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NCT03183713 · ClinicalTrials.gov registry record · NA
The Confounding Burden of Psychological Impairments in Cervical Spine Surgery
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 48
- Enrollment target
NCT03183713: Completed NA study, sponsored by NYU Langone Health.
NCT03183713 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 48 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03183713, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
Study Summary
This is a single-center prospective randomized investigation of patients undergoing surgical arthrodesis for single or multi-level cervical disease, resulting in cervical radiculopathy. Patients indicated for surgery for cervical degenerative disease (CDD) will be screened for yellow flags using validated tools to assess pain. Cognitive-behavioral therapy (CBT) will be used to modify yellow flags in spine patients. All patients at risk will be stratified by risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20). The goal of this study is to unmask the relationship between psychological distress and clinical outcomes in patients undergoing surgical treatment for cervical degenerative disease resulting in combinations of neck pain and radiculopathy, and to determine the effectiveness of a brief psychological intervention on subset of patients who screen positive for psychological distress prior to their surgeries.
Primary Outcome
The DRAM assesses and profiles patients: those showing no psychological distress, those at risk of developing major psychological overlay, and those that are distressed.
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy
- BEHAVIORAL Sham Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2017-06-05 |
| Est. Completion | 2024-07-10 |
| Phase | NA |
What the finished NCT03183713 record still lists
NCT03183713 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Cognitive Behavioral Therapy is the first listed.
NCT03183713 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03183713 about?
NCT03183713 is a clinical study titled "The Confounding Burden of Psychological Impairments in Cervical Spine Surgery". This is a single-center prospective randomized investigation of patients undergoing surgical arthrodesis for single or multi-level cervical disease, resulting in cervical radiculopathy. Patients indicated for surgery for cervical degenerative disease (CDD) will be screened for yellow flags using val...
What is the current status of trial NCT03183713?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2017-06-05. Estimated completion is 2024-07-10.
What interventions are being tested in trial NCT03183713?
The interventions under investigation include: Cognitive Behavioral Therapy (BEHAVIORAL), Sham Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT03183713?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03183713's enrollment target sits among peer trials
48 1381st of 2000 higher than 601 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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