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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 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 48 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03183713
The ClinicalTrials.gov registry entry for NCT03183713 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cognitive Behavioral Therapy is the first listed.
NCT03183713 reports 0 study locations.
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.
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