NCT04140344 The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
| NCT ID | NCT04140344 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Lumbar Spine Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 224 participants |
| Start Date | 2023-09-07 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 224 participants in total. It began in 2023-09-07 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this single-blind, randomized, controlled study is to assess the efficacy of "informative text messages" vs "traditional handouts" provided to lumbar spine surgery patients post-operatively.
Eligibility Criteria
Inclusion Criteria: 1. Primary lumbar fusion 1-4 levels 2. 18 years or older 3. Degenerative spine diagnosis 4. Answers YES to all the following screening questions: * Do you own a mobile phone that is capable of sending and receiving text messages? * Do you know how to text and feel comfortable texting? * Are you a regular (at least once a day) text-message user? * Are you agreeable to regular contact? Exclusion Criteria: 1. Prior lumbar fusions 2. Tumors/infection/trauma 3. Prisoners or institutionalized patients 4. Non-English speaking patients 5. Patients who smokes or with uncontrolled diabetes 6. Participants will be removed from study if discharged to a rehabilitation center or discharged beyond 7 days post-operatively (we are expecting \~15% of patients to be discharged to a rehabilitation center or discharged beyond 7 days post-operatively)
Contact & Investigator
Oren N Gottfried, MD FAANS
PRINCIPAL INVESTIGATOR
Duke Neurosurgery
Frequently Asked Questions
Who can join the NCT04140344 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lumbar Spine Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04140344 currently recruiting?
Yes, NCT04140344 is actively recruiting participants. Contact the research team at claudia.pamanes@duke.edu for enrollment information.
Where is the NCT04140344 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT04140344 clinical trial?
NCT04140344 is sponsored by Duke University. The principal investigator is Oren N Gottfried, MD FAANS at Duke Neurosurgery. The trial plans to enroll 224 participants.