Behavioral and Cognitive Predictors of Persistent Pain and Opioid Misuse in Chronic Pain

Recruiting

• Conditions: Chronic Back Pain
• Interventions: Other: No Intervention

• Registration Number: NCT06288282
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-20
• Status Verified: 2024-02
• Study First Submitted: 2024-02-23
• Study First Submitted QC: 2024-02-23
• Last Update Submitted: 2024-02-23
• Study First Posted: 2024-03-01
• Last Update Posted: 2024-03-01
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• With diagnoses related to chronic lower back pain
• Age above 18yrs
• Non pregnant

Exclusion Criteria

• Cancer pain

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with chronic back pain with lumbar, cervical or thoracic spine diagnoses.	No Intervention	-

Primary Outcome Measures

Name	Time	Method
Current Opioid misuse measure (COMM) surveys	within 12 months	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.
Screener and Opioid Assessment for patients with pain revised (SOAPPR)	within 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Pain Intensity with Brief Pain inventory (BPI)	within 12 months	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.

Trial Locations

Locations (1)

Mount Sinai Pain management centers; 🇺🇸 New York, New York, United States