Observational Study Linking Genetic Variants With Clinical Outcomes in Pain Management
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Chronic Pain, Chronic Pain, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2015 |
| End Date: | August 2020 |
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.
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.
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.
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.
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.
- Currently experiencing a chronic pain problem, with symptoms that have occurred
within the last 30 days.
Exclusion Criteria:
- 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
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