Neurocognitive and Genomic Predictors of Persistent Pain and Opioid Misuse After Spine Surgery

Recruiting

• Conditions: Lumbar Spine Pathology; Elective Spine Surgery
• Interventions: Other: No Intervention

• Registration Number: NCT06288256
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

Having spine surgery and recovery is a vulnerable period when opioid naive patients may transition into long-term use of opioids, and when previously opioid tolerant patients may be at risk to continue towards long-term opioid use and dependence. However, little is known about risk for developing opioid misuse, taking opioids differently than indicated or prescribed, and later OUD. This study addresses the question of whether behavior, cognitive features, and genomic markers can predict misuse of opioids, persistent pain and disability in individuals after spine surgery.

To determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in spine surgery patients with differential gene expression.

This is a prospective observational longitudinal study characterizing behavioral phenotypes in adults undergoing spine surgery using both patient-reported survey measures, cognitive testing and blood sampling. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and opioid misuse with spine related disability, and gene expression counts.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-27
• Study First Submitted: 2024-02-23
• Study First Submitted QC: 2024-02-23
• Study First Posted: 2024-03-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age over 18
• With diagnoses of lumbar, cervical or thoracic spine pathology, scheduled to undergo elective spine surgery with or without instrumentation

Exclusion Criteria

• Severe psychiatric condition interfering with study participation Any major cardiac, pulmonary, renal, infectious, hepatic condition that interferes with study participation
• Polytrauma
• Prolonged hospitalization (>10days)
• Pregnancy
• Known surgery cancellation within study period

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults Undergoing Spine Surgery	No Intervention	Adults Undergoing Spine Surgery on opiods

Primary Outcome Measures

Name	Time	Method
Current Opioid Misuse Measure (COMM) Score	Up to 12 months post-operatively	The Current Opioid Misuse Measure (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.

Secondary Outcome Measures

Name	Time	Method
Numerical Rating Scale (NRS) Score	Up to 12 months post-operatively	The Numerical Rating Scale (NRS) for pain intensity is an 11-point scale ranging from 0 to 10 that is used to measure a patient's self-reported pain intensity, with higher scores indicating more severe pain.

Trial Locations

Locations (1)

Mount Sinai Spine Center; 🇺🇸 New York, New York, United States