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

Sponsor

Proove Bioscience, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02485795

Collaborator

(none)

50,000

Enrollment

Locations

Duration (Months)

1612.9

Patients Per Site

46.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Chronic Pain Back Pain Nociceptive Pain Neuropathic Pain Musculoskeletal Pain Neck Pain Pain, Intractable	Other: Observational

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2014

Anticipated Primary Completion Date :

Jun 1, 2017

Anticipated Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Pain patients Observational; Patients presenting to interventional pain management centers for therapy.	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.

Arm

Intervention/Treatment

Pain patients

Observational; Patients presenting to interventional pain management centers for therapy.

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.

Outcome Measures

Primary Outcome Measures

Pain Scores on the Pain Numeric Rating Scale (NRS) [60 days]
Function/Disability assessment on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [60 days]
Number of Participants that Experience of Adverse Events [Up to 2 years]
Type of Adverse Events Experienced by Participants [Up to 2 years]
Severity of Adverse Events Experienced by Participants [Up to 2 years]
Type of treatments selected for participants [60 days]
Medication dosage prescribed to the participants [60 days]
Frequency of participant urine drug screens [60 days]
Self-rated response levels to prescribed medications [60 days]

Secondary Outcome Measures

Co-occurring disorders reported by ICD-9/10 code [60 days]
Assessment of previous treatments [60 days]
Urine drug screen results [60 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Arizona Pain Institute	Prescott	Arizona	United States	86301
2	Spine Specialty Clinic of Arkansas	Heber Springs	Arkansas	United States	72543
3	Steven J. Waltrip M.D. Inc.	Beverly Hills	California	United States	90212
4	Nuvo Spine	Encino	California	United States	91316
5	Memorial Orthopaedic Surgical Group	Long Beach	California	United States	90806
6	Cedars Sinai Medical Center	Los Angeles	California	United States	90048
7	Snibbe Orthopedics	Los Angeles	California	United States	90948
8	San Diego Pain Institute	San Diego	California	United States	92111
9	Dr. Anuj Gupta	Vista	California	United States	92083
10	Integrated Pain Solutions of South FL	Fort Lauderdale	Florida	United States	33308
11	Spinal Interventional Research	Gulf Breeze	Florida	United States	32561
12	Stuart B Krost MD	Lake Worth	Florida	United States	33462
13	Panama Interventional Pain Management	Panama City Beach	Florida	United States	32407
14	Interventional Pain Physicians of South Florida	Pembroke Pines	Florida	United States	33028
15	Neurological Spine & Pain	Savannah	Georgia	United States	31405
16	Wellspring Pain Solutions	Columbus	Indiana	United States	47203
17	Compass Pain Care	Charleston	South Carolina	United States	29406
18	Palmetto Pain Management	Columbia	South Carolina	United States	29204
19	Dr. Todd Joye	Mount Pleasant	South Carolina	United States	29464
20	Coastal Interventional Pain Associates	Myrtle Beach	South Carolina	United States	29579
21	Pain, Spine and Sports Medicine	Myrtle Beach	South Carolina	United States	29588
22	Palmetto Spine and Pain Care Consultants	Myrtle Beach	South Carolina	United States	29588
23	El Paso Orthopaedic Surgery Group	El Paso	Texas	United States	79902
24	Medical Centre Pain Mgmt	Fort Worth	Texas	United States	76104
25	TX Spine and Joint	Houston	Texas	United States	77050
26	KSF Orthopaedic Center	Houston	Texas	United States	77090
27	North Hills Pain	Hurst	Texas	United States	76054
28	The Woodlands Pain Institute	Shenandoah	Texas	United States	77380
29	Victoria Pain and Rehabilitation Center	Victoria	Texas	United States	77904
30	National Spine And Pain Centers	McLean	Virginia	United States	22102
31	Northwest Spine and Pain Medicine	Spokane	Washington	United States	99204