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Chronic lower back pain (CLBP) affects approximately 20% of the global population. The study objective is to determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in patients with chronic pain. This is a prospective consented cross-sectional study characterizing behavioral and cognitive phenotypes using both patient-reported survey measures and cognitive testing. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and risk for opioid misuse (Primary outcomes: COMM scores, SOAPPR scores). Secondary outcomes is BPI measurement. A Certificate of Confidentiality will provide additional protections for participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with chronic back pain with lumbar, cervical or thoracic spine diagnoses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | No intervention will be used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Screener and Opioid Assessment for patients with pain revised (SOAPPR) | Risk of opioid misuse with the Screener and Opioid Assessment for Patients with Pain Revised (SOAPPR). The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a 24-item self-report questionnaire with total scores ranging from 0 to 24 that is used to predict risk of aberrant medication-related behaviors among chronic pain patients, with higher scores indicating higher risk of aberrant behaviors. | within 12 months |
| Current Opioid misuse measure (COMM) surveys | Current opioid misuse measures with the Current Opioid misuse measure (COMM) surveys. The COMM is a 17-item self-report measure with total scores ranging from 0 to 68 that is used to identify risk of opioid misuse among chronic pain patients, with higher scores indicating higher risk of opioid misuse. | within 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity with Brief Pain inventory (BPI) | The Brief Pain Inventory (BPI) pain intensity scale is a 0 to 10 numeric rating scale used to assess a patient's pain intensity, with 0 being no pain and 10 being pain as bad as you can imagine. Higher scores indicate higher pain intensity. | within 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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chronic back pain
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chinwe Nwaneshiudu, MD PhD | Contact | 212 241 4203 | chinwe.nwaneshiudu@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Chinwe Nwaneshiudu | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Pain management centers | Recruiting | New York | New York | 10029 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Immediately following publication. No end date.
Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.
For individual participant data meta-analysis.
Proposals should be directed to chinwe.nwaneshiudu@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third-party website (TBD)
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whole blood