondary	Urine drug screen results		60 days