Lumbar Spine PathologyNCT06288256
Neurocognitive and Genomic Predictors of Persistent Pain and Opioid Misuse After Spine Surgery
An observational study of Lumbar Spine Pathology and Elective Spine Surgery, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spine Pathology, Elective Spine Surgery
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to 31 Aug 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: undergoing elective spine surgery
Who may be able to join
- Age over 18
- With diagnoses of lumbar, cervical or thoracic spine pathology, scheduled to undergo elective spine surgery with or without instrumentation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lumbar Spine Pathology, Elective Spine Surgery
- Being tested
- No Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Adults Undergoing Spine Surgery | Adults Undergoing Spine Surgery on opiods Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current Opioid Misuse Measure (COMM) Score
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.
Measured: Up to 12 months post-operatively
Secondary outcomes (1)
Numerical Rating Scale (NRS) Score
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.
Measured: Up to 12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start27 Mar 2023
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Why it stopped: PI leaving Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine PathologyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chinwe Nwaneshiudu, Icahn School of Medicine at Mount Sinai
- Investigators
- Chinwe Nwaneshiudu, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288256
- Sponsor's protocol ID
- STUDY-22-01390
- Status last verified
- Oct 2026
- First submitted
- 23 Feb 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).