Elective Spine Surgery, Lumbar Spine Pathology
Conditions
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.
Interventions
OTHERNo Intervention
No Intervention
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactChinwe Nwaneshiudu, MD PhD
Outcome results
None listed