Recruiting

Observational Study

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06288282

Conditions

Chronic Back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

No Intervention

Study Details

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.

Conditions

Chronic Back Pain

Study ID

NCT06288282

Start date

Dec 20, 2023

Status verified date

Jun, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Cancer pain

Study Design

Enrollment

130 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with chronic back pain with lumbar, cervical or thoracic spine diagnoses.

Interventions

No Intervention

No intervention will be used.

Primary outcome measure

  • Screener and Opioid Assessment for patients with pain revised (SOAPPR) [ Time Frame: within 12 months ]
  • Current Opioid misuse measure (COMM) surveys [ Time Frame: within 12 months ]

Central Contacts and Locations

Central contacts

Chinwe Nwaneshiudu, MD PhD

212 241 4203chinwe.nwaneshiudu@mountsinai.org

Locations

Mount Sinai Pain management centers

Recruiting

New York, New York, United States, 10029

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jun 12, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-06-12.