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NCT05698914 · ClinicalTrials.gov registry record · NA
Telehealth Mindfulness After Spine Surgery
A NA study of Chronic Low Back Pain and Lumbar Spine Surgery, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 67
- Enrollment target
- 1
- Study location
NCT05698914 is a NA study of Chronic Low Back Pain and Lumbar Spine Surgery that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 67 participants, below the 591-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05698914, a NA study of Chronic Low Back Pain and Lumbar Spine Surgery, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 67 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this pilot clinical trial is to compare two behavioral interventions for patients who are recovering from lumbar spinal surgery for a degenerative spine condition. The study aims to answer the following questions: 1. Is it feasible and acceptable to deliver the interventions and conduct the study procedures in this patient population? 2. Do the interventions benefit patients with regard to pain-related, functional, opioid use, and psychosocial outcomes at 3 and 6 months after surgery, and does one intervention have more benefit than the other? Participants will be asked to do the following: 1. Complete self-report questionnaires online before spine surgery, and around 2 weeks, 3 months, and 6 months after spine surgery. 2. Complete a sensory pain task before spine surgery, and around 2 weeks, 3 months, and 6 months after spine surgery. 3. Around two weeks after surgery, participants will be randomly assigned by chance to one of two behavioral interventions - Mindfulness or Education. Participants will then be asked to attend 8, weekly sessions with a study treatment coach over telehealth (online with camera and microphone).
Conditions Studied
Interventions
- BEHAVIORAL Telehealth mindfulness-based intervention (MBI)
- BEHAVIORAL Telehealth Education
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2023-02-22 |
| Est. Completion | 2025-07-11 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05698914
The ClinicalTrials.gov registry entry for NCT05698914 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 591-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (89% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Chronic Low Back Pain appearing as the primary indexed condition, and to 2 interventions - of which Telehealth mindfulness-based intervention (MBI) is the first listed.
NCT05698914 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT05698914 about?
NCT05698914 is a clinical study titled "Telehealth Mindfulness After Spine Surgery". The goal of this pilot clinical trial is to compare two behavioral interventions for patients who are recovering from lumbar spinal surgery for a degenerative spine condition. The study aims to answer the following questions: 1. Is it feasible and acceptable to deliver the interventions and conduct...
What is the current status of trial NCT05698914?
This trial is currently completed. It is a NA study. The enrollment target is 67 participants. The study started on 2023-02-22. Estimated completion is 2025-07-11.
What conditions does trial NCT05698914 study?
This clinical trial studies the following conditions: Chronic Low Back Pain, Lumbar Spine Surgery, Postsurgical Pain.
What interventions are being tested in trial NCT05698914?
The interventions under investigation include: Telehealth mindfulness-based intervention (MBI) (BEHAVIORAL), Telehealth Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT05698914?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05698914 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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