PainTROJANNCT02480075
Observational Study Linking Genetic Variants With Clinical Outcomes in Pain Management
An observational study of Pain and Chronic Pain, run by Proove Bioscience, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to (a) evaluate the treatment approaches and changes in treatment regimens utilized by clinicians when genetic testing is performed in the clinic; and (b) create a patient data registry to identify genetic factors that influence treatment outcomes in pain management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic Pain
- What is being tested?
- Observational
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Aug 2020
- 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 seeking treatment at the Pain Clinic at the University of Southern California, Keck School of Medicine, in Los Angeles. Patients will have a chronic pain diagnosis and are receiving routine medical visits for their care. Treatment includes pharmacological, non-pharmacological treatment, interventional or infusion procedures, including ketamine infusion.
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.
- Currently experiencing a chronic pain problem, with symptoms that have occurred within the last 30 days.
Who cannot join
- Severe hepatic or renal disease
- 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
1 site in 1 country.
United States1 site
Pain Clinic at University of Southern California Keck Medical Center
Los Angeles, California, 90089
About this study
Official title: Therapeutic Evaluation to Research Clinical Objectives Linking Genotypic and Phenotypic Associations With Pain Management Outcomes
The purpose of this study is to (a) evaluate the treatment approaches and changes in treatment regimens utilized by clinicians when genetic testing is performed in the clinic; and (b) create a patient data registry to identify genetic factors that influence treatment outcomes in pain management.
Read the detailed description
Clinicians who treat pain have noted that the response to opioids and other pain medications varies widely among patients. Differences in the degree of pain stimulation and pain sensitivity, weight and age differences, prior opioid use and tolerance, as well as the differences in bioavailability of various opioid formulations have been cited as causes for the wide variability in analgesia seen with opioids. However, a significant component of chronic pain may also be explained by genetic polymorphisms. Genetic information may explain the variability of responses and help predict more effective (or less dangerous) treatments and medication choices and doses. By identifying the genetic risks and the most effective analgesic for an individual patient, clinicians may be able to improve the efficacy of the pain treatments and medications and decrease the risk of iatrogenically-induced overdose, addiction, and death.
The purpose of this study is to evaluate how currently available genetic tests are being implemented in a pain management setting and whether this information results in benefits to patient care. Chronic pain patients receiving routine medical visits for their care will complete validated questionnaires to measure pain levels, disability indices, mental health, and quality of life measurements at each clinical visit. Physicians will document any changes made to treatment regimens, including adjustments to medications or non-pharmacological treatments and improvements in pain, functional ratings, or patient satisfaction. Concomitantly, this study will use the collected genetic and clinical data to create a data registry in order to examine novel correlations and associations between single nucleotide polymorphisms and longitudinal datasets.
The results of this study will elucidate potential predictive variables of chronic pain development and/or treatment that will assist in making better healthcare decisions in the selection of treatment modalities and dosing of medications for chronic pain.
- Conditions
- Pain, Chronic Pain
- Being tested
- Observational
- Keywords
- Genetic Variation, Genetic Polymorphism, Polymorphism, Single Nucleotide, Genetic Association Studies
- Medical subject headings
- Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational Study only
| Study group | Role | What they receive |
|---|---|---|
| Chronic pain | Observational ; Adult patients seeking medical treatment that have been diagnosed with chronic pain. 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: Up to 2 years
Pain Scores on the CSS-17
The Chronic Regional Pain Syndrome (CRPS) Severity Score (CSS-17) is used for patients with CRPS.
Measured: Up to 2 years
Function/Disability assessment on the Oswestry Disability Index (ODI)
The ODI is used for patients with back or neck pain.
Measured: Up to 2 years
Function/Disability assessment on the Headache Impact Test (HIT-6)
The HIT-6 is used for patients with headaches or migraines.
Measured: Up to 2 years
Health-Related Quality of Life assessment on the SF-12v2
The Short Form 12 item-version 2 (SF-12v2) is a generic assessment of health-related quality of life.
Measured: Up to 2 years
Presence and Severity of Generalized Anxiety Disorder on the GAD-2/GAD-7
The GAD-2 short screening tool consists of the first two questions of the GAD-7 scale.
Measured: Up to 2 years
Presence and Severity of Depression on the PHQ-2/PHQ-9
The PHQ-2 is a short screening tool for the PHQ-9.
Measured: Up to 2 years
Number of Participants that Experience of Adverse Events
Measured: Up to 5 years
Type of Adverse Events Experienced by Participants
Measured: Up to 5 years
Severity of Adverse Events Experienced by Participants
Measured: Up to 5 years
Changes in type of treatments selected for participants
Measured: Up to 5 years
Changes in medication dosage for the participants
Measured: Up to 5 years
Changes in the frequency of urine drug screens
Measured: Up to 5 years
Secondary outcomes (1)
The Session Rating Scale as a measure of the Patient-provider alliance
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2020 (estimated)
- Study completionAug 2020 (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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Proove Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Southern California
- Responsible party
- Sponsor
- Investigators
- Steven Richeimer, M.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480075
- Sponsor's protocol ID
- PB010
- Acronym
- TROJAN
- Status last verified
- Mar 2016
- First submitted
- 15 Jun 2015
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Evaluation to Research Clinical Objectives Linking Genotypic and Phenotypic Associations With Pain Management Outcomes
- ClinicalTrials.gov ID
- NCT02480075
- Acronym / sponsor ID
- TROJAN / PB010
- Conditions
- Pain, Chronic Pain
- Keywords
- Genetic Variation, Genetic Polymorphism, Polymorphism, Single Nucleotide, Genetic Association Studies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Proove Bioscience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Southern California
- Study start
- Nov 2015
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 24 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 (a) evaluate the treatment approaches and changes in treatment regimens utilized by clinicians when genetic testing is performed in the clinic; and (b) create a patient data registry to identify genetic factors that influence treatment outcomes in pain management.
Detailed description
Clinicians who treat pain have noted that the response to opioids and other pain medications varies widely among patients. Differences in the degree of pain stimulation and pain sensitivity, weight and age differences, prior opioid use and tolerance, as well as the differences in bioavailability of various opioid formulations have been cited as causes for the wide variability in analgesia seen with opioids. However, a significant component of chronic pain may also be explained by genetic polymorphisms. Genetic information may explain the variability of responses and help predict more effective (or less dangerous) treatments and medication choices and doses. By identifying the genetic risks and the most effective analgesic for an individual patient, clinicians may be able to improve the efficacy of the pain treatments and medications and decrease the risk of iatrogenically-induced overdose, addiction, and death.
The purpose of this study is to evaluate how currently available genetic tests are being implemented in a pain management setting and whether this information results in benefits to patient care. Chronic pain patients receiving routine medical visits for their care will complete validated questionnaires to measure pain levels, disability indices, mental health, and quality of life measurements at each clinical visit. Physicians will document any changes made to treatment regimens, including adjustments to medications or non-pharmacological treatments and improvements in pain, functional ratings, or patient satisfaction. Concomitantly, this study will use the collected genetic and clinical data to create a data registry in order to examine novel correlations and associations between single nucleotide polymorphisms and longitudinal datasets.
The results of this study will elucidate potential predictive variables of chronic pain development and/or treatment that will assist in making better healthcare decisions in the selection of treatment modalities and dosing of medications for chronic pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic pain | – | Other: ObservationalObservational ; Adult patients seeking medical treatment that have been diagnosed with chronic pain. |
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 seeking treatment at the Pain Clinic at the University of Southern California, Keck School of Medicine, in Los Angeles. Patients will have a chronic pain diagnosis and are receiving routine medical visits for their care. Treatment includes pharmacological, non-pharmacological treatment, interventional or infusion procedures, including ketamine infusion.
Key inclusion criteria (3 listed)
- Provide signed and dated informed consent form.
- Willing to comply with all study procedures and be available for the duration of the study.
- Currently experiencing a chronic pain problem, with symptoms that have occurred within the last 30 days.
Key exclusion criteria (6 listed)
- Severe hepatic or renal disease
- 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 |
|---|---|---|
| ObservationalObservational Study only | Other | Chronic pain |
Primary outcome
Pain Scores on the Pain Numeric Rating Scale (NRS)
Time frame: Up to 2 years
Pain Scores on the CSS-17
Time frame: Up to 2 years
The Chronic Regional Pain Syndrome (CRPS) Severity Score (CSS-17) is used for patients with CRPS.
Function/Disability assessment on the Oswestry Disability Index (ODI)
Time frame: Up to 2 years
The ODI is used for patients with back or neck pain.
Function/Disability assessment on the Headache Impact Test (HIT-6)
Time frame: Up to 2 years
The HIT-6 is used for patients with headaches or migraines.
Health-Related Quality of Life assessment on the SF-12v2
Time frame: Up to 2 years
The Short Form 12 item-version 2 (SF-12v2) is a generic assessment of health-related quality of life.
Presence and Severity of Generalized Anxiety Disorder on the GAD-2/GAD-7
Time frame: Up to 2 years
The GAD-2 short screening tool consists of the first two questions of the GAD-7 scale.
Presence and Severity of Depression on the PHQ-2/PHQ-9
Time frame: Up to 2 years
The PHQ-2 is a short screening tool for the PHQ-9.
Number of Participants that Experience of Adverse Events
Time frame: Up to 5 years
Type of Adverse Events Experienced by Participants
Time frame: Up to 5 years
Severity of Adverse Events Experienced by Participants
Time frame: Up to 5 years
Changes in type of treatments selected for participants
Time frame: Up to 5 years
Changes in medication dosage for the participants
Time frame: Up to 5 years
Changes in the frequency of urine drug screens
Time frame: Up to 5 years
1 secondary outcome
The Session Rating Scale as a measure of the Patient-provider alliance
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
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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.
Steven Richeimer, M.D. principal investigator
University of Southern California
1 site 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 1 site 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 3 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 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: Up to 2 years). The study lists 13 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 30 Mar 2016.