PainMOSAICNCT02485795
Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management
An observational study of Pain and Chronic Pain, run by Proove Bioscience, Inc. at 31 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic Pain, Back Pain
- What is being tested?
- Observational
- How many people
- 50,000 participants
- Where
- 31 sitesUnited States
- Study dates
- Sep 2014to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Steven J. Waltrip M.D. Inc.
Beverly Hills, California, 90212
Compass Pain Care
Charleston, South Carolina, 29406
Palmetto Pain Management
Columbia, South Carolina, 29204
Wellspring Pain Solutions
Columbus, Indiana, 47203
El Paso Orthopaedic Surgery Group
El Paso, Texas, 79902
Nuvo Spine
Encino, California, 91316
Integrated Pain Solutions of South FL
Fort Lauderdale, Florida, 33308
Medical Centre Pain Mgmt
Fort Worth, Texas, 76104
Spinal Interventional Research
Gulf Breeze, Florida, 32561
Spine Specialty Clinic of Arkansas
Heber Springs, Arkansas, 72543
TX Spine and Joint
Houston, Texas, 77050
KSF Orthopaedic Center
Houston, Texas, 77090
North Hills Pain
Hurst, Texas, 76054
Stuart B Krost MD
Lake Worth, Florida, 33462
Memorial Orthopaedic Surgical Group
Long Beach, California, 90806
Cedars Sinai Medical Center
Los Angeles, California, 90048
Snibbe Orthopedics
Los Angeles, California, 90948
National Spine And Pain Centers
McLean, Virginia, 22102
Dr. Todd Joye
Mt. Pleasant, South Carolina, 29464
Coastal Interventional Pain Associates
Myrtle Beach, South Carolina, 29579
Pain, Spine and Sports Medicine
Myrtle Beach, South Carolina, 29588
Palmetto Spine and Pain Care Consultants
Myrtle Beach, South Carolina, 29588
Panama Interventional Pain Management
Panama City Beach, Florida, 32407
Interventional Pain Physicians of South Florida
Pembroke Pines, Florida, 33028
Central Arizona Pain Institute
Prescott, Arizona, 86301
San Diego Pain Institute
San Diego, California, 92111
Neurological Spine & Pain
Savannah, Georgia, 31405
The Woodlands Pain Institute
Shenandoah, Texas, 77380
Northwest Spine and Pain Medicine
Spokane, Washington, 99204
Victoria Pain and Rehabilitation Center
Victoria, Texas, 77904
Dr. Anuj Gupta
Vista, California, 92083
About this study
Official title: A Multicenter Longitudinal Observational Study Evaluating Genotypic Association wIth Clinical Outcomes in Interventional Pain Management Modalities
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.
Read the 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.
- Conditions
- Pain, Chronic Pain, Back Pain, Nociceptive Pain, Neuropathic Pain, Musculoskeletal Pain
- Being tested
- Observational
- Keywords
- Pain Management, Genetic Variation, Genetic Polymorphism, Polymorphism, Single Nucleotide Genetic Association Studies, Healthcare Utilization
- Medical subject headings
- Pain, Chronic Pain, Back Pain, Nociceptive Pain, Neuralgia, Musculoskeletal Pain, Neck Pain, Pain, Intractable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
This study will evaluate the impact of genetic testing information on medical regimen plans and whether this information results in benefits to patient care.
| Study group | Role | What they receive |
|---|---|---|
| Pain patients | Observational; Patients presenting to interventional pain management centers for therapy. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores on the Pain Numeric Rating Scale (NRS)
Measured: 60 days
Function/Disability assessment on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: 60 days
Number of Participants that Experience of Adverse Events
Measured: Up to 2 years
Type of Adverse Events Experienced by Participants
Measured: Up to 2 years
Severity of Adverse Events Experienced by Participants
Measured: Up to 2 years
Type of treatments selected for participants
Measured: 60 days
Medication dosage prescribed to the participants
Measured: 60 days
Frequency of participant urine drug screens
Measured: 60 days
Self-rated response levels to prescribed medications
Measured: 60 days
Secondary outcomes (3)
Co-occurring disorders reported by ICD-9/10 code
Measured: 60 days
Assessment of previous treatments
Measured: 60 days
Urine drug screen results
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startSep 2014
- Primary completionJun 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Proove Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maneesh Sharma, M.D., Principal investigator, Interventional Pain Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485795
- Sponsor's protocol ID
- PB007
- Acronym
- MOSAIC
- Status last verified
- May 2017
- First submitted
- 26 Jun 2015
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Longitudinal Observational Study Evaluating Genotypic Association wIth Clinical Outcomes in Interventional Pain Management Modalities
- ClinicalTrials.gov ID
- NCT02485795
- Acronym / sponsor ID
- MOSAIC / PB007
- Conditions
- Pain, Chronic Pain, Back Pain, Nociceptive Pain, Neuropathic Pain, Musculoskeletal Pain
- Keywords
- Pain Management, Genetic Variation, Genetic Polymorphism, Polymorphism, Single Nucleotide Genetic Association Studies, Healthcare Utilization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Proove Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain patients | – | Other: ObservationalObservational; Patients presenting to interventional pain management centers for therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalThis study will evaluate the impact of genetic testing information on medical regimen plans and whether this information results in benefits to patient care. | Other | Pain patients |
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maneesh Sharma, M.D. principal investigator
Interventional Pain Institute
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Chronic Pain, run by Proove Bioscience, Inc. at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores on the Pain Numeric Rating Scale (NRS) (time frame: 60 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.