Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management
MOSAIC
A Multicenter Longitudinal Observational Study Evaluating Genotypic Association wIth Clinical Outcomes in Interventional Pain Management Modalities
1 other identifier
observational
50,000
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2014
Typical duration for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 26, 2015
CompletedFirst Posted
Study publicly available on registry
June 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedJune 1, 2017
May 1, 2017
2.8 years
June 26, 2015
May 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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 Outcomes (3)
Co-occurring disorders reported by ICD-9/10 code
60 days
Assessment of previous treatments
60 days
Urine drug screen results
60 days
Study Arms (1)
Pain patients
Observational; Patients presenting to interventional pain management centers for therapy.
Interventions
This study will evaluate the impact of genetic testing information on medical regimen plans and whether this information results in benefits to patient care.
Eligibility Criteria
Subjects will be adult patients who are candidates for interventional pain management treatments, including Injections, Radio-frequency, Intrathecal pump implants, etc. All patients are receiving routine medical visits for their care and will have Proove laboratory genetic testing performed.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Central Arizona Pain Institute
Prescott, Arizona, 86301, United States
Spine Specialty Clinic of Arkansas
Heber Springs, Arkansas, 72543, United States
Steven J. Waltrip M.D. Inc.
Beverly Hills, California, 90212, United States
Nuvo Spine
Encino, California, 91316, United States
Memorial Orthopaedic Surgical Group
Long Beach, California, 90806, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Snibbe Orthopedics
Los Angeles, California, 90948, United States
San Diego Pain Institute
San Diego, California, 92111, United States
Dr. Anuj Gupta
Vista, California, 92083, United States
Integrated Pain Solutions of South FL
Fort Lauderdale, Florida, 33308, United States
Spinal Interventional Research
Gulf Breeze, Florida, 32561, United States
Stuart B Krost MD
Lake Worth, Florida, 33462, United States
Panama Interventional Pain Management
Panama City Beach, Florida, 32407, United States
Interventional Pain Physicians of South Florida
Pembroke Pines, Florida, 33028, United States
Neurological Spine & Pain
Savannah, Georgia, 31405, United States
Wellspring Pain Solutions
Columbus, Indiana, 47203, United States
Compass Pain Care
Charleston, South Carolina, 29406, United States
Palmetto Pain Management
Columbia, South Carolina, 29204, United States
Dr. Todd Joye
Mt. Pleasant, South Carolina, 29464, United States
Coastal Interventional Pain Associates
Myrtle Beach, South Carolina, 29579, United States
Pain, Spine and Sports Medicine
Myrtle Beach, South Carolina, 29588, United States
Palmetto Spine and Pain Care Consultants
Myrtle Beach, South Carolina, 29588, United States
El Paso Orthopaedic Surgery Group
El Paso, Texas, 79902, United States
Medical Centre Pain Mgmt
Fort Worth, Texas, 76104, United States
TX Spine and Joint
Houston, Texas, 77050, United States
KSF Orthopaedic Center
Houston, Texas, 77090, United States
North Hills Pain
Hurst, Texas, 76054, United States
The Woodlands Pain Institute
Shenandoah, Texas, 77380, United States
Victoria Pain and Rehabilitation Center
Victoria, Texas, 77904, United States
National Spine And Pain Centers
McLean, Virginia, 22102, United States
Northwest Spine and Pain Medicine
Spokane, Washington, 99204, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maneesh Sharma, M.D.
Interventional Pain Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2015
First Posted
June 30, 2015
Study Start
September 1, 2014
Primary Completion
June 1, 2017
Study Completion
August 1, 2017
Last Updated
June 1, 2017
Record last verified: 2017-05